manager of regulatory affairs

Clark Associates

<div><h2 class="jobSectionHeader">Job Summary</h2>
The Senior Manager of Regulatory Affairs plays a critical leadership role in guiding and executing regulatory strategy across Clark Associates&rsquo; product portfolio. Reporting to the Director of Regulatory Affairs, this role is responsible for managing a regulatory team, navigating complex federal and state regulatory frameworks, and supporting process improvement as the team grows. 
 
This role requires deep experience working with U.S. regulatory bodies such as the FDA, FTC, EPA, and CPSC, as well as the judgment and communication skills needed to manage regulatory nuance, ambiguity, and competing business priorities. The ideal candidate brings both technical regulatory expertise and proven people leadership experience, with a strong preference for experience in sustainability and environmental regulations impacting plastics, paper, and disposable products.<h2 class="jobSectionHeader">
Responsibilities</h2><ul><li>
Lead, manage, and develop a team of regulatory professionals, providing coaching, prioritization, performance management, and professional growth support.</li><li>
Oversee regulatory strategy and execution across applicable federal, state, and local requirements, including but not limited to FDA, FTC, EPA, and CPSC obligations.</li><li>
Monitor, interpret, and assess new and emerging regulations, translating regulatory requirements into clear, actionable guidance for cross-functional business teams.</li><li>
Partner closely with Trade, Quality, Sourcing, Merchants and Legal to enable compliant product development, labeling, claims, and commercialization.</li><li>
Lead regulatory impact assessments for changes in law or guidance, including mitigation strategies and recommended business actions.</li><li>
Represent the company in interactions with regulatory agencies, trade associations, and external stakeholders as appropriate.</li><li>
Develop and maintain internal regulatory processes, guidance documents, and training materials to drive consistency and institutional knowledge.</li><li>
Support enterprise compliance initiatives, including audits, investigations, and response to regulatory inquiries.</li><li>
Prepare summaries, briefings, and recommendations to support leadership decision-making.</li><li>
Contribute to the continued development and maturity of the Regulatory Affairs function as the business scales.</li></ul><h2 class="jobSectionHeader">
Physical Requirements</h2><ul><li>
Work is performed while sitting/standing and interfacing with a personal computer.</li><li>
Requires the ability to communicate effectively using speech, vision, and hearing.</li><li>
Requires the regular use of hands for simple grasping and fine manipulations.</li><li>
Requires occasional bending, squatting, crawling, climbing, and reaching.</li><li>
Requires the ability to occasionally lift, carry, push, or pull medium weights, up to 50lbs.</li></ul><h2 class="jobSectionHeader">
Remote Work Qualifications</h2><ul><li>
Access to a reliable and secure high-speed internet connection. Cable or fiber internet connections (at least 75mbps download/10mbps upload) are preferred, as satellite connections often cannot support the technologies used to perform day-to-day tasks.</li><li>
Access to a home router and modem.</li><li>
A dedicated home office space that is noise- and distraction-free. The space should have strong wireless connection or a wired Ethernet connection (wired connection is preferred, if possible).</li><li>
A valid, physical address (apartment, suite, etc.). PO Boxes are not supported, as a physical address is required for you to receive your computer equipment.</li><li>
The desire and ability to work and communicate with other team members via chat, webcam, etc.</li><li>
Legal residents of one of the following states: (AK, AL, AR, AZ, CT, DE, FL, GA, IA, ID, IN, KS, KY, LA, MD, ME, MI, MN, MO, MS, NC, ND, NH, NM, NV, OH, OK, PA, SC, SD, TN, TX, UT, VA, VT, WI, WV, or WY). H-1B Visa Sponsorship Not Available, W2 only.</li></ul><h2 class="jobSectionHeader">
Experience</h2><ul><li>
5+ years of experience managing people in a regulatory, compliance, or related function.</li><li>
Demonstrated experience navigating U.S. federal and state regulations, including interaction with agencies such as FDA, FTC, EPA, and CPSC.</li><li>
Experience evaluating and interpreting regulatory requirements across complex or evolving compliance landscapes.</li><li>
Preferred experience with sustainability, environmental, or materials-based regulations impacting plastics, paper, and disposable products.</li><li>
Proven ability to provide practical, business-focused regulatory guidance.</li></ul><h2 class="jobSectionHeader">
Education</h2>
This role does not require a degree. We value relevant skills and experience and alignment with our core values above all else.<h2 class="jobSectionHeader">
Desired Traits &amp; Skills</h2><ul><li>
Strong leadership presence with the ability to influence, mentor, and build high-performing teams.</li><li>
Comfortable navigating nuance, ambiguity, and competing regulatory interpretations.</li><li>
Excellent communication skills, with the ability to translate complex regulatory concepts into clear guidance for non-technical audiences.</li><li>
Highly organized, with the ability to manage multiple priorities in a fast-paced, evolving environment.</li><li>
Collaborative and solutions-oriented approach to cross-functional problem solving.</li><li>
High level of professionalism, discretion, and integrity when handling sensitive regulatory matters.</li></ul><h2 class="jobSectionHeader">
Company Overview</h2>
A rapidly growing, multi-divisional company headquartered in Lancaster, Pennsylvania with services supporting all of Clark&rsquo;s distribution methods in the food service industry.<h2 class="jobSectionHeader">
Benefits</h2><ul><li>
Medical</li><li>
Vision</li><li>
Dental</li><li>
PTO</li><li>
Paid Maternity Leave</li><li>
Paid Parental Leave</li><li>
Life Insurance</li><li>
Disability</li><li>
Dependent Care FSA</li><li>
401(k) matching</li><li>
Employee Assistance Program</li><li>
Wellness Incentives</li><li>
Company Discounts</li><li>
AT&amp;T &amp; Verizon Discount</li><li>
Bonus Opportunities</li><li>
Accident Insurance</li><li>
Critical Illness Insurance</li><li>
Adoption Assistance</li></ul><h3 class="jobSectionHeader">
Available at HQ Locations Only</h3><ul><li>
On-Site Fitness Centers</li><li>
Dog-friendly Offices</li></ul></div>

