Ra Assoc. Director/ Director - CMC- Regulatory Affairs -Biologics
PA
Type:
Full-Time
Category:
Regulatory Affairs
Job ID:
800
Opportunity Description:
Conduct CMC related business for aquisition of approvals by understanding product creation Systems objectives based on corporate policy and management strategy.
Responsibilities include (but are not limited to);
Establishing strategy and planning for CMC on submission of marketing approvals (BLA, NDA) Acquire CMC related information globally for market application and development Planning CMC development strategy CMC regulatory action in the development project team Preparation of INN, USAN application dossier Preparation of briefing package (CMC) Preparation of application document Conducting CMC change control on established (marketed) products Communicating with health authorities for post market changes
Bachelors degree required (advanced degreee preferred) BLA experience preferred Extensive knowledge and understanding of pharmaceutical development activity, CMC regulations and requirements Ability to effectively aquire quality related information and transfer that information to the team members
Addition
Full-time
If you are interested in the company name and exact location
for this opportunity, please enter your email address below.
Get In Touch With Us
Client Testimonials
"My confidential career search was handled with respect and they listened to what I wanted. I moved from New Jersey to Colorado with help from InVision Inc."
"I have never seen this quality of talent assembled for a Regulatory Vice President opening. Regulatory staffing is very unique. InVision produced great results in a short amount of time."
"I called InVision on a Tuesday morning with a very unique regulatory opening and they presented (4) qualified candidates in 3 days... We hired the second person they submitted. Results! Thank You"
"The staff at InVision prepared me for a great interview and guided me along the interview process step by step. Unique niche recruiters have come and gone InVision has been around for years and having RA/QA knowledge really helps."
"Your friend Paula should contact the world's greatest RA and QA recruiting company, InVision I can serve as a reference if needed."
"I sent InVision my regulatory resume looking to relocate to California and they presented (2) director level openings right away and they followed up with me. Feedback from my resume really helped."
