director of regulatory affairs

CareSource

<div>Job Summary: 
 
The Regulatory Affairs Director is responsible for leading activities of the Regulatory Affairs Department, including contracts, compliance, surveys, audits, investigations, reporting, plan development and renewal, credentialing, Fraud, Waste &amp; Abuse Special Investigations, provider network and relations, regulatory updates and compliance matters. 
 
Essential Functions:<ul><li>
Review, draft, negotiate and process agreements and amendments in accordance with organization guidelines.</li><li>
Lead projects involving the collection and submission of data and information related to government audits, surveys and requests.</li><li>
Oversee provider contracting, including letters of agreement and associated follow-up.</li><li>
Review, disseminate and handle fair hearing (FH) notices and decisions; manage FH calendar; attend FHs as needed, review and handle communications with OTDA and submit reports; prepare status reports and updates on cases.</li><li>
Lead activities of the Special Investigation Unit (SIU), including SIU reporting and internal investigations.</li><li>
Review and update applicable HIPAA policies and procedures in compliance with HIPAA laws and regulations.</li><li>
Review OIG/OMIG requirements and best practices for compliance and program integrity; review and update compliance materials, including manuals, policies and procedures, and handbooks, to comply with regulatory requirements.</li><li>
Make recommendations based on best practices and draft policies and procedures.</li><li>
Review DOH and CMS plan contracts and edit plan documents in compliance with contract requirements.</li><li>
Review, clarify and disseminate CMS memos and DOH guidance; keep abreast of related laws, regulations and official guidance.</li><li>
Coordinate document and requests of outside counsel for litigation matters.</li><li>
Oversee provider credentialing process and related activities.</li><li>
Draft policies, procedures, manuals, plan and member materials.</li><li>
Provide guidance and direction to Department staff.</li><li>
Perform any other job related duties as requested.</li></ul> 
Education and Experience:<ul><li>
Juris Doctor (J.D) degree from an accredited college/university required</li><li>
Five (5) years experience with Medicare and NY Medicaid managed care contracting and compliance required</li><li>
Previous leadership experience preferred</li></ul>
Competencies, Knowledge and Skills:<ul><li>
Strong customer service and team orientation</li><li>
Ability to adapt to a changing environment to achieve results</li><li>
Demonstrated leadership skills</li><li>
Skilled in organization, workflow analyses and management of details</li><li>
Advanced Microsoft Office skills, including Word</li><li>
Strong editing and proofreading skills</li><li>
Excellent written and oral communications skills</li><li>
Excellent time/project management and prioritization skills</li><li>
Ability to excel in fluid, dynamic environment</li></ul>
Licensure and Certification:<ul><li>
Current, unrestricted Attorney license required</li></ul>
Working Conditions:<ul><li>
General office environment; may be required to sit or stand for extended periods of time</li><li>
Ability to travel as required by the needs of the department.</li><li>
2 Days work from home; 3 Days work in Bronx office each week</li></ul>
Compensation Range:
$135,600.00 - $237,400.00
CareSource takes into consideration a combination of a candidate&rsquo;s education, training, and experience as well as the position&rsquo;s scope and complexity, the discretion and latitude required for the role, and other external and internal data when establishing a salary level. In addition to base compensation, you may qualify for a bonus tied to company and individual performance. We are highly invested in every employee&rsquo;s total well-being and offer a substantial and comprehensive total rewards package.
Compensation Type (hourly/salary):
Salary
Organization Level Competencies
<ul><li>Fostering a Collaborative Workplace Culture</li><li>
Cultivate Partnerships</li><li>
Develop Self and Others</li><li>
Drive Execution</li><li>
Influence Others</li><li>
Pursue Personal Excellence</li><li>
Understand the Business</li></ul><h2 class="jobSectionHeader"> 
This job description is not all inclusive. CareSource reserves the right to amend this job description at any time. CareSource is an Equal Opportunity Employer. We are dedicated to fostering an environment of belonging that welcomes and supports individuals of all backgrounds.</h2>
#LI-RW1</div>

Regulatory Affairs Director - Hybrid

Boehringer Ingelheim

<div>We are IMETA 
ROPU IMETA is a Regional Operating Unit consisting of 6 mid-sized Operating Units: India, Turkey, Southern Africa (South Africa &amp; Sub Sahara Africa) Northeast &amp; West Africa, Near East &amp; UAE, Saudi Arabia, Gulf &amp; East Africa (SAGEA).
IMETA is home to more than 47 nationalities. We are a powerhouse of talent, and we work together to ensure that we grow, nurture, and retain our talent. Uniting and working together is the key to our success. 
The Position 
 
We are hiring a Head of Regulatory Affairs (RA), responsible for SAGEA based at Riyadh , reporting to the Medical Director SAGEA.
 
