regulatory specialist

The Hawk Group

<div>
 
 
 Position Summary:
 
 
 
 The Regulatory Director leads and coordinates all regulatory permitting and stakeholder engagement activities for the Client project in Alaska. This role works with the engineering team to meet all federal, state, and local regulatory requirements, supporting timely project execution. The position serves as the key interface between the company, EPC contractors, and regulatory agencies.
 
 
 
 
 
 The ideal candidate brings extensive experience in LNG, oil &amp; gas, or large-scale infrastructure projects, with strong knowledge of federal (FERC, NEPA, MMPA, ESA, etc.), State of Alaska, and North Slope Borough regulatory processes. This position requires exceptional communication and coordination skills to manage complex multi-stakeholder interfaces effectively.
 
 
 
 
 
 
 Key Responsibilities
 
 
 <ul>
 <li>
 Lead the development and execution of the project permitting strategy.
 </li>
 <li>
 Manage contracted environmental consulting firm to successfully complete all elements of the FERC certificate process
 </li>
 <li>
 Identify, obtain, and manage all required environmental, safety, land use, construction, and operational permits.
 </li>
 <li>
 Represent the Owner in communications with federal, state, and local authorities (e.g., FERC, EPA, USACE).
 </li>
 <li>
 Assist HSE manager with understanding permit requirements and maintain compliance.
 </li>
 <li>
 Maintain the permitting register and provide regular status updates to project management.
 </li>
 <li>
 Manage regulatory risks and ensure adherence to environmental and safety regulations.
 </li>
 </ul>
 
 
 
 
 
 Qualifications &amp; Experience
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in environmental science, political science, or related discipline.
 </li>
 <li>
 Minimum 10 years&rsquo; experience in permitting and regulatory compliance for major energy, LNG, Oil &amp; Gas projects, with strong Alaska experience.
 </li>
 <li>
 Proven experience working in corporate structure with FEED process in parallel with regulatory process.
 </li>
 <li>
 Strong knowledge of Alaska regulatory framework and integration of an effective stakeholder plan and excellent communication and management skills.
 </li>
 <li>
 Demonstrated understanding of key ESA and MMPA issues for successful permitting of an offshore project in the Beaufort and Chukchi Seas of Alaska and effective mitigation measures that can be implemented to obtain all authorization&rsquo;s
 </li>
 <li>
 Excellent coordination, reporting, and stakeholder management skills.
 </li>
 </ul>
 
 
 
 
 
 Preferred Qualifications
 
 
 <ul>
 <li>
 Prior experience as an owner&rsquo;s representative or regulatory manager for large capital projects in Alaska.
 </li>
 <li>
 Direct LNG project experience.
 </li>
 <li>
 Strong relationships with Alaska state regulators and federal agencies.
 </li>
 <li>
 Background in environmental science, engineering, law, or a related field.
 </li>
 <li>
 Experience operating in remote or Arctic environments.
 </li>
 </ul>
 
 
 
 
 
 Key Competencies
 
 
 <ul>
 <li>
 Regulatory leadership and strategy
 </li>
 <li>
 Stakeholder and agency engagement
 </li>
 <li>
 Risk identification and mitigation
 </li>
 <li>
 Schedule and consultant management
 </li>
 <li>
 Clear decision‑making under pressure
 </li>
 <li>
 Alaska‑specific regulatory expertise
 </li>
 </ul>
 
