Regulatory Affairs CMC Manager
Proclinical are recruiting for a Regulatory Affairs CMC Manager to join a pharmaceutical organisation. This role is on a contract basis and is located in Cambridge.
- Arrange the preparation of high-quality CMC documents to assist with regulatory proposals in global regions such as Asia, Latin America, Middle East, Eastern Europe and Africa.
- Collaborate with pharmaceutical development, manufacturing, QA and any external partners to deliver the CMC elements for marketing applications, variations and renewals.
- You will arrange the preparation of responses to CMC questions from regulatory authorities.
- Uphold updated consciousness of CMC regulatory needs for suitable territories and discuss crucial intelligence to the business in a timely manner.
- Other duties may be assigned to this role.
Key Skills and Requirements:
- Familiarity within regulatory affairs and expertise in regulatory needs, which involves IH needs and regional needs.
- Able to prepare and finalise CMC regulatory reports and handle the ongoing upkeep of current product licenses.
- A well-versed and proficient individual with knowledge in regulatory documentation and proposal management systems.
- Interpersonal and communication skills both verbally and in writing.
- An organised individual with the ability to work on various projects with tight timelines.
If you are having difficulty in applying or if you have any questions, please contact Peter Duvall on email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.