 
The Head of RA collaborates with regional Regulatory Affairs to optimize and implement regional regulatory strategies for local markets. Maintains product registrations, ensure business continuity, while complying with internal and external regulations. The Head of RA partners with local management to set business strategies. Fosters strong interactions with authorities across the region and plays a leadership role within the local pharma association. Contributes to the setup of localization and local production. 
 
 
Tasks &amp; responsibilities 
<ul><li>Advice business on any new regulatory opportunities or risks arising in the RA environment to allow business to realize growth opportunities or avoid losses.
</li><li>Ensure proper budget allocation, resource planning and the right strategic prioritization.
</li><li>Maintaining product license to ensuring business continuity and monitor RA compliance against internal and external regulations and requirements.
</li><li>Advice local business on evolving RA risk and opportunity to ensure business realization of growth opportunities or avoid losses.
</li><li>Partner with local management team to set the local business strategies and develop local RA talents to accommodate business need.
</li><li>Supports on topics for regional and global projects.
</li><li>Interact and partner with Health Authorities playing a leadership role within the local pharma association.
</li><li>Play an important role in the setup of any localization and local production.
</li>Lead and manage development of the RA team. 
<li>
</li></ul>Requirements 
<ul><li>Bachelor&rsquo;s degree in Pharmaceuticals is required
</li><li>5+ years of extensive pharma experience with 4+years of experience into regulatory affairs in a multinational company
</li><li>2-3+ years of leadership experience with a proven track record of building high-performance teams.
</li><li>Previous experience and efficient interaction with local Regulatory Authorities
</li><li>Knowledge of local and awareness of international regulatory affairs regulation
</li><li>Business fluent in English in its oral and written form
</li><li>Previous experience within French speaking African countries will be an asset
</li><li>Strong organizational and communication skills
</li><li>Proactive and assertive attitude
</li><li>Project management skills
</li>Must be a Saudi National 
<li>
</li></ul>What happens Next? 
We are looking forward to receiving your application! We will then have a look at your CV. If we see a match, we will invite you for a screening interview. 
SPL Screening: 
In order to comply with applicable export control laws, Boehringer Ingelheim periodically screens business relations (including job applicants) against sanctioned party lists (&ldquo;SPL&rdquo;). These checks may be performed by Boehringer Ingelheim or by any of its Affiliates. You acknowledge that Boehringer Ingelheim and/or its Affiliates will screen you against SPL and that for this purpose your personal data may be processed in relevant databases, including databases of third-party vendors that perform SPL screening for or on behalf of Boehringer Ingelheim or its Affiliates which may be located or accessible outside the EU. Boehringer Ingelheim is committed to ensuring an adequate level of protection of your personal data.</div>

