About the Company
Perrigo Company plc is a leading global consumer self-care company, committed to making lives better by bringing ‘Quality, Affordable Self-Care Products’ that people can trust. With a rich history spanning over a century, Perrigo develops, manufactures, and markets a diverse portfolio of over-the-counter (OTC) health and wellness products across various categories including analgesics, digestive health, cough/cold, and nutritional products. Operating across North America, Europe, and Australia, Perrigo is dedicated to consumer well-being and maintaining the highest standards of product safety and regulatory compliance worldwide.
Job Description
We are seeking a highly skilled and experienced Senior Regulatory Affairs Chemist with a strong focus on global compliance to join our dynamic team in New Port Richey, Florida. This pivotal role involves ensuring that all our consumer self-care products meet global regulatory requirements throughout their lifecycle. The successful candidate will be instrumental in navigating complex international regulations, preparing and managing regulatory submissions, and providing expert guidance to cross-functional teams. You will leverage your comprehensive understanding of chemical compositions, manufacturing processes, and global regulatory frameworks to drive successful product registrations and market access. This position demands meticulous attention to detail, proactive problem-solving, and a commitment to upholding the highest standards of quality and compliance in the consumer health industry.
Key Responsibilities
- Lead the preparation, submission, and maintenance of global regulatory dossiers for new and existing products, ensuring timely approvals.
- Interpret and apply complex international regulatory guidelines (e.g., FDA, EMA, Health Canada, TGA) related to chemical ingredients, product formulations, and manufacturing processes.
- Collaborate closely with R&D, Quality Assurance, Manufacturing, and Legal departments to ensure all product development and production activities comply with global regulatory standards.
- Conduct regulatory impact assessments for product changes, deviations, and non-conformances, providing strategic recommendations.
- Participate in and support internal and external audits, including responses to regulatory agency inquiries.
- Monitor global regulatory landscape changes, assess their impact on existing and pipeline products, and proactively implement necessary adjustments to compliance strategies.
- Develop and deliver training sessions to internal teams on regulatory requirements and best practices.
- Manage regulatory databases and documentation systems to ensure accuracy, integrity, and accessibility of all regulatory records.
Required Skills
- Bachelor's degree in Chemistry, Biochemistry, Pharmaceutical Sciences, or a related scientific field.
- Minimum of 5 years of progressive experience in regulatory affairs within the pharmaceutical, consumer health, or specialty chemical industry, with a focus on global compliance.
- In-depth knowledge of global regulatory requirements and guidelines (e.g., FDA, EMA, Health Canada, TGA) for product registration and lifecycle management, specifically pertaining to chemical composition.
- Demonstrated experience in preparing and submitting regulatory dossiers (e.g., CTD/eCTD, IND, NDA, ANDA, OTC monographs, Cosmetics registrations).
- Strong analytical skills with the ability to interpret scientific data and regulatory texts.
- Excellent written and verbal communication skills for effective interaction with regulatory agencies and internal stakeholders.
- Proficiency in regulatory information management systems and Microsoft Office Suite.
Preferred Qualifications
- Master's degree or Ph.D. in Chemistry, Pharmaceutical Sciences, or a related field.
- Regulatory Affairs Certification (RAC).
- Experience with specific regulatory software platforms (e.g., Veeva, Sparta Systems).
- Project management experience in a regulatory setting.
- Familiarity with GxP regulations (GMP, GLP, GCP).
Perks & Benefits
- Comprehensive medical, dental, and vision insurance plans.
- 401(k) retirement plan with company match.
- Generous paid time off (PTO) and company holidays.
- Opportunities for professional development and continuing education.
- Life and disability insurance.
- Employee wellness programs.
- Tuition reimbursement.
- Employee assistance program (EAP).
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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