Regulatory Affairs Manager

3 weeks ago


Cary, United States Compass Consulting Full time
Our client is a pharmaceutical company focused on developing and promoting products in the rare disease markets.

Main Responsibilities:
Regulatory Affairs Strategy and Management:
  • Participate in R&D Core Teams (CTs) and Global Regulatory Teams (GRTs).
  • Oversee annual budgeting for regulatory activities and manage activities against approved budget.
  • Organize and lead cross functional Regulatory sub teams to meet business objectives.
  • Counsel and advise on regulatory procedures consistent with disease area and available guidelines.
  • Develop and manage multiple and possibly conflicting complex projects, timelines, and objectives within a matrix team environment.
  • Provide detailed review of project documents to ensure technical accuracy and compliance with regulatory requirements.
  • Serve as FDA point of contact for assigned assets.
  • Provide leadership and planning for meetings with FDA.
  • Contribute regulatory perspective due diligence evaluations of potential acquisitions and partnerships.
  • Provide knowledgeable support to the production and management of product labelling, promotional material, and risk mitigation strategies.
  • Support regulatory compliance of clinical trials by providing guidance on applicable regulations and FDA/ICH guidelines and standards.
  • Compile comprehensive scientific information for use in regulatory submissions.
  • Manage and lead the preparation and review of US regulatory applications, reports, and correspondence in a manner that ensures timeliness, accuracy, comprehensiveness, and compliance with internal and external regulatory standards.
  • Act as point of contact and primary regulatory resource for internal and external technical file (e.g., IND, NDA, BLA, etc.) audits.
  • Ensure maintenance of technical files as necessary to obtain and sustain product approval.
  • Performs other related duties as assigned.
Regulatory Affairs Information and Intelligence:
  • Maintains current knowledge of relevant regulations, including proposed and final rules.
  • Evaluates impact and analyses trends of FDA regulatory developments and interprets essential elements for impact on strategic regulatory decisions.
  • Monitor competitor products and their submission outcomes for potential impact on the regulatory strategy.
  • Manage, promote, and circulate relevant regulatory information on projects/products applicable to the R&D pipeline by means of meetings, databases, and/or intranet.
  • Recommend changes to company procedures in response to changes in regulations or standards.?


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