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The position of Associate, Regulatory Affairs-CMC will provide Chemistry, Manufacturing, and Controls (CMC) support for all current products on the US market as well as products currently in development.
• Provide CMC Regulatory support as needed through the authoring/co-authoring/review of CMC sections of the following types of Regulatory submissions:
- NDA Original Submissions;
- NDA Supplements;
- NDA Annual Reports;
- IND Amendments and Annual Reports;
- 510(k) submissions for medical devices
• Provide CMC Regulatory support as needed for the authoring/co-authoring/review of documents related to all OTC drugs marketed in the US under the FDA Monographs.
• Attend meetings for assigned projects, as needed, to provide Regulatory perspective/oversight and ensure products are developed and manufactured in accordance with cGMP and all applicable US regulations.
• Collaborate with R&D and other cross-functional partners to support compliant execution of change management via the review of CMC-related change documentation.
• Assess and communicate potential CMC Regulatory risks to products and/or projects and propose mitigation strategies;
• Deliver all CMC Regulatory milestones for assigned products across the product lifecycle;
• Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the RB to ensure approval and product supply continuity;
• Identify, communicate and escalate potential CMC Regulatory issues to Regulatory Management, as needed;
• Monitor the US Regulatory environment, gather any CMC-related technical information and work with the CMC Regulatory Manager/US Regulatory RB procedures;
• BS or BA, minimum
• Graduate degree a plus
• Minimum of 3-5 years of pharmaceutical OTC or Rx regulatory affairs CMC experience
• Strong working knowledge of US CMC regulations and guidelines applicable to OTC drugs including NDA and IND compilation and filing requirements and Monograph products
• Strong working knowledge of current Good Manufacturing Practices (cGMP)
• Strong working knowledge of Quality sections of the Common Technical Document (CTD) submission structure
• Good working knowledge of the electronic CTD (eCTD)
• Experience with compiling CMC sections of NDAs in eCTD format and submission to FDA via the Electronic Submission Gateway (ESG)
• Working knowledge of device 510(k) CMC-related requirements desirable.
• Good oral and written communication skills along with demonstrated team skills
• Capable of preparing and presenting effective technical reports and analyses
• Proficient in Microsoft Word, PowerPoint, Excel, Access and Project. Fluent in working with PDF documents. Experience with Documentum a plus.
• Excellent organizational skills
• Demonstrated oral and written communication skills in multicultural settings and ability to understand and communicate complex issues in a succinct and logical manner.
• Understands related fields (e.g., manufacturing, analytical, quality assurance).
• Ability to prioritize and resolve complex issues
• Willing to work in a dynamic, fast paced environment
• Excellent interpersonal skills and the ability to interact comfortably/competently with all levels of management, both internally and externally
• Ability to work independently and demonstrate high level of initiative
• Ability to manage multiple tasks simultaneously
• Excellent problem-solving skills
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