Head of Regulatory Affairs

Boston Scientific

<div>Additional Location(s): US-MN-Arden Hills 
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance 
At Boston Scientific, we&rsquo;ll give you the opportunity to harness all that&rsquo;s within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we&rsquo;ll help you in advancing your skills and career. Here, you&rsquo;ll be supported in progressing &ndash; whatever your ambitions. 
<div><div><div><div>About the role:
Boston Scientific was recognized as a Glassdoor Best Place to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day. 
The Associate Director, Regulatory Affairs &ndash; Pulsed Field Ablation (PFA) is responsible for leading global regulatory strategy and execution for Boston Scientific&rsquo;s Pulsed Field Ablation portfolio, the company&rsquo;s most strategically critical and fastest-growing segment within Electrophysiology. 
In this role, you will provide strategic regulatory leadership and serve as the primary regulatory point of contact for PFA strategy, escalations, and program-level decision-making across new products, sustaining activities, global expansion, and compliance initiatives. 
You will partner closely with R&amp;D, clinical, quality, medical safety, operations, program management, and global and regional regulatory teams to support business objectives. 
This role owns regulatory decision-making for a rapidly expanding and increasingly complex PFA portfolio and leads a high-performing regulatory team to deliver predictable, high-quality regulatory outcomes worldwide. 
Your responsibilities will include: 
Regulatory strategy and execution:<ul><li>Define and execute regulatory strategies for the PFA portfolio across the product lifecycle, including development, clinical, submission, approval, launch, sustaining, and global expansion</li><li>Oversee preparation and submission of global regulatory applications and documentation, including 510(k), PMA, IDE, EU MDR/CE mark, supplements, reports, and international registrations, as applicable</li><li>Provide regulatory leadership on clinical strategies and regulatory positioning for PFA clinical programs and next-generation initiatives</li><li>Provide technical, clinical, and strategic regulatory guidance during strategy development, submission preparation, and regulatory pathway planning</li><li>Assess regulatory risks, timeline impacts, and decision trade-offs, and provide recommendations to business and functional leadership</li><li>Review and edit submissions and other regulatory deliverables prepared by team members</li></ul> 
Leadership:<ul><li>Serve as the primary regulatory owner for the PFA portfolio, providing direction on key issues, escalations, and cross-functional decisions</li><li>Provide day-to-day leadership, prioritization, mentoring, and escalation support for regulatory managers and team members</li><li>Establish project priorities, allocate workload, and ensure appropriate regulatory support across the portfolio</li><li>Lead, develop, and mentor a team of regulatory managers and senior individual contributors</li><li>Build leadership depth, succession capability, and regulatory excellence within the PFA regulatory organization</li><li>Support broader electrophysiology regulatory affairs initiatives, including organizational priorities, capability building, and process improvements</li></ul> 
Internal and external stakeholder collaboration:<ul><li>Drive collaboration and alignment with cross-functional stakeholders to integrate regulatory considerations into product and business decisions</li><li>Coordinate strategic alignment across key sites and partners supporting PFA execution</li><li>Lead strategic interactions with FDA, notified bodies, competent authorities, and other regulatory agencies</li></ul> 
Compliance and process improvement:<ul><li>Provide regulatory support for audits, inspections, post-market issues, field actions, and other compliance activities</li><li>Contribute to development of best practices, process improvements, and broader regulatory affairs initiatives</li><li>Support and maintain quality initiatives in accordance with Boston Scientific quality policy and applicable procedures</li></ul> 
Qualifications: 
Required qualifications:<ul><li>Bachelor&rsquo;s degree required or equivalent combination of education and experience</li><li>Minimum of 12 years' experience in regulatory affairs or a combination of regulatory affairs and closely related functions within the regulated medical device industry, including clinical or quality</li><li>Minimum of 5 years' experience in people management, including leadership of managers, senior regulatory professionals, or both</li><li>Demonstrated experience leading global regulatory strategy and execution for complex medical device portfolios</li><li>Extensive experience with regulatory submissions and lifecycle management, including 510(k), IDE, PMA, EU MDR/CE mark, and international registrations</li><li>Proven track record of direct health authority interactions, including leading or supporting regulatory agency meetings and submissions</li><li>Experience managing multiple concurrent regulatory programs or submissions with competing timelines and priorities</li></ul> 
Preferred qualifications:<ul><li>Advanced degree, including MS, PhD, JD, or equivalent</li><li>Prior experience in electrophysiology, ablation, cardiovascular devices, or catheter-based technologies</li><li>Experience supporting integrated portfolios involving disposables, capital equipment, system-level changes, and clinical evidence strategies</li><li>Experience supporting audits, inspections, post-market issues, and sustaining activities</li><li>Strong communication, collaboration, organizational, and influencing skills</li><li>Demonstrated ability to operate effectively in complex, fast-paced, and ambiguous environments</li></ul></div></div></div></div> 
Requisition ID: 628715
Minimum Salary: $137700
Maximum Salary: $261600 
The anticipated compensation listed above and the value of core and optional employee benefits offered by Boston Scientific (BSC) &ndash; see www.bscbenefitsconnect.com&mdash;will vary based on actual location of the position and other pertinent factors considered in determining actual compensation for the role. Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. 
Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). 
Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). 
For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. 
Boston Scientific transforms lives through innovative medical technologies that improve the health of patients around the world. As a global medical technology leader for more than 45 years, we advance science for life by providing a broad range of high-performance solutions that address unmet patient needs and reduce the cost of healthcare. Our portfolio of devices and therapies helps physicians diagnose and treat complex cardiovascular, respiratory, digestive, oncological, neurological and urological diseases and conditions. Learn more at www.bostonscientific.com and follow us on LinkedIn. 
Boston Scientific Corporation has been and will continue to be an equal opportunity employer. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. 
Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. Boston Scientific continues to evaluate its policies and protocols regarding the COVID-19 vaccine and will comply with all applicable state and federal law and healthcare credentialing requirements. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company&rsquo;s policies or protocols change with regard to COVID-19 vaccination.</div>

