Associate Director / Director, Regulatory Affairs 1245069

Company: Stratacuity: Proven Scientific Placement
Location: Cambridge
Posted on: June 24, 2022

Job Description:

Job Scope & Purpose:Our client, made up of leading experts in cardiovascular medicine, is advancing an exciting pipeline of precision genetic medicines. They are looking for an experienced Regulatory Affairs professional to join their growing team. The position reports to the VP, Regulatory Affairs and will be responsible for planning, developing, and implementing regulatory strategy, submissions, and compliance activities for programs in early development and beyond to support regulatory approvals.Primary Job Responsibilities:

• Plan, design, and implement clinical, nonclinical, and CMC regulatory strategy including the preparation and submission of regulatory applications.
• Manage the development of high-quality regulatory documents, including direct authoring and/or reviewing of documents such as IND/IMPD/CTA submissions, meeting requests and briefing documents, and responses to regulatory requests for information while adhering to timelines, company standards, and industry best practices.
• Act as regulatory contact with regulatory authorities, including participating in meetings with regulatory authorities and managing meeting requests and responses to requests for information from authorities.
• Represent regulatory affairs on cross-functional project teams and provide guidance to and oversight of internal and external resources to ensure the company remains in compliance with applicable and phase-appropriate regulatory standards, guidelines, and best practices.
• Contribute to the development of risk assessment pertaining to the quality, safety, and efficacy aspects of programs and applications.Primary Job Requirements:
  • Advanced degree (MS, PharmD, Ph.D., MD) in scientific discipline preferred
  • 8+ years' experience in pharmaceutical/biotechnology environment
  • 5+ years in Regulatory Affairs
  • Experience with complex biologics preferred
  • Working knowledge of domestic and international regulations and guidelines regarding phase-appropriate drug development, along with the application of principles, theories, and practices
  • Direct experience interacting with regulatory authoritiesAbout Stratacuity:Whether you are seeking a career change or simply interested in becoming part of our network, you will appreciate the ethics guiding each Stratacuity team member. We build lasting relationships with exceptional biopharmaceutical talent and take great care to protect your personal information. Upon receiving your inquiry, you may be directly contacted by a Stratacuity team member to discuss your career goals. We will not share your information with anyone without your direct prior consent.PROVEN SCIENTIFIC PLACEMENT---Stratacuity is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Stratacuity will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact us.

Keywords: Stratacuity: Proven Scientific Placement, Cambridge , Associate Director / Director, Regulatory Affairs 1245069, Executive , Cambridge, Massachusetts