Regulatory Consultant CMC
I have a unique opportunity for a Regulatory Consultant CMC to work with an established Pharma, via a global consultancy division.
This role will work in a global team on the development and definition of the CMC content requirements for strategies for timely approval of regulatory filings throughout the product life cycle (IND, IMPD, NDA, BLA, MAA) and, provide regulatory support on assigned global projects.
This is a homebased role which offers an attractive package and a number of interesting career development opportunities.
BA/BS in scientific or technical discipline or advanced degree
3-5 years of biopharmaceutical regulatory experience
Thorough understanding of the drug development process for all phases of pharmaceutical development and applied comprehensive understanding of regulations and guidelines to enhance probability of regulatory success and regulatory compliance
Experience preparing CMC sections of INDs, NDAs, and supportive amendments and supplements (ICH Modules 2 and/or 3)
Some Job Responsibilities include:
Develop submission plans and contribute to the execution of timely and innovative regulatory strategies in support of global development and life cycle management of assigned projects
Collaborate with Global RA CMC lead and/or Regional RA CMC lead to provide regulatory support for assigned projects
Communicate with Regulatory Operations on the planning of global Clinical Trial Applications, marketing applications and post-approval supplements and variations
Contribute to the development of and to the definition of the CMC content requirements for strategies for timely approval of regulatory filings throughout the product life cycle (IND, IMPD, NDA, BLA, MAA)
Prepare and coordinate the review and approval of submission-ready documents
If interested, please apply or email directly at firstname.lastname@example.org
- Agency: Cpl Life Sciences
- Contact: Ed Taylor
- Reference: JO-2111-480927
Website: Cpl Life Sciences
- Posted: 25th November 2021
- Expires: 23rd December 2021