Senior Manager, Regulatory Affairs

Revolut

<div>About Revolut
People deserve more from their money. More visibility, more control, and more freedom. Since 2015, Revolut has been on a mission to deliver just that. Our powerhouse of products &mdash; including spending, saving, investing, exchanging, travelling, and more &mdash; help our 70+ million customers get more from their money every day.
As we continue our lightning-fast growth,&zwnj; 2 things are essential to our success: our people and our culture. In recognition of our outstanding employee experience, we've been certified as a Great Place to Work&trade;. So far, we have 13,000+ people working around the world, from our offices and remotely, to help us achieve our mission. And we're looking for more brilliant people. People who love building great products, redefining success, and turning the complexity of a chaotic world into the simplicity of a beautiful solution.
About the role
The Regulatory Affairs team builds transparent relationships with regulators to keep Revolut moving forward with confidence. They stay ahead of regulatory change, provide timely responses to enquiries, and work across the business to ensure compliance is always in step with innovation.
We're looking for a Senior Regulatory Affairs Manager to manage regulatory engagement across the UAE.
You'll ensure our relationships with regulators are transparent by shaping the local regulatory engagement strategy, managing regulatory communications, and providing regulatory advice to leadership.
Up to shape what's next in finance? Let&rsquo;s get in touch.
What you&rsquo;ll be doing<ul><li>
Leading local regulatory engagement, ensuring interactions are transparent, professional, and consistent with Revolut&rsquo;s global standards</li><li>
Anticipating regulatory change and expectations, translating these into actionable strategies</li><li>
Ensuring regulatory commitments and remediation actions are tracked to completion</li><li>
Supporting the end-to-end management of regulatory inspections and audits</li><li>
Partnering with Product Owners and the Legal team to launch new features within the UAE's regulatory framework, and proactively engaging with regulators to test innovative solutions</li><li>
Preparing high-quality management information and briefing materials, ensuring regulatory matters are escalated when required</li><li>
Providing strategic regulatory advice and counsel to senior management and the group</li><li>
Building processes and documentation in a scalable and sustainable way</li><li>
Being a champion for conduct and compliance across the business</li></ul>
What you'll need<ul><li>
7+ years of experience in regulatory affairs, compliance, or risk management within a top-tier financial institution, fintech, or a regulatory body</li><li>
An existing professional network within the regulatory environment in the UAE</li><li>
Familiarity with key regulatory compliance regimes</li><li>
An understanding of the payments systems and markets with a focus on technology and mobile applications</li><li>
Excellent stakeholder management, communication, project management, and negotiation skills</li><li>
Knowledge of best practice in regional financial institutions regulations</li><li>
Problem-solving and decision-making skills to analyse complex information and identify the key issue/action to drive resolutions</li><li>
Experience coaching and inspiring people</li></ul>
Nice to have<ul><li>
A solid academic background from a top-tier university, including a degree in law, public policy, business administration, or finance</li><li>
An advanced qualification (LLB/LLM, CA, CS, CFA, etc.)</li></ul>
Building a global financial super app isn&rsquo;t enough. Our Revoluters are a priority, and that&rsquo;s why in 2021 we launched our inaugural D&amp;I Framework, designed to help us thrive and grow everyday. We're not just doing this because it's the right thing to do. We&rsquo;re doing it because we know that seeking out diverse talent and creating an inclusive workplace is the way to create exceptional, innovative products and services for our customers. That&rsquo;s why we encourage applications from people with diverse backgrounds and experiences to join this multicultural, hard-working team.
Important notice for candidates:
Job scams are on the rise. Please keep these guidelines in mind when applying for any open roles.<ul><li>Only apply through official Revolut channels. We don&rsquo;t use any third-party services or platforms for our recruitment.</li><li>Always double-check the emails you receive. Make sure all communications are being done through official Revolut emails, with an @revolut.com domain.</li></ul>
We won't ask for payment or personal financial information during the hiring process. If anyone does ask you for this, it&rsquo;s a scam. Report it immediately.
By submitting this application, I confirm that all the information given by me in this application for employment and any additional documents attached hereto are true to the best of my knowledge and that I have not wilfully suppressed any material fact. I confirm I have disclosed if applicable any previous employment with Revolut. I accept that if any of the information given by me in this application is in any way false or incorrect, my application may be rejected, any offer of employment may be withdrawn or my employment with Revolut may be terminated summarily or I may be dismissed. By submitting this application, I agree that my personal data will be processed in accordance with Revolut's Candidate Privacy Notice</div>

