Regulatory Affairs Manager - Cary, United States - Compass Consulting

Compass Consulting Cary, United States

2 weeks ago

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.?

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