Job Title: Senior Associate, Regulatory Affairs
Location: Morristown, New Jersey
About the Role:
We are seeking a highly motivated and detail-oriented Senior Associate, Regulatory Affairs to join our team. In this role, you will help author, compile, review, and submit high-quality regulatory submissions to the FDA within company timelines and in accordance with regulatory guidelines and applicable federal laws. You will also coordinate and write clear, concise, and accurate responses to inquiries from the FDA.
Key Responsibilities:
- Interact effectively with functional business units to coordinate and facilitate the procurement of documentation required for submissions.
- Review technical documents for accuracy and determine their acceptability for use in new NDAs, Amendments, Supplements, Annual Reports, and other required FDA filings.
- Compile high-quality, original new NDAs (505(b)(1) and 505(b)(2)), Amendments, Supplements, and Annual Reports.
- Assess changes and their impact on the business based on an understanding of regulatory guidelines and applicable federal laws.
- Track and maintain various regulatory spreadsheets and databases.
- Answer and keep a record of any departmental phone calls from regulatory agencies and notify appropriate personnel.
- Perform other duties as assigned.
Qualifications:
- Minimum of a Bachelor's Degree in a life science.
- Minimum of 3 years in the pharmaceutical industry with 1-2 of those years in regulatory affairs.
- Excellent verbal and written communication skills.
- Knowledge and understanding of FDA guidelines.
- Strong critical and logical thinking skills with the ability to analyze problems and recommend solutions.
- Ability to prioritize competing tasks in a fast-paced and dynamic environment.
- Highly motivated, results-driven with a strong attention to detail, accuracy, and clarity.
