Reference Number: JO-2010-456024
Regulatory Senior Associate, CMC
Job Type: Permanent
Role: Regulatory Senior Associate, CMC
Salary: Highly competitive + benefits
employment: full time, permanent
Regulatory Professionals are collaborating with a biopharmaceutical company that researches, develops, and commercializes drugs. The company focuses primarily on antiviral drugs used in the treatment of HIV, hepatitis B, hepatitis C, and influenza, including Harvoni and Sovaldi. This role will provide CMC regulatory support for our clients investigational and commercial products across Europe, with a focus on supporting products in Inflammatory Diseases and Emerging Viral Diseases.
This opportunity will offer you the chance to grow your Regulatory Affairs CMC expertise across a range of territories with diverse regulatory requirements and processes and an evolving regulatory landscape
Other duties will include:
Under general direction from a RA CMC Manager, the Senior Associate RA CMC will be responsible for.
Preparation and/or coordination of regulatory submissions for our clients investigational and commercial products in the EU and International markets, primarily supporting the Inflammatory Diseases and Emerging Viral Diseases programs. This could include the support of major MAA submission filings in the EU, Switzerland, and Israel.
Preparation of high-quality chemistry, manufacturing, and controls (CMC) documentation to support original MAAs, variations, and renewals.
Preparation of Quality components for investigational medicinal products to support clinical trial applications and amendments in the EU and International markets.
Co-ordination of responses to CMC questions from regulatory authorities.
Providing input on CMC regulatory requirements to manufacturing and pharmaceutical development groups for clinical trials, new product registrations, and post-approval changes.
Providing regulatory assessments for proposed changes to investigational and commercial products.
Sustaining an up-to-date awareness of CMC regulatory requirements for applicable territories and communicating key intelligence to the organization in a timely manner.
Introducing or contributing to local process improvements that have an impact on the working of the Regulatory Affairs function or other departments.
The Senior Associate RA CMC will work closely with international colleagues to ensure consistency with responses to questions
Knowledge, Experience & Skills
Right to work in the UK
Typically requires a BA or BS degree in a relevant discipline and relevant experience in CMC Regulatory Affairs.
Experience in the preparation and maintenance of CMC components for regulatory submissions.
General understanding of CMC regulatory requirements and quality guidelines, including ICH and regional requirements.
Excellent organization skills and ability to work on several simultaneous projects with tight timelines.
Excellent verbal and written communication skills and interpersonal skills.
Regulatory Affairs CMC experience of investigational and commercial products.
Relevant industry experience is advantageous.
If you would like to apply for this position, please contact Amani via firstname.lastname@example.org. If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*