Director, Regulatory Affairs - FDA Regulated Products job in Dallas, USA

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

First Name*

Last Name*

Email*

Phone Number*

Country*

Are you an employer or a jobseeker?*

Message

Job type: Permanent

Discipline: Senior/Director & VP, Consultant / Specialist, Officer /Associate

Location: United States

This vacancy has now expired. Please see similar roles below...

Proclinical is urgently recruiting for a remote Director of Regulatory Affairs of FDA Regulated Products for a CRO. As the RA Director, you will be responsible for interaction with team across a number of development programs.

Job Responsibilities:

Develop regulatory strategy for projects including creative solutions to complex problems
Knowledge of current regulations, laws and guidance both US and ex-US
Ability to take a leadership position on project teams
Independent planning, coordination and preparation of document packages for regulatory submissions, such as Pre-IND meeting requests and packages, INDs, CTDs, EOP2, and/or position papers.
Independently initiate, follow-up, negotiate, and resolve issues regarding current and future submissions, up to and including travel to, and direct discussions with the appropriate regulatory agency.

Skills and Requirements:

A minimum of a BS in Chemistry or Life Sciences
A minimum of 6-8 years pharmaceutical and/or medical device industry experience
A minimum of 4 years of regulatory affairs in FDA regulated products
RAPS certification preferred

If you are having difficulty in applying or if you have any questions, please contact Emma Vagedes-Plavcan at (+1) 347-694-4446 or e.vagedes@proclinical.com.

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.

#LI-EV1