Regulatory Affairs Manager

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

SkyBlue Media

<div>This position will be based in Dubai UAE. Please apply if you are in Dubai or OPEN FOR RELOCATION.
The top budget for this role is 15K AED to 20K AED per month. Please apply accordingly
Role Overview
Antweave is seeking a high-caliber Regulatory Affairs &amp; Licensing Lead to spearhead our institutional entry into the UAE&rsquo;s digital asset ecosystem.
You will be the primary architect of our licensing strategy, responsible for securing and maintaining our VARA (Virtual Assets Regulatory Authority) Full Market Product licenses and navigating the RAK Digital Assets Oasis (RAK DAO) legal frameworks.
Your mission is to ensure that our platform for fractional ownership of Real-World Assets (RWA) is not just compliant, but sets the gold standard for regulated tokenization in the region.
<h4 class="jobSectionHeader">Key Responsibilities
</h4>1. Licensing &amp; Statutory Approvals<ul><li>
VARA Management: Lead the end-to-end application process for VARA licenses (specifically Broker-Dealer).
</li><li>RAK DAO Integration: Manage the setup and &quot;legal wrapper&quot; structures within RAK DAO, ensuring our DAO governance aligns with Ras Ras Ras Al Khaimah&rsquo;scifice zone regulations.
</li><li>Regulatory Liaison: Act as the primary point of contact for regulators, managing all inspections, audits, and &quot;No Objection Certificate&quot; (NOC) requests.
</li></ul>2. Compliance Framework Development
<ul><li>Rulebook Implementation: Translate VARA&rsquo;s Compulsory Rulebooks (Compliance &amp; Risk, AML/CFT, Cybersecurity, etc.) into actionable internal SOPs.
</li><li>RWA Legal Structuring: Collaborate with legal counsel to ensure the &quot;off-chain&quot; asset (real estate, art, etc.) is perfectly mirrored by the &quot;on-chain&quot; token under UAE Law.
</li><li>Investor Onboarding: Oversee the development of KYC/KYB and AML workflows that satisfy both UAE federal law and specific Virtual Asset standards.
</li></ul>3. Strategic Advisory
<ul><li>Product Roadmap Alignment: Advise the tech and product teams on how new features (e.g., secondary market trading or staking) impact our licensing perimeter.
</li><li>Governance: Help establish the Board-level Risk and Compliance Committees required for regulated financial entities in Dubai.
</li></ul>Candidate Profile Experience &amp; Qualifications:
<ul><li>6+ years of experience in legal, compliance, or regulatory affairs within Fintech, Blockchain, or Traditional Finance (Private Equity/REITs).
</li><li>Proven Track Record: Direct experience in successfully obtaining licenses from VARA, ADGM (FSRA), or DIFC (DFSA).
</li><li>RWA Knowledge: Deep understanding of the legal hurdles involved in fractionalizing physical assets (SPV structures, land registry integrations, etc.).
</li><li>Education: Bachelor&rsquo;s or Master&rsquo;s degree in Law, Finance, or a related field. Professional certifications (CAMS, ICA) are highly preferred. Soft Skills:
</li><li>The &quot;VARA Whisperer&quot;: Exceptional communication skills with the ability to present complex technical concepts to regulators clearly.
</li><li>Entrepreneurial Grit: Comfortable working in a fast-paced startup environment where the regulatory &quot;goalposts&quot; are often moving.
</li></ul>Why Join Antweave?<ul><li>
Be at the forefront of the $16 Trillion RWA tokenization market.
</li><li>Shape the regulatory landscape of the UAE&rsquo;s most ambitious Web3 project.
</li><li>Competitive salary + equity/token options</li></ul></div>

