Manager, US Regulatory Affairs R&D - Pipeline

Purpose

Contribute to the Company’s success by providing regulatory guidance to the global R&D Core Team.

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 subteams 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 interpret 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

Technical Skills