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Regulatory Affairs Manager
2 months ago
Job Summary:
The Regulatory Affairs Manager will be responsible for the generation, revision, submission, supervision, and critical review and approval of pre- and post-approval NDA 505(b)(2) labeling. This role will lead Generic Product Working Group (gPWG) meetings with appropriate stakeholders when establishing or revising labeling.
Key Responsibilities:
- Assist in the review of Gx labeling documents filed under an ANDA while adhering to federal regulations and internal processes and meeting deadlines driven by company goals.
- Oversee any/all team databases and trackers and accurately update them when changes are required.
- Provide direction to direct reports for projects assigned and assure that all required FDA reporting obligations are met in accordance with business objectives and regulations.
- Communicate, plan, prioritize, and perform training to ensure labeling documents prepared align with company goals, submission requirements, legal, and regulatory requirements.
- Perform in-depth quality reviews of labeling and submission documents prior to final disposition to the agency.
- Work with Regulatory Operations to ensure assigned projects are submitted on-time following the eCTD requirements related to labeling.
- Collaborate with external departments/sites, including PV, IP, Marketing, CMC, and Device team(s), to align with product/device strategy.
- Attend meetings, train and develop respective team members, and write, revise, and/or train on SOPs/WIs as appropriate.
- Maintain a metric of all team projects for reporting purposes.
- Maintain knowledge of US regulations, guidelines, and SOPs applicable to US labeling.
Requirements:
- Msc/MPharm/BPharm with a Scientific or Regulatory background or equivalent combination of education and experience.
- Total years of experience required for the role: 6 to 7 years of US labeling experience, with a focus on NDA 505(b)(2) applications + 1 year supervisory experience.
- Relevant years of experience: 6 to 7 years Pharmaceutical industry experience required, specifically in Regulatory Affairs and US NDA 505(b)(2)/ANDA.
- Ability to multi-task in a fast-paced work environment, with exemplary oral and written communication skills.
- Organized with a keen attention to detail, with the ability to work independently as well as in a team environment.
- Thorough understanding of FDA US regulations and guidances related to US NDA/ANDA labeling.
- Knowledge of FDA eCTD submission.
- Ability to establish and maintain good working relationships within the company and with external contacts.
- Proficient knowledge of SPL development and FDA drug listing requirements.
- PC, Microsoft Office Suite with a proficiency in Microsoft Word and Microsoft Excel, Adobe Acrobat Professional, and familiarity with TVT and Intagras SPL portal.