Associate Director, Regulatory Affairs - Pulsed Field Ablation (PFA)

Ghrasa Laboratory

We Are Hiring: DRAP Regulatory Affairs OfficerWe are looking for an experienced and detail-oriented DRAP Regulatory Affairs Officer to join our growing team and ensure full compliance with regulatory requirements for medical and laboratory equipment in Pakistan.Key Responsibilities:<ul><li>Manage product registrations with DRAP (Class A, B, C &amp; D devices)</li><li>Ensure compliance with DRAP rules, guidelines, and documentation</li><li>Prepare and submit regulatory dossiers and technical files</li><li>Liaise with DRAP officials and regulatory bodies</li><li>Monitor regulatory updates and implement changes internally</li><li>Support marketing team with compliant product claims and advertisements</li></ul>Requirements:<ul><li>Bachelor&rsquo;s/Master&rsquo;s in Pharmacy or relevant field</li><li>3&ndash;5 years of experience in DRAP regulatory affairs</li><li>Strong knowledge of DRAP regulations and medical device classification</li><li>Experience with product registration and licensing processes</li><li>Excellent documentation and communication skills</li></ul>What We Offer:<ul><li>Competitive salary package with other company benefits</li><li>Career growth in a rapidly expanding company</li><li>Professional and compliance-driven work environment</li></ul>Apply Now: Send your CV to: HR@ghrasa.com Whatsapp: 0317-3172913Only shortlisted candidates will be contactedWork Location: In person

DRAP Regulatory Affairs Officer

Agios Pharmaceuticals

<div><div>Director, Regulatory Strategy (Pediatrics)
Who we are:
At Agios, we are fueled by connections to transform rare diseases. We foster an inclusive, collaborative culture &ndash; one that sparks bold thinking and strengthens our connections with each other and with the rare disease communities we serve. We embrace diverse backgrounds with respect, active listening, and a commitment to inclusion &ndash; because our differences shape how we hire, collaborate, and innovate. Our team&rsquo;s proven track record of executional excellence, combined with our depth of expertise and dedication, enables us to develop innovative medicines that reflect the priorities of rare disease communities. Our commitment is more than scientific &ndash; it&rsquo;s deeply personal, grounded in the meaningful connections we have built. To learn more, visit www.agios.com and follow Agios on LinkedIn and X.
The impact you will make:
Agios Pharmaceuticals is searching for a dynamic Director, Regulatory Strategy to join our growing Regulatory Strategy team. We want someone who cares about this important work, and who&rsquo;s driven to connect to our mission of helping these patient communities. The Director, Regulatory Strategy will be responsible for developing regulatory strategies to support pediatric clinical development plans, working cross-functionally across the organization. This individual will lead cross-functional teams in preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support development, registration, or life cycle management activities.
What you will do:<ul><li>
Develop and execute global regulatory pediatric strategy including the potential to accommodate expedited development needs</li><li>
Provide global regulatory expertise in support of the development, review, and approval of cross-functionally developed strategies and documents intended to enable clinical trials and marketing authorizations for pediatric programs.</li><li>
Plan, lead, develop, and review regulatory submissions, such as clinical trial applications, marketing applications, and life-cycle management submissions for pediatric programs.</li><li>
Plan and lead health authority interactions, as needed, including the development and/or review of associated documents</li><li>
Engage with Regulatory Authorities on project-related matters</li><li>
Ensure adherence to current regulations associated with regulatory activities</li></ul>
What you bring:<ul><li>
Bachelor&rsquo;s degree in life-sciences or related scientific discipline required; advanced degree (PhD, PharmD, or MS) preferred</li><li>
10+ years of experience in Regulatory Affairs within the biopharmaceutical industry</li><li>
7+ years of experience with pediatric plans (both in US and EU)</li><li>
Experience leading preparations for health authority interactions and development of briefing documents</li><li>
Strong knowledge of drug development, FDA, EMA and ICH guidelines and regulations</li><li>
Excellent organizational and communication skills, both written and verbal</li><li>
Ability to work independently as well as part of a team environment</li><li>
Positive attitude, energetic and proactive</li><li>
Proven ability to manage multiple projects, identify and resolve regulatory issues</li><li>
Strong interpersonal skills and the ability to effectively work with others</li></ul> 
Concerned that you don&rsquo;t check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other&rsquo;s differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you&rsquo;re excited about this role but your previous experience doesn&rsquo;t align perfectly with the job description, we still encourage you to apply. You may be just the right candidate for this role or another opening!
Work Location:
Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description..
What we will give you:<ul><li>
Deliberate Development. Your professional growth as one of our top priorities.
We&rsquo;re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you&rsquo;re at your best, we&rsquo;re at our best.</li><li>
Flexibility. We&rsquo;re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you&rsquo;re at your best, we&rsquo;re at our best.</li><li>
Premium benefits package. We invest in the health, wellbeing, and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.</li><li>
Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.</li><li>
The current base salary range for this position is expected to be between $183,549 and $275,324 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.</li><li>
Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.</li><li>
Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We&rsquo;re continuously looking to improve the inclusivity of our workforce.</li><li>
Commitment to community. We&rsquo;re an active participant in the communities that surround us &ndash; the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.</li></ul> 
Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.</div></div>

