Pharmiweb ChannelsAll | PharmaCo | Clinical Research | R&D/BioTech | Sales/Mktg | Healthcare | Recruitment | Pharmacy | Medical Comms

Pharmiweb.com RSS Feed Pharmiweb.com RSS Feeds

Job Details

Associate Director Regulatory Affairs-CMC

Company: EPM Scientific
Location: Boston
Reference: 196051/001
Closing Date: 16 Aug 18
Type: Permanent
Salary (£): Negotiable
Benefits:

Job Summary:

Job description An innovative biopharmaceutical company in the Greater MA area is looking to bring on an Associate Director RA-CMC in a brand new role. This company has a robust pipeline that includes products within women's healthcare, regenerative medicine, and a few others. ...

Requirements:

Job description



An innovative biopharmaceutical company in the Greater MA area is looking to bring on an Associate Director RA-CMC in a brand new role. This company has a robust pipeline that includes products within women's healthcare, regenerative medicine, and a few others. The responsibilities and qualifications of the role can be found below:

Responsibilities:

*

Lead oversight in all CMC submissions and ensure that submissions comply with applicable global regulatory requirements as well as company policies and procedures,
*

Be the interface for the FDA and International Health Authorities regarding all CMC matter
*

Prepare regulatory assessments of post-marketing manufacturing changes and in preparing the technical portion of INDs, NDAs, amendments, and supplements.
*

Contribute to the development of domestic and global regulatory strategy



Qualifications:

*

Minimum of 6-8 years of regulatory CMC experience
*

Bachelors Degree in a Life Sciences/relevant scientific discipline, advanced degree preferred
*

Ability to be hands-on and work in a fast-paced environment

Apply for this job: Associate Director Regulatory Affairs-CMC

Contact Information:

Address:  Head Office
Ground Floor 21 Lombard Street London
EC3V 9AH
England
Tel:  +44 (0)20 3758 8855
Website:  Visit Our Web Site

Advertising
Site Map | Privacy & Security | Cookies | Terms and Conditions

PharmiWeb.com is Europe's leading industry-sponsored portal for the Pharmaceutical sector, providing the latest jobs, news, features and events listings.
The information provided on PharmiWeb.com is designed to support, not replace, the relationship that exists between a patient/site visitor and his/her physician.