Head of Regulatory Affairs & Licensing (RWA Tokenization)

Amgen

<div>
 HOW MIGHT YOU DEFY IMAGINATION?
 
 
 <ul>
 <li>
 If you feel like you&rsquo;re part of something bigger, it&rsquo;s because you are. At Amgen, our shared mission&mdash;to serve patients&mdash;drives all that we do. It is key to our becoming one of the world&rsquo;s leading biotechnology companies. We are global collaborators who achieve together&mdash;researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It&rsquo;s time for a career you can be proud of. Join us.
 
 
 </li>
 </ul>
 Job purpose:
 
 
 <ul>
 <li>
 As a member of this fast-pace, complex and dynamic region, MEA Regulatory Affairs Senior Associate will be accountable for labeling and packaging activities management for Middle East North African region for Amgen portfolio for pipeline, inline and biosimilars; as well participating in labeling projects internally and externally for e-labeling implementation; and execution of Regulatory Affairs processes in the local office.
 
 
 </li>
 </ul>
 Job Responsibilities:
 
 
 <ul>
 <li>
 Deliver both strategic and administrative system support for ongoing maintenance with Lifecyle management and updates to our existing platforms and systems, to ensure data standards are 100% accurate, as to enable effective reporting and data analytics
 </li>
 <li>
 Manage Performance Excellence through collection, analyzing &amp; disseminating relevant information to team(s) as appropriate
 </li>
 <li>
 Participate in local regulatory process improvements initiatives
 </li>
 <li>
 Build newsletter, annual Report, data analysis with follow up on Key Performance Indicators and Metrics
 </li>
 <li>
 Ensure delivery of right first time label source text for artwork creation
 </li>
 <li>
 Support efficiently the filing plan of different marketing application submissions and products life cycle management filings by providing regional product information (leaflet and SmPC) source texts and artworks in a timely manner
 </li>
 <li>
 Ensure implementation of master artworks as per Amgen procedures, SKU strategy and timelines with high quality to serve our patients in MENA region
 </li>
 <li>
 Access the translation agency systems to request the label translation and track the job readiness and timelines.
 </li>
 <li>
 Perform regional prescribing information translation review: 100% review of both content and format
 </li>
 <li>
 Perform the role of source text owner/approver and artwork reviewer/approver in the system
 </li>
 <li>
 Trigger the existing label revision when alerted by global RA team.
 </li>
 <li>
 Support in product launch and ensure supply continuity by creating and revising the commercial pack artworks (leaflet, label, blister, outer pack)
 </li>
 <li>
 Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.
 
 
 </li>
 </ul>
 Qualifications:
 
 
 <ul>
 <li>
 Experience +2 years in Regulatory Affairs
 </li>
 <li>
 Current/ previous experience in working as part of an MNC employer
 </li>
 <li>
 Pharmacist, biologist, chemist-medical background
 </li>
 <li>
 Fluent in English and Arabic for translation review purpose ( French is a huge plus)
 </li>
 <li>
 A minimum knowledge of Middle East Africa regulatory requirements
 </li>
 <li>
 Strong communication skills (verbal &amp; written) with ability to understand and communicate the scientific information and anticipate/prevent potential issues
 </li>
 <li>
 Conflict Management skillset &amp; ability to deal with multiple stakeholders simultaneously.
 
