Specialist, Regulatory Affairs - CMC - Remote
Job Summary: We are looking for a Specialist, Regulatory Affairs - CMC to join our Regulatory team. The position is responsible for the Regulatory Affairs activities (nonclinical, clinical and CMC) for assigned commercial and investigational development products from preclinical candidate designation through product approval, including regulatory submissions.
- Reporting to: VP, Regulatory Affairs
- Location: Remote, candidate must be in Eastern Standard Time or Central Standard Time
- Salary Range: *$65,000-$75,000 + annual bonus
- the final salary offered will depend upon factors that may include but are not limited to the quality and length of experience, education and geographic location.
Responsibilities & Essential Duties:
- Serves as regulatory CMC representative on project teams to ensure that development activities support and comply with the relevant regulatory requirements.
- Reviews proposed CMC changes and assesses regulatory impact and filing requirements.
- Supports the preparation, submission, and management of regulatory filings (INDs, CTAs, BLAs, etc.) to health authorities.
- Collaborates on submission content with contributing authors across functional areas to achieve clarity and regulatory compliance (INDs, CTAs, BLAs/NDAs, meeting packages, responses, supplements, annual reports).
- Ensures timely preparation of organized and scientifically valid applications.
- Contributes to the development of internal regulatory CMC guidance and SOPs.
- Reviews/contributes to product development plans for assigned submissions/products.
- Interacts with regulatory agencies on defined matters.
- Responsible for executing regulatory documentation infrastructure, including paper and electronic submissions.
- May be required to travel up to 15%.
Basic Qualifications:
- Minimum of a Bachelor's degree in Chemistry, Biolog