 
</div>

Regulatory Specialist

Folio Clinical Research

Clinical Research Regulatory SpecialistRemote &ndash; U.S.-Based | Full-TimeAbout Folio Clinical ResearchFolio Clinical Research is a leading urologic research network treating urologic cancers, urinary stones, Peyronie's disease, sexual and erectile dysfunction (ED), low testosterone, prostate disorders, urinary incontinence, and more. We partner with leading physician practices to create a cohesive, quality-oriented clinical culture, facilitating best practice sharing across our platform. Our affiliated practices gain access to a broad suite of clinical trials, providing significant benefits to both physicians and patients.Position OverviewThe Regulatory Specialist is responsible for managing all regulatory documentation and ensuring that site-level trial activities comply with ICH/GCP guidelines, FDA and local regulations, and IRB requirements across Folio's clinical research sites. Working remotely in close partnership with Principal Investigators, CRC teams, and Regional Managers, this role owns the electronic Investigator Site File (eISF) and end-to-end regulatory processes from Site Qualification through Study Close-out.This role is a strong fit for an experienced CRC who has developed deep regulatory expertise and is ready to step into a dedicated regulatory function, or for a regulatory professional earlier in their career who wants focused ownership and a clear path to grow within a site network environment. If you are energized by documentation precision, audit readiness, and being the regulatory backbone of a high-performing research team &mdash; this role is for you.Key Responsibilities<ul><li>Manage all regulatory documentation in support of the PI/SI, APPs, research staff, and CRCs, ensuring compliance with ICH/GCP guidelines, FDA regulations, and IRB requirements.</li><li>Own the electronic Investigator Site File (eISF/eRegulatory) &mdash; maintaining completeness, accuracy, and audit-readiness throughout the trial lifecycle from Site Qualification to Study Close-out.</li><li>Prepare and submit IRB applications, amendments, continuing reviews, safety reports, and other required regulatory correspondence.</li><li>Maintain staff delegation logs, training records, CVs, medical licenses, and personnel documents for all site staff listed on study protocols.</li><li>Attend SQVs, SIVs, and interim monitoring visits (IMVs) remotely to ensure regulatory tasks are tracked, communicated, and resolved in a timely manner.</li><li>Lead preparation and follow-through for internal and external monitoring visits and audits; ensure all trial activities meet protocol, ICH/GCP, and SOP standards.</li><li>Lead training for site staff on regulatory requirements, documentation standards, and updated SOPs; ensure all personnel maintain current training records and certifications.</li><li>Partner with the CRC team and site leadership to align regulatory timelines with study startup, enrollment, and close-out milestones.</li><li>Identify regulatory risks and documentation gaps proactively; communicate findings to site leadership with recommended corrective actions.</li><li>Support the PI, CRCs, and Regional Managers with the overall growth of the clinical research program; define and achieve regulatory KPIs that drive company milestones while maintaining a culture of accountability.</li><li>Ensure adherence to GCP, Good Documentation Standards, ALCOA-C++, and IRB protocols and all applicable laws and policies governing the industry.</li></ul>QualificationsPlease note: This role requires experience in industry-sponsored clinical trials governed by FDA regulations. Candidates whose background is primarily in investigator-initiated trials, NIH-funded studies, or non-FDA-regulated academic research should note that this experience does not meet the requirements of this position.<ul><li>2&ndash;3 years of experience in a role where FDA-regulated, site-level regulatory coordination was a primary function &mdash; including hands-on responsibility for eISF/ISF management, IRB submissions, and sponsor/CRO-facing documentation on industry-sponsored pharma, biotech, or medical device clinical trials. General CRC experience where regulatory tasks were incidental to broader study coordination does not meet this requirement. Experience limited to investigator-initiated trials, NIH/academic research, or non-FDA-regulated studies does not qualify for this role.</li><li>Bachelor's degree or equivalent combination of education and experience in a science, health, or related field.</li><li>Working knowledge of ICH-GCP guidelines and FDA regulations (21 CFR Parts 11, 50, 56, 312) as they apply to industry-sponsored trials.</li><li>Demonstrated proficiency with eISF/eRegulatory systems; understanding of how site-level regulatory files interface with sponsor-side eTMF platforms during monitoring and audits.</li><li>Experience with a Clinical Trial Management System (CTMS); familiarity with CRIO a plus, as the regulatory team leads site-wide CRIO implementation.</li><li>Strong organizational, documentation, and communication skills; able to manage multiple concurrent studies and interface independently with sponsors, monitors, and IRBs.</li></ul>Preferred Qualifications<ul><li>Experience in a dedicated regulatory role at a clinical research site, SMO, central/independent IRB, or CRO site activation/startup function.</li><li>Experience in urology, oncology, or a related therapeutic area.</li><li>Medical device trial experience; familiarity with IDE regulations beneficial.</li><li>Certification in clinical research: CCRC, CCRP (ACRP or SOCRA), or equivalent.</li><li>Experience supporting FDA inspections or sponsor audits.</li></ul>Any data provided as a part of this application will be stored in accordance with our Policy.Folio Clinical Research is an Equal Opportunity Employer. Employment decisions are made without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status or other characteristics protected by law.Pay: $65,000.00 - $85,000.00 per yearBenefits:<ul><li>401(k)</li><li>Dental insurance</li><li>Employee assistance program</li><li>Flexible spending account</li><li>Health insurance</li><li>Health savings account</li><li>Life insurance</li><li>Paid time off</li><li>Vision insurance</li></ul>Education:<ul><li>Bachelor's (Preferred)</li></ul>Experience:<ul><li>clinical research regulatory or coordinating: 3 years (Preferred)</li><li>industry-sponsored (pharma/biotech/medical device) trials: 3 years (Preferred)</li></ul>Work Location: Remote

