About this role
Job Description:
The Regulatory Affairs Manager is responsible for supporting development and execution of regulatory strategies for ANDA submissions as well as CDMO support for customer-led submissions (FDA and global). The Regulatory Affairs Manager will ensure compliance with regulatory requirements and manage lifecycle activities in alignment with the Director of Regulatory Affairs.
***We will only consider candidates that either live in or will relocate to one of the following states: SC, AL, FL, IL, MO
Responsibilities:
Provide critical support in writing and editing technical documents to support submissions for internal ANDA projects as well as customer-led global submissions.
Serve as primary RA contact on project teams to support product development.
Format, publish, and submit documentation to the FDA for initial and lifecycle submissions.
Respond to FDA queries and deficiencies.
Provide guidance to RA Specialists and aid in development of team.
Develop and implement regulatory strategies for product development, registration, and maintenance across assigned markets.
Monitor and interpret new and evolving regulations and assess impact on company products.
Draft, review, and finalize product labeling for ANDA submissions, including structured product labeling.
Oversee adverse event reporting process and ensure compliance with reporting requirements.
Support due diligence activities, licensing, and partnerships.
Qualifications:
Bachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field
5+ years Regulatory Affairs experience
Experience submitting NDA/ANDAs to US FDA required, including writing and compiling eCTD compliant Modules 1, 2, and 3
Highly detail-oriented and possess considerable problem-solving and organization skills
Ability to work on complex projects and take initiative with general direction and minimal guidance
Ability to be flexible with a change in priorities
Excellent written, verbal, and listening skills, must work well with others
Experience using an electronic document control system
Experience with publishing using eCTD publishing software preferred
Proficient with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat
Qualifications
- Bachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or related field
- 5+ years regulatory affairs experience; FDA submission experience required, experience with device and/or drug/device combination products preferred
- Highly detail-oriented and possess considerable problem-solving and organization skills
- Ability to work on complex projects and take initiative with general direction and minimal guidance
- Ability to be flexible with a change in priorities
- Excellent written, verbal, and listening skills, must work well with others
- Experience using an electronic document control system
- Experience with eCTD publishing software preferred
- Proficient with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat