13 days ago
Hamlyn Williams has partnered with an exciting Pharmaceutical company, based in New Jersey, in their search for a Director of Regulatory Affairs. Our client seeks a candidate who will support a variety of regulatory projects, including developing and implementing global regulatory strategy and life cycle management of said projects.
This is an opportunity to be part of a very passionate team and to be a critical member on many projects.
- Developing global product regulatory strategy to efficiently obtain approval by regulatory agencies for a variety of projects simultaneously
- Communication with the health authorities, including: calls and email, chair meetings, prepare the internal team for meetings with FDA at any phase of drug development
- Leadership in preparation of regulatory filings for submissions including: IND applications, meeting requests, post-marketing commitments and annual reports
- Reviewing global marketing applications, clinical study reports, investigator brochures before release
- Conducting initial IND and Clinical Trial Applications (CTA) content review and approval
- Manageing regulatory project aspects including strategy, resources, costs, time and vendors
- 5+ years of experience in pharmaceutical regulatory affairs experience
- Demonstrated experience with IND, NDA, GCP, ICH and other regulatory guidance requirements
- Ability to manage multiple responsibilities with a high degree independence
- Strong written communication skills
- MS or Doctoral degree in an applicable field of study
Apply here or email firstname.lastname@example.org if you are interested in working with a leading organization in the industry.