Clinical Research Regulatory Specialist

Semmes Murphey Foundation

<div>Description: The Semmes Murphey Foundation, affiliated with Semmes Murphey Clinic, is an independent, research-focused, public benefit corporation (501(c)3) dedicated to advancing innovation and excellence in neuroscience. We are growing our clinical research department and looking to add new talent to our team. 
This role provides our Foundation with critical regulatory support across various industry-sponsored clinical trials, PI-initiated and grant-funded studies, and quality registries. You will ensure regulatory compliance, timely IRB submissions, document control, and audit-ready study files throughout the lifecycle of clinical research projects.
Essential Duties and Responsibilities:<ul><li>
Prepare, submit, and track IRB applications for new studies, amendments, continuing reviews, and study closures</li><li>
Serve as a regulatory resource for investigators and research staff; assist with regulatory education and SOP adherence</li><li>
Facilitate contract and budget administration by coordinating IRB, sponsor organizations, physicians, outside counsel, and internal staff to keep projects on track</li><li>
Maintains regulatory binders and essential documents in compliance with FDA, CFR, ICH-GCP, HIPAA, and institutional policies</li><li>
Support internal audits, sponsor monitoring visits, and regulatory inspections; maintain audit-ready files</li><li>
Assist with data reporting, electronic data entry, and administrative study tasks as required by protocol</li><li>
Support quality initiatives and regulatory process improvements in collaboration with the Clinical Research Manager</li></ul>
Requirements:

MINIMUM:<ul><li>
Bachelor's degree in health sciences, life sciences, public health, healthcare administration, or related field</li><li>
Two or more years of clinical research experience; preferably with demonstrated regulatory and IRB submission responsibilities</li></ul>
PREFERRED:<ul><li>
Five plus years of clinical research regulatory experience</li><li>
Master's degree in related field</li><li>
Professional certifications such as CCRC (ACRP) or CCRP (SOCRA)</li><li>
Experience supporting multi-site or industry-sponsored clinical trials</li></ul>
Additional required skills include a working knowledge of FDA regulations (e.g. 21 CFR Parts 50, 54, 56, and 312/812 as applicable), the clinical trial process, and ICH-GCP guidelines. This role requires strong organizational skills and a high attention to detail. 
Equal Opportunity Employer/Veterans/Disabled
#SMF</div>

University of Southern California

<div>The University of Southern California (USC), founded in 1880, is the largest private employer in the City of Los Angeles. As an employee of USC, you will be a part of a world-class research university and a member of the &quot;Trojan Family,&quot; which is comprised of the faculty, students and staff that make the university what it is.
JOB ACCOUNTABILITIES:<ul><li>
Learns and masters the creation, initiation, development, and revision of protocols, informed consents, case report forms, and other study and clinical research documentation to support principal investigators and quality assurance systems for the Clinical Investigations Support Office. Submits protocols and supportingdocuments to internal and external regulatory bodies (i.e. Institutional Review Board), ensuring trials are consistent with approved proposals to open new studies.</li><li>
Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for CISO functions and research project goals. Manages and maintains CISO electronic regulatory files, including staff resumes, licenses, training certificates, equipment receipts, investigation logs, etc. Reviews documentation as needed to support regulatory filings, and maintains research files and documentation required by regulations.</li><li>
Works with senior team members to support and facilitate clinical research. Helps prepare and conduct high-quality compliance reviews, including close-out and reporting. Interacting with research investigators and staff throughout the process, from helping activate study and research trials to escalating problems and issues, as needed. Provides support and clinical-specific training to staff, maintaining and improving quality assurance training and development programs as needed.</li><li>
Updates all databases, and regulatory binders with information pertinent to studying milestone progress, including but not limited to: clinical trial management systems, IRB databases, internal and external spreadsheets, and study electronic systems.</li><li>
Ensures compliance with all applicable local, state, and federal regulations, statutes, and laws, and with agencies including the IRB and Federal Drug Administration (FDA). Maintains compliance with Good Clinical Practice (GCP) guidelines, patient confidentiality (HIPAA) and any other applicable laws.</li><li>
Maintains communication, attends meetings, and answers questions from all involved parties including regulatory bodies (i.e. IRB), pharmaceutical companies (including monitors), principal investigators and colleagues. Works with clinical trial coordinators, research staff and investigators to further communications, helping remove obstacles impeding trial progress.</li><li>
Participates in KSOM centralized activities to support and promote research regulatory requirements. Coordinates with and assists other CISO staff and departments with educational efforts, helping ensure highest quality research and protection of human subjects. Identifies compliance training and educational needs, coordinates the reporting of serious adverse events and protocol deviations, and proposes, completes, and submits amendments to protocols and trial forms and documentation, as needed.</li><li>
Performs other related duties as assigned or requested. The university reserves the right to add or change duties at any time.</li></ul>
Position location: On-site
Salary range:
The annual rate for this position is $75,968.95 - $101,364.43. When extending an offer of employment, the University of Southern California considers factors such as (but not limited to) the scope and responsibilities of the position, the candidate's work experience, education/training, key skills, internal peer equity, federal, state and local laws, contractual stipulations, grant funding, as well as external market and organizational considerations.
USC will consider for employment all qualified applicants with criminal records in a manner consistent with applicable laws and regulations, including the Los Angeles County Fair Chance Ordinance for employers and the Fair Chance Initiative for Hiring Ordinance, and with due consideration for patient and student safety. Please refer to the Background Screening Policy Appendix D for specific employment screen implications for the position for which you are applying. 