 
 </li>
 </ul>
 What You Can Expect Of Us
 
 
 As we work to develop treatments that take care of others, so we work to care for our teammates&rsquo; professional and personal growth and well-being.
 
 
 <ul>
 <li>
 Vast opportunities to learn and move up and across our global organization
 </li>
 <li>
 Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
 </li>
 <li>
 Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
 
 
 </li>
 </ul>
 Apply now for a career that defies imagination
 
 
 In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us.
 
 
 careers.amgen.com
 
 
 Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
 
 
 We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.
</div>

MEA Regulatory Affairs Senior Associate

<div><h2 class="jobSectionHeader">HOW MIGHT YOU DEFY IMAGINATION?</h2><ul><li> 
If you feel like you&rsquo;re part of something bigger, it&rsquo;s because you are. At Amgen, our shared mission&mdash;to serve patients&mdash;drives all that we do. It is key to our becoming one of the world&rsquo;s leading biotechnology companies. We are global collaborators who achieve together&mdash;researching, manufacturing, and delivering ever-better products that reach over 10 million patients worldwide. It&rsquo;s time for a career you can be proud of. Join us.</li></ul><h2 class="jobSectionHeader">
Job purpose:</h2><ul><li> 
As a member of this fast-pace, complex and dynamic region, MEA Regulatory Affairs Senior Associate will be accountable for labeling and packaging activities management for Middle East North African region for Amgen portfolio for pipeline, inline and biosimilars; as well participating in labeling projects internally and externally for e-labeling implementation; and execution of Regulatory Affairs processes in the local office.</li></ul><h2 class="jobSectionHeader">
Job Responsibilities:</h2><ul><li>
Deliver both strategic and administrative system support for ongoing maintenance with Lifecyle management and updates to our existing platforms and systems, to ensure data standards are 100% accurate, as to enable effective reporting and data analytics</li><li>
Manage Performance Excellence through collection, analyzing &amp; disseminating relevant information to team(s) as appropriate</li><li>
Participate in local regulatory process improvements initiatives</li><li>
Build newsletter, annual Report, data analysis with follow up on Key Performance Indicators and Metrics</li><li>
Ensure delivery of right first time label source text for artwork creation</li><li>
Support efficiently the filing plan of different marketing application submissions and products life cycle management filings by providing regional product information (leaflet and SmPC) source texts and artworks in a timely manner</li><li>
Ensure implementation of master artworks as per Amgen procedures, SKU strategy and timelines with high quality to serve our patients in MENA region</li><li>
Access the translation agency systems to request the label translation and track the job readiness and timelines.</li><li>
Perform regional prescribing information translation review: 100% review of both content and format</li><li>
Perform the role of source text owner/approver and artwork reviewer/approver in the system</li><li>
Trigger the existing label revision when alerted by global RA team.</li><li>
Support in product launch and ensure supply continuity by creating and revising the commercial pack artworks (leaflet, label, blister, outer pack)</li><li>
Collate, distribute and exchange regulatory information with other regulatory colleagues and cross functional teams on an ongoing basis and provide advice on local regulatory considerations in a timely manner.</li></ul><h2 class="jobSectionHeader">
Qualifications:</h2><ul><li>
Experience +2 years in Regulatory Affairs</li><li>
Current/ previous experience in working as part of an MNC employer</li><li>
Pharmacist, biologist, chemist-medical background</li><li>
Fluent in English and Arabic for translation review purpose ( French is a huge plus)</li><li>
A minimum knowledge of Middle East Africa regulatory requirements</li><li>
Strong communication skills (verbal &amp; written) with ability to understand and communicate the scientific information and anticipate/prevent potential issues</li><li>
Conflict Management skillset &amp; ability to deal with multiple stakeholders simultaneously.</li></ul>
What You Can Expect Of Us 
 
As we work to develop treatments that take care of others, so we work to care for our teammates&rsquo; professional and personal growth and well-being.<ul><li> 
Vast opportunities to learn and move up and across our global organization</li><li>
Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act</li><li>
Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits</li></ul><h2 class="jobSectionHeader">
Apply now for a career that defies imagination 
 
In our quest to serve patients above all else, Amgen is the first to imagine, and the last to doubt. Join us. 
 
careers.amgen.com 
 
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, gender, sexual orientation, gender identity, national origin, protected veteran status, or disability status. 
 
We will ensure that individuals with disabilities are provided a reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request an accommodation.</h2></div>

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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