Director, Regulatory Strategy (Pediatrics)

Delta Pharma

<div>
 
 📌
 
 Key Responsibilities:
 
 
 
 
 
 <ul>
 <li>
 Prepare and review
 
 CTD dossiers
 
 for submission to the Egyptian Drug Authority.
 </li>
 <li>
 Execute regulatory activities for
 
 new registrations, variations, and renewals
 
 .
 </li>
 <li>
 Follow up with EDA on submitted files and handle
 
 deficiency letters and responses
 
 .
 </li>
 <li>
 Ensure submitted documents comply with
 
 local Egyptian and veterinary requirements
 
 .
 </li>
 <li>
 Coordinate with internal departments (R&amp;D, Quality, Production) to collect required documents.
 </li>
 <li>
 Track submission timelines and maintain proper documentation records.
 </li>
 <li>
 Support pilot batch follow-up and
 
 stability data compilation
 
 .
 </li>
 <li>
 Assist in audit readiness and regulatory documentation support.
 </li>
 <li>
 Guide junior team members on daily regulatory tasks.
 </li>
 </ul>
 
 
 
 
 
 📌 Qualifications:
 
 
 
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Pharmacy or Veterinary Medicine (Pharmacy preferred).
 </li>
 <li>
 
 7&ndash;13 years of experience
 
 in Regulatory Affairs in Egypt (human &amp; veterinary).
 </li>
 <li>
 Hands-on experience with
 
 EDA submission processes
 
 .
 </li>
 <li>
 Strong knowledge of
 
 CTD format and lifecycle activities
 
 .
 </li>
 <li>
 Experience in handling
 
 deficiency responses and follow-ups
 
 .
 </li>
 </ul>
 
 
 
 
 
 📌 Preferred Skills:
 
 
 
 
 
 <ul>
 <li>
 Good organizational and follow-up skills
 </li>
 <li>
 Attention to detail and compliance awareness
 </li>
 <li>
 Ability to manage multiple files simultaneously
 </li>
 <li>
 Basic team supervision
 </li>
 </ul>
 
 
</div>

Regulatory Affairs Section Head

Spyre Therapeutics

<div><div>Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease (&quot;IBD&quot;) and rheumatic diseases. Spyre's pipeline includes investigational extended half-life antibodies targeting &alpha;4&beta;7, TL1A, and IL-23.</div>
Role Summary:

As the Associate Director, Regulatory Affairs (CMC and Devices), you will play a key role in executing CMC and potentially Device regulatory activities within our organization. You will be responsible for authoring, reviewing, and coordinating CMC and Device regulatory submissions that enable Spyre to initiate and advance clinical trials. You will also contribute to regulatory strategies by implementing CMC and Device-related plans, ensuring compliance with evolving regulatory requirements, and supporting interactions with global health authorities.