Minimum Education: Bachelor's degree Minimum Experience: 2 years/Combined education/experience as substitute for minimum experience Minimum Field of Expertise: Experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Experience with submissions to the Institutional Review Board and/or the Federal Drug Administration for Investigational Drugs and Devices (IND/IDE). Knowledgeable of Informational Conference on Harmonization-Good Clinical Practice (ICHGCP), Department of Health and Human Services (DHHS), Office of Human Research Protections (OHRP) and FDA regulations and procedures. Ability to evaluate the risks and benefits of different solutions, and proven problem-solving and decision-making skills to uncover causes of problems. Exemplary organization skills and attention to detail. Proven ability to interpret, analyze, and apply pertinent policies, procedures, regulations, and requirements. Deft interpersonal and diplomatic skills for communicating tactfully with all levels of staff and diverse individuals and groups. Demonstrated experience developing communication plans, instructional materials and related content. Experience with office management communication software/tools (e.g. Google suite, Slack, Skype). Preferred Education: Bachelor's degree Preferred Experience: Three years Supervises: No Preferred Field of Expertise: Three years&rsquo; experience in clinical research compliance, regulatory research and/or operations in the academic or private sector. Extensive experience in compliance oversight, coordination, monitoring, and/or auditing of clinical research studies and trials. Advanced knowledge of regulations governing human research. Special Instructions to Applicants: Applicant Attachments (Required): R&eacute;sum&eacute; &amp; Cover Letter Applicant Questions: N/A Learns and masters the creation, initiation, development, and revision of protocols, informed consents, case report forms, and other study and clinical research documentation to support principal investigators and quality assurance systems for the Clinical Investigations Support Office. Provides regulatory affairs support, coordinating or performing a wide variety of administrative and data management activities for CISO functions and research project goals. Helps prepare and conduct high-quality compliance reviews, including close-out and reporting. Updates all databases, and regulatory binders with information pertinent to studying milestone progress. Maintains communication, attends meetings, and answers questions from all involved parties including regulatory bodies, pharmaceutical companies, principal investigators and colleagues.</div>

The Lebermuth Company

<div>Description:

Summary:
As the Regulatory Specialist, you will assist the Regulatory team with ensuring Lebermuth maintains compliance with all applicable governmental, international and industry regulations in the manufacture and/or sale of Company products.
Essential Duties &amp; Responsibilities:<ul><li>
Supports purchasing in the vendor approval process by collecting, reviewing and maintaining documents for new and current raw material suppliers.</li><li>
Coordinates and communicates with the Purchasing, R&amp;D and QA, QC departments for the completion of new or alternate vendor reviews and raw material supplier data as needed.</li><li>
Coordinates, prepares and submits regulatory documents to customers and other external parties in a timely manner.</li><li>
Maintains current knowledge of existing and emerging regulations, standards and guidance documents (IFRA, Cosmetics, Kosher, Organic, Fair Trade, Leaping Bunny, etc.) to ensure Lebermuth can continually produce exceptional products for our customers.</li><li>
Collects and maintains all supplier documents to ensure raw material composition &amp; technical data is up to data in our systems.</li><li>
Prepares and maintains technical files, SOP&rsquo;s and participates in audits, as necessary, to obtain approval and sustain production.</li><li>
Promotes a safe food culture by maintaining a clean and organized workspace and accurately completing Lebermuth required paperwork (i.e., equipment logs, regulatory documentation) to ensure the safe production and shipment of quality food products.</li><li>
The job criteria may include other duties, responsibilities, and activities, which may change or be assigned at any time with or without notice.</li></ul>
Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requirements:

