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
Didn't find what you're looking for? Search again!
Loading more jobs...