Expiry Date: 08-02-2020
Category Regulatory Affairs
Job Type: Full Time
RA CMC Experts / Specialists - Grade Sr Manager / Associate Director
Are you an experienced Technical Regulatory Affairs professional who is looking to conquer new horizons with an innovative biotech and one of the biotech's best success stories? Then you will certainly find the below lines interesting to read!
A well-renowned biotech with a very advanced pipeline is seeking talented RA CMC professionals to step in the role of a RA CMC RL in one of their sites based in Raleigh, Durham, USA.
This is a strategic position related to the development and implementation of RA CMC strategy for biologics on regional and international level.
As a Regulatory CMC RL your key responsibilities will be:
* Preparation, review and approval of regional Regulatory CMC submissions
* Leading on communication with Health Authorities
* Providing technical and thought leadership to cross-functional teams in matrix structure
* Coaching and raising awareness on latest changes and trends in the industry across the business
* Acting as the Regional RA CMC Leader for the region where you are located for either major marketed products or for a NCE or NBE in development.
With the above in mind, you will be provided with a fantastic opportunity to take ownership over a dedicated project and lead highly professional teams in matrixed environment all the way to international success.
If you are still wondering if this is a good fit for you, certainly the below key qualifications for the role will help you:
* Broad experience in communicating with Health Authorities in more than 1 region and minimum of 5 years' experience in Regulatory CMC
* Successful track record of delivering or assisting a more experienced CMC Lead (dependent on grade) for M3 builds, CBE30s / PAS, complex variations or full NDAs, BLAs or CTA/IND/ IMPDs
* Proven ability to plan and work with remote teams based across the globe
* Energetic and communicative personality, ready to mentor and help others raise their experience and capability.
The company offer a great package including basic, bonus, and stock plan (high performing), and will help you develop up based on merit. The line managers have very good track records, and are known for developing their people. We have worked with this global head for around 8 years and know they will help you to the next level.
If all the above has grabbed your interest and you are curious to learn more about this great opportunity, please send a recent version of your resume and your contact information and I will gladly discuss the details with you.
To apply for this role, please press the red “Apply for position”, or contact me, David, on 855.505.1382 to find out more about this role and other positions we have for other companies in the RTP area.
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