Education: Bachelor&rsquo;s degree in a science-related discipline is preferred.
Experience: 2 + years of on-the-job experience. Without a degree, 2+ years of on-the-job regulatory or related field experience is acceptable. Knowledge of Organic Chemistry is a plus. Flavor, Fragrance, and/or Chemical industry experience preferred. Knowledge of SQF, cGMP, and HACCP programs a plus. Knowledge of regulations in DEA, DOT, and FDA a plus.
Certifications: N/A
Functional Skills: Ability to apply mathematical concepts such as fractions, percentages, dosages, proportions, and volume. Ability to solve complex problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. Integrates complex or diverse information; uses intuition and experience to complement data; designs workflows and procedures; prioritizes and plans work activities; uses time efficiently; sets goals and objectives; demonstrates accuracy and thoroughness; looks for ways to improve and promote quality; applies feedback to improve performance.
Technology Aptitude/Skills: Strong working knowledge and experience with MRP/ERP systems and familiarity with regulatory-related programs is a plus. Proficiency with Microsoft Office products, particularly Excel and Word are necessary.
Language Skills: Solid verbal communication skills. Ability to read, analyze and interpret professional journals, technical procedures, governmental regulations, and chemical hazard information and safety procedures. Ability to write correspondence that is professional in both content and tone. Ability to effectively present information and respond to questions.
Leadership/Behaviors Skills: Displays original thinking and creativity; meets challenges with resourcefulness; generates suggestions for improving work; develops project plans; communicates changes and progress; completes projects on time and on budget; balances team and individual responsibilities; exhibits objectivity and openness to others' views; able to build morale and group commitment to goals and objectives; Treats others with respect and consideration, regardless of their status or position; reacts well under pressure; accepts responsibility for own actions; follows through on commitments; observes quality, safety and security procedures; determines appropriate action beyond guidelines; reports potentially unsafe conditions.
Culture Match Behaviors: Enjoys and thrives in a fast-paced, high-growth environment, with a huge drive to create an impact while also being an effective listener, respectful problem-solver, and a collaborative continuous learning team member.
Physical and Sensory Demands / Environmental Conditions / Equipment Used:<ul><li>
This role routinely uses standard office equipment such as computers, phones, electronic devices, photocopiers, filing systems/cabinets and fax machines.</li><li>
Ability to sit at desk for 6+ hours per day.</li><li>
Ability to operate keyboard and view computer screen frequently.</li><li>
Ability to write ideas/information in a logical flow.</li><li>
Cognitive and reasoning ability to frequently read, review and interpret regulatory documents, work orders or processes.</li><li>
Ability to read and respond based on business need and respond in a timely manner.</li><li>
Ability to prioritize workload based on business need and the ability to adjust priorities as work objectives change.</li><li>
Ability to talk and communicate with others via phone, in-person, and/or computer frequently.</li><li>
Ability to listen to vendors and internal customers, problem-solve, and respond accordingly.</li><li>
Ability to think and work independently or with a cross functional team as needed to complete assignments.</li><li>
Lifting and/or moving of 15lbs sporadically.</li><li>
The employee is primarily exposed to a normal office environment with moderate noise.</li><li>
The employee is occasionally required to wear suitable Personal Protective Equipment while visiting Operations areas.</li><li>
While performing the duties of this job, the employee is regularly exposed to perfumes and airborne particles.</li><li>
Approximately 20% travel, including day trip and overnight, utilizing various modes of transportation. Remote workers are expected to visit the corporate office multiple times per year and/or as needed.</li><li>
The work schedule is generally 8-5pm Monday &ndash; Friday but may vary (to include evenings and/or weekends) due to travel requirements and business needs.</li></ul> 
Reports to: Regulatory Director
FLSA Status: Exempt</div>

Regulatory Specialist - Supply Chain Support

POS Enterprise

<div>
 
 
 Job Title:
 
 Regulatory Affairs Specialist
 
 
 
 Company:
 
 POS Enterprise
 
 
 
 Location:
 
 Egypt (with flexibility to travel internationally)
 
 
 
 Job Summary:
 
 
 
 We are seeking an experienced Regulatory Affairs Specialist with over 5 years of experience in medical devices. The ideal candidate will have a strong background in registering products both within Egypt, internationally and the ability to manage regulatory processes efficiently across multiple markets. This role requires excellent knowledge of local and global regulatory requirements, along with a proactive approach to ensuring compliance and timely product approvals.
 
