|
|
|
|
 |
| CMC Manager - Job # 1923 |
|
Client Synopsis:
Full Scale Solutions is currently recruiting for the following position in based in Caldwell County, NC.
|
|
Essential Duties and Responsibilities:
Our Client is currently seeking a Manager in a CMC role in their Regulatory Affairs Department. As a CMC Manager of Regulatory Affairs, this person 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 our Client's products. They will manage CMC post approval changes for US and International marketed products.
Under the general supervision of the Director of Regulatory Compliance, CMC Manager provides CMC regulatory support for IND and new BLA submissions, and for post approval CMC changes for all marketed products.
Duties 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.
|
|
Requirements:
- 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.
|
|
 For confidential consideration please submit a resume and salary history to
claire@fullscalesolutions.com.
Full Scale Solutions is an equal opportunity employer.
|
|
|
|
|
|
