The Wellington Group has been engaged to find an experienced CMC Manager to be part of the Regulatory Affairs group for a growing and profitable biologics, pharmaceutical and animal health company. Put your RA expertise to work today in a great new job!

The CMC Manager will support the Director in the management of CMC-related submissions to FDA and other regulatory authorities worldwide. The CMC Manager will assist in the development and execution of CMC regulatory strategies and regulatory submissions (IND, BLA, etc.) for company products. They will manage CMC post approval changes for US and International marketed products.

Responsibilities include:

• Prepare CMC regulatory documents based on technical information from R&D/Operations/Quality for submission to FDA, USDA, and (where applicable) international regulatory authorities
• Prepare CMC submissions for IND, BLA and post approval CMC supplements, and supports their approval by regulatory authorities
• Participate in meetings on CMC regulatory issues at the request of the Director of Regulatory Compliance
• Track, maintain and coordinate multiple CMC project timelines and coordinate on-going activities across multiple functions
• Maintains awareness of and expertise in cGMPs and CMC related regulations and guidelines
• Manage Change Control process

Company is motivated to hire ASAP!

The qualified candidate will have:

•  Bachelor’s degree in a scientific discipline or equivalent
• Minimum of 3-5 years experience in pharmaceutical industry. Minimum 3 years experience in CMC and qualifying quality assurance role is required
• Knowledge of cGMP/FDA regulations
• Knowledge of US and/or international CMC regulatory requirements
• Experience with biologics is desirable
• Strong teamwork, interpersonal skills and communication skills are essential
• Proficient in MS Office applications

Industry: Biologics, Veterinarian Medicine, Biotechnology, Pharmaceuticals, USDA, CMC Submissions
Job Code: BHJOB3594_271
Recruiter: Heather

Permanent position with an employee centered company offering great benefits, salary, bonus and relocation assistance.

Don’t wait, apply with The Wellington Group today!
(all information will be held in the strictest of confidence)

The Wellington Group ( http://www.twgrecruiters.com ) 910-338-2795