Director of Regulatory Affairs
Proclinical is seeking a Director of Regulatory Affairs for an innovative pharmaceutical company located in Monmouth Junction, NJ.
The Director, Regulatory Affairs is responsible for providing regulatory leadership for products in development through New Drug Application (NDA) approval as well as life cycle management of the same. This individual will serve as a key partner with Clinical Development and Research and Development (R&D) in supporting clinical programs for products in both early and late-stage development.
Must be eligible to work in the US.
- Develops and implements submission strategies for IND and NDA applications
- Leads the planning, writing and review of all regulatory submissions to support pre-IND, original IND, 505(b)1&2 NDAs including FDA meeting requests and packages
- Leads and actively participates in meetings with the FDA and other Health Authorities, as required
- Critically reviews and approves reports and protocols from Clinical Development and documentation from Research and Development (R&D), Quality, Technical Operations, Labeling and other appropriate departments and internal stakeholders
- Represents Regulatory Affairs on project teams and provides regulatory advice (non-CMC) to internal and external customers
- Keeps up to date on FDA and International Council on Harmonisation (ICH) guidances and interprets/informs project teams of implications to drug development
- Creates and manages project timelines; evaluates changes to maintain submission goals and timelines; Establishes good working relationships and manage relationships with internal and external partners
- Provides feedback and coaching to others in the Regulatory Affairs Department
- Manages, coaches and mentors direct reports
Skills and Requirements:
- Masters degree in a science field and minimum 8 years Regulatory Affairs experience in the pharmaceutical industry in positions of increasing strategic and leadership responsibility OR Bachelors degree in a science field and minimum 9 years Regulatory Affairs experience in the pharmaceutical industry in positions of increasing strategic and leadership responsibility supporting small molecule drug development.
- Hands-on experience or support in multiple strategic and operational facets of pharmaceutical development. These areas may include, but not limited to target product profile development, clinical, pharmacokinetics, preclinical, statistics, safety reporting, labeling, submissions, publishing, etc.
- Thorough, working knowledge and understanding of small molecule development process
- Proven track record of successful product filings in the pharmaceutical industry
- Recent experience drafting documentation for regulatory applications
- Proven record of developing and maintaining successful working relationships with the FDA
- Demonstrated understanding of the regulatory process and technical competence in core areas of drug development
- Ability to analyze and interpret scientific data and regulatory guidelines
- People management experience
- Ability to influence without direct authority
- Proficiency with Microsoft Office
- Excellent verbal and written communication and skills
- Ability to work independently and collaboratively, as required, in a fast paced, matrixed, team environment consisting of internal and external team members
- Analytical thinking with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines
- Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects
- Fluent in English (verbal and written)
If you are having difficulty in applying or if you have any questions, please contact Julia Ahadi at +(1) 512-643-4324 or firstname.lastname@example.org.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.