You will lead submissions across multiple drug candidates and work closely with Regulatory colleagues, Technical Operations, Quality, and external partners to ensure timely and compliant delivery of high-quality regulatory documents.

Key Responsibilities:
<ul>
<li>Regulatory Submissions: Plan and coordinate global regulatory submissions, including INDs, late-stage IND amendments, IMPDs, CTAs, and annual reports, ensuring high-quality, compliant documentation to support new and ongoing clinical programs.</li>
<li>Technical Authoring: Independently author and compile Module 2 and Module 3 content, including quality overall summaries, drug substance, drug product and regional sections, stability summaries, comparability assessments, and supporting technical reports.</li>
<li>Health Authority Interactions: Prepare clear, scientifically sound responses to CMC and device-related questions from global regulatory agencies (FDA, EMA, PMDA, and ROW health authorities). Prepare meeting requests, background material and meeting presentation materials to support health authority interactions to progress clinical development milestone.</li>
<li>Device &amp; Combination Product Support: Contribute to regulatory strategy and documentation for drug-device combination products, including device technical documentation and integration into clinical regulatory submissions.</li>
<li>Regulatory Strategy Execution: Implement CMC and device regulatory strategies in collaboration with regulatory leadership to support late-stage clinical development and clinical trial progression.</li>
<li>Cross-functional Collaboration: Work closely with Technical Operations, Manufacturing, Analytical Development, Quality, Clinical, and external partners to collect, verify, and integrate technical data into regulatory submissions.</li>
<li>Other duties as assigned.</li>
</ul>
Ideal Candidate:
<ul>
<li>Bachelor's degree with a minimum of 6+ years of experience in CMC regulatory affairs, supporting clinical-stage biologics programs (or equivalent combination of education and experience).</li>
<li>Demonstrated hands-on authoring experience for late-stage IND submissions and amendments, including direct responsibility for CMC sections and supporting technical documentation.</li>
<li>Proven experience preparing responses to health authority questions related to CMC and device/combo product topics during clinical development.</li>
<li>Strong understanding of global CMC regulatory requirements and guidelines including FDA, EMA, ICH, and applicable device regulations.</li>
<li>Experience supporting biologics and drug-device combination products such as prefilled syringes, autoinjectors, or delivery devices; familiarity with companion diagnostics is a plus.</li>
<li>Exceptional technical writing skills, with the ability to clearly communicate complex technical information in regulatory documents and health authority responses.</li>
<li>Meticulous attention to detail, strong organizational skills, and the ability to manage multiple concurrent submissions and timelines in a fast-paced environment.</li>
<li>Excellent written and verbal communication skills, with the ability to collaborate effectively across technical and cross-functional teams.</li>
<li>Proficiency with regulatory submission and document management systems (e.g., Veeva RIM, eCTD publishing platforms, document repositories).</li>
</ul>
What We Offer:
<ul>
<li>Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.</li>
<li>Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare &amp; retirement benefits.</li>
<li>Unlimited PTO</li>
<li>Two, one-week company-wide shutdowns each</li>
<li>Commitment to provide professional development opportunities.</li>
<li>Remote working environment with frequent in-person meetings to address complex problems and build relationships.</li>
</ul>
The expected salary range offer for this role is $175,000 to $195,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.<div>
As an equal opportunity employer, Spyre is committed to a diverse workforce. Employment decisions regarding recruitment and selection will be made without discrimination based on race, color, religion, national origin, gender, age, sexual orientation, physical or mental disability, genetic information or characteristic, gender identity and expression, veteran status, or other non-job-related characteristics or other prohibited grounds specified in applicable federal, state and local laws. We also embrace differences in experience and background, and welcome diversity of opinions and thought with active recruitment designed to create a stronger and better Spyre that is focused on developing life-changing products for patients.

Spyre Therapeutics, along with other biotech companies, has become aware of a surge in email scams targeting prospective job candidates within our industry. Please be aware that official recruiters at Spyre Therapeutics only use email addresses with the domain &quot;@spyre.com.&quot; We want to also emphasize that we never request candidates to make any purchases or divulge sensitive personal information via email.

Please also be aware that all job postings will be listed on our website at spyre.com/careers/.</div></div>

Associate Director, Regulatory Affairs CMC and Devices

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