Regulatory Affairs Manager - Compass Consulting

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.?

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.

 
Education:

• BS/BA in Chemistry, Pharmacy, or Biologic Science. Regulatory Affairs Certification preferred.

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.

 
Education:

• BS/BA in Chemistry, Pharmacy, or Biologic Science. Regulatory Affairs Certification preferred.