Trumbull, United States
over 1 year ago
Lighthouse Professional Services, a division of Staffing 360 Solutions group of companies, has been providing contract and direct hire talent to client companies, ranging from small businesses to Fortune 500 corporations for over 50 years. Our offices are in New York, Connecticut, and Massachusetts, and we work with clients across the country. Our management and recruiting teams are led by experienced industry professionals. We invest in excellent working partnerships, powered by people.
We are currently seeking a Regulatory Affairs Manager -Pharma in Trumbull, CT and can be a Remote Position.
Position Summary and Special Duties:
As a (an) Regulatory Affairs Manager your day-to-day duties will consist of and may not be limited to: The Regulatory Affairs Manager, Pharma is responsible for overseeing management all regulatory activities associated with the Company’s key Pharmaceutical product. This position will oversee the preparation, and submission of all regulatory submissions to FDA’s FDA Office of Prescription Drug Promotion (OPDP) as well as to communicate status to all appropriate departments.
- As this position is remote to the facility location, the candidate must be available during business hours for the US Eastern Time Zone and must have sufficient technological ability to conduct business over voice/video/and electronic communications.
- Responsible for all aspects of regulatory submissions for an established pharmaceutical product, including major New Drug Application Supplements in electronic format per the eCTD requirements, and submissions to the FDA Office of Prescription Drug Promotion (OPDP), and other communications, as necessary.
- Serves as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of prescription pharmaceutical products.
- Maintains a thorough understanding of OPDP requirements as well as a keen awareness of enforcement trends.
- Responsible for the creation, and submission of new Advertisement and promotional materials to FDA’s OPDP office.
- Support the Pharmacovigilance activities to ensure compliance.
- Review of Adverse Events for reportability and completing and submitting reports for Adverse Events globally as necessary.
- Conducts a detailed review and evaluation of the adequacy of clinical evidence provided to support proposed claims, assesses consistency of proposed claims with FDA approved labeling and delivers consistent, well-supported, and clear guidance on claims.
- Manage interactions with other functions (e.g., Quality, Medical, Legal, etc.) to ensure compliance with regulatory requirements for day-to-day operation.
- Provides support to Quality Audits (Internal or by Regulatory Authority).
- Ensure that labeling complies with all applicable regulations and guidelines.
- Participate in the review of process/product changes, labeling, claims, complaints, etc.
- 8 + years relevant pharmaceutical industry and regulatory experience
- Bachelor’s degree in science or health related field. Advanced degree preferred.
- Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations.
- Specific experience and management of the FDA OPDP process.
- Experience in Pharmacovigilance and the review and submission of Pharmaceutical Adverse Events to Regulatory agency.
- Strong knowledge of FDA regulations applicable to Pharmaceuticals, esp. 21CFR Parts 210, 211 and 800 as appropriate.
- Understanding of regulations of Medical Device/drug combination products regulation is a plus.
- Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses.
- Demonstrated experience with health authority submissions, i.e., authored, reviewed, or managed an original or supplemental application (IND, NDA, ANDA, Supplements, etc.,).
- Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities.
- Ability to influence and partner with cross-functional teams in a pharmaceutical organization.
- Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported by data.
- Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks.
- Duration: DIRECT HIRE
- Location: REMOTE OR Trumbull, CT.
- Salary: 115-130K
- Benefits: yes
- Shift: Office: 8:30AM- 5PM
Qualified candidates are encouraged to apply immediately!
Please include a clean copy of your resume and salary expectations and any references.