Jobvertise
Director/Associate Director Regulatory Affairs CMC - (US-PA-Malvern)
Compensation: $130K - $165K / Year
Minimum Education: Bachelors
Job Type: Full Time
Jobcode: JV 092309
Email this job to yourself or to a friend | Job Match Test | Resume Guide
Click Here to Apply OnlinePeople enter the pharmaceutical/ biopharmaceutical industry for all sorts of reasons; some have a passion for science, others care deeply about preventing disease and helping to improve the quality of people’s lives, still others want to work in a “stable” profession and/or to earn a better than average salary.
The BrilliantLeap division of Selective Search Inc. understands what drives Pharmaceutical Industry professionals and we partner with Life Science employers whose philosophies mirror our own. We also actively seek to work with both employers and individuals whose growth is on the upswing and whose reputations and track records are “rock solid” as this pairing tends to serve both parties best.
At present we are conducting a search for an Associate Director/ Director Regulatory Affairs/CMC for a rapidly growing pharmaceutical client. The selected candidate will be responsible for:
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.
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.
The minimum requirements for the role are:
Bachelors degree required (advanced degree preferred).
Extensive knowledge and understanding of pharmaceutical development
activity, CMC regulations and requirements.
BLA experience.
Ability to effectively acquire quality related information and transfer that information to the team members.
To learn more about this opportunity, please send your resume to Virginia@BrilliantLeap.com or call her at 973-744-8164.
Virginia Backaitis
Brilliant Leap
41 Vreeland Ave
Totowa, NJ 07512
Phone: 973-744-8164
|
|
|
Powered by
Jobvertise |