What are the responsibilities and job description for the Senior Manager / Associate Director - Regulatory Affairs - Onsite, Nashville (Relocation Package Available) position at Meet?
Company Overview :
A leading pharmaceutical company with a strong commitment to patient care and innovation is seeking an Associate Director, Regulatory Affairs. The organization focuses on delivering high-quality prescription medicines, particularly in underserved niche markets such as hospital acute care and gastroenterology. Their mission is to provide innovative products that address unmet medical needs while maintaining compliance with regulatory requirements.
Position Overview :
The Associate Director, Regulatory Affairs will assist in managing regulatory activities, including the design and execution of clinical studies and the preparation of pre-approval and post-approval regulatory submissions. This role is critical in ensuring regulatory compliance and supporting product development efforts.
Key Responsibilities :
- Prepare and review a variety of regulatory documents, including NDAs, INDs, and related amendments and supplements.
- Oversee the preparation and review of annual reports for both approved and investigational products.
- Collaborate within a cross-functional team to achieve corporate regulatory objectives.
- Develop and implement regulatory strategies to support successful approval of submissions.
- Manage regulatory activities for key projects and coordinate department efforts related to filings.
- Provide expert guidance on clinical trial design, execution, and reporting across all phases of development.
- Contribute to a positive organizational culture by fostering values centered around patient care, scientific advancement, and teamwork.
- Ensure compliance with U.S. and international regulatory requirements.
- Collaborates with various internal departments and stakeholders.
- Engages with regulatory agencies, vendors, and external partners as necessary.
Qualifications & Requirements :
