Regulatory Affairs Manager
THE RITEDOSE CORPORATION•Columbia, SC
•Onsite
About The Position
The Regulatory Affairs Manager supports the development and execution of regulatory strategies for ANDA submissions and CDMO support for customer-led FDA and global submissions. The role ensures compliance with regulatory requirements and manages lifecycle activities in alignment with the Director of Regulatory Affairs. Candidates must live in or be willing to relocate to South Carolina, Alabama, Florida, Illinois, or Missouri.
Requirements
- Bachelor of Science in Biology, Chemistry, Engineering, Pharmaceutical Sciences, or a related field.
- At least 5 years of Regulatory Affairs experience.
- Experience submitting NDA/ANDAs to the US FDA, including writing and compiling eCTD-compliant Modules 1, 2, and 3.
- Strong attention to detail, problem-solving skills, and organizational skills.
- Ability to work on complex projects, take initiative, and work with general direction and minimal guidance.
- Ability to adapt to changing priorities.
- Excellent written, verbal, and listening skills, and ability to work well with others.
- Experience using an electronic document control system.
- Proficiency with Microsoft Word, Excel, PowerPoint, and Adobe Acrobat.
Nice To Haves
- Experience with device and/or drug/device combination products.
- Experience with eCTD publishing software.
Responsibilities
- Write and edit technical documents for internal ANDA projects and customer-led global submissions.
- Serve as the primary regulatory affairs contact on project teams supporting product development.
- Format, publish, and submit documentation to the FDA for initial and lifecycle submissions.
- Respond to FDA queries and deficiencies.
- Provide guidance to Regulatory Affairs Specialists and help develop the team.
- Develop and implement regulatory strategies for product development, registration, and maintenance across assigned markets.
- Monitor and interpret new and evolving regulations and assess their impact on company products.
- Draft, review, and finalize product labeling for ANDA submissions, including structured product labeling.
- Oversee the adverse event reporting process and ensure compliance with reporting requirements.
- Support due diligence activities, licensing, and partnerships.
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What This Job Offers
Job Type
Full-time
Career Level
Manager
