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Regulatory Affairs Manager

Cary, NC 27518 | Work from home flexibility

Posted: 12/28/2023 Employment Type: Direct Hire Industry: Quality and Regulatory Affairs Job Number: 11348 Pay Rate: $140k - $150k

Job Description

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.?

Job Requirements

Experience Required:
  • Experience in the Pharmaceutical industry: 8+ years
  • Direct Pharma Regulatory experience: 5+ years
  • In-depth knowledge of the full drug development process inclusive of direct experience with FDA meetings and submissions for new drugs and biologics performed in accordance with US/FDA laws and regulatory procedures.
  • Proficiency in reading and interpreting regulatory guidance documents and initiating changes in systems to ensure regulatory compliance.
  • Understanding of US federal regulations and processes related to the development of drugs and filing of an application.
  • Demonstrated proficiency in written, verbal, and face-to-face communication skills with ability to effectively present information and influence decision making of working partners (local and global) and government agencies.
  • Proven ability to manage multiple tasks and multifunctional resources concurrently and to respond to rapidly changing priorities and aggressive deadlines.
  • Expertise in technology systems utilized for electronic documentation, including but not limited to: Microsoft Office, Acrobat Professional, eCTD Viewer.
  • BS/BA in Chemistry, Pharmacy, or Biologic Science. Regulatory Affairs Certification preferred.

Meet Your Recruiter

Steve Butters
Director of Business Development, East Coast

As the Director of Business Development on the East Coast, Steve is a crucial part of expanding Compass's reach in the biotech space. Steve enjoys partnering with clients who want to make a difference in the world of medicine, curing diseases and improving quality of life for others around the world.

Outside of the office, Steve is a sports fan, and enjoys boating and fishing. He is also a supporter of the South Boston Neighborhood House, more commonly known as "The Ollie," an organization that aims to support South Bostonian families who are experiencing social and economic stress.

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