 
 
 
 
 
 Key Responsibilities:
 
 
 <ul>
 <li>
 Manage and oversee regulatory submissions for medical devices in Egypt and international markets.
 </li>
 <li>
 Prepare, review and submit registration dossiers in compliance with local and global regulatory requirements.
 </li>
 <li>
 Liaise with regulatory authorities to ensure timely approvals and address any queries or deficiencies.
 </li>
 <li>
 Maintain and update product registrations, including variations, renewals and post-marketing requirements.
 </li>
 <li>
 Ensure compliance with applicable laws, guidelines and standards.
 </li>
 <li>
 Coordinate with internal departments (quality, production, marketing) to gather necessary documentation.
 </li>
 <li>
 Monitor changes in regulatory regulations and communicate impacts to the business.
 </li>
 <li>
 Support product lifecycle management and regulatory strategy planning.
 </li>
 </ul>
 
 
 
 
 
 Qualifications &amp; Requirements:
 
 
 <ul>
 <li>
 Bachelor&rsquo;s degree in Pharmacy, Medicine, or a related field.
 </li>
 <li>
 Minimum of 5 years of experience in Regulatory Affairs within the medical device industry.
 </li>
 <li>
 Proven experience in registering products in Egypt and other international markets.
 </li>
 <li>
 Strong knowledge of Egyptian Drug Authority (EDA) regulations and international regulatory frameworks.
 </li>
 <li>
 Excellent documentation and dossier preparation skills.
 </li>
 <li>
 Strong communication and organizational skills.
 </li>
 <li>
 Ability to work independently and manage multiple projects simultaneously.
 </li>
 <li>
 Willingness and ability to travel when required.
 </li>
 </ul>
 
 
 
 
 
 Preferred Skills:
 
 
 <ul>
 <li>
 Experience with
 
 medical devices, including CGM (Continuous Glucose Monitoring), is a plus
 
 .
 </li>
 <li>
 Familiarity with CTD/eCTD formats.
 </li>
 </ul>
 
 
</div>

Regulatory Affairs Specialist

EVA pharma

<div>
 
 Join EVA Pharma, a leading pharmaceutical company dedicated to empowering the fight for Health and well-being as a fundamental human right. Recognized and certified as a best place to work, we are committed to fostering a supportive and innovative environment for our team members.
 
 &nbsp;
 
 
 
 Job Summary:
 
 
 
 We are seeking a passionate and talented
 
 Regulatory Affairs Specialist
 
 to join our dynamic team.
 
 
 The ideal candidate will contribute to our mission of enhancing human health and well-being, ensuring that we meet the highest standards of excellence in our industry.
 
 
 
 
 
 Key Responsibilities:
 
 
 
 
 <ul>
 <li>
 Regulatory Compliance - Ensure all products meet international regulations, serving as the primary regulatory contact for our international hubs
 </li>
 <li>
 Product Registration - Prepare, submit, and manage dossiers for new drugs, renewals, and variations, guiding approvals from start to finish
 </li>
 <li>
 Compliance Monitoring - Stay ahead of evolving regulations, advising internal teams on critical updates to maintain full compliance
 </li>
 <li>
 Labeling &amp; Packaging Review - Ensure all pharma labeling, packaging, and promotional materials adhere to regulatory standards
 </li>
 <li>
 Cross-Functional Collaboration - Partner with R&amp;D, QA, Manufacturing, and Marketing to embed regulatory requirements at every stage
 
 </li>
 </ul>
 
 
 Qualifications:
 
 
 
 
 <ul>
 <li>
 Bachelor's degree in Pharmaceutical Sciences
 </li>
 <li>
 +2 years of experience in Regulatory Affairs in international Markets.
 </li>
 <li>
 Fluent in English (written &amp; verbal) - essential for global collaboration
 </li>
 <li>
 Detail-oriented, proactive, and eager to grow in a dynamic regulatory landscape
 </li>
 </ul>
 
 
</div>

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