RA Manager - CMC Biologics
An exciting opportunity has arisen for a RA Manager - CMC Biologics to join a global biopharmaceutical company based in Cambridge. A very patient focused company, who scientific research has resulted in 15 marketed products that are benefitting hundreds of thousands of people, a pipeline of late-stage drug candidates and unmatched patient access programs to ensure medications are available to those who could otherwise not afford them.
Essential Duties and Job Functions
- Ensure that CMC dossiers meet ICH format and content requirements, as well as the specific local requirements of individual countries.
- Must be pro-active in staying current with registration requirements in each of the applicable regions, and must communicate this information to the corporation on a timely basis.
- Work proactively to build contacts with local Health Authorities, and to present a positive image of the company in all discussions with Health Authorities.
- Responsible for ensuring timely discussion with Health Authorities regarding responses to questions, and will work with international colleagues to ensure consistency of responses to international Health Authorities.
- Will be expected to use industry network to maintain an awareness of the "pulse" of CMC best practices, and to disseminate this information to the corporation.
- Assist in drafting background packages for meetings with Health Authorities, and may be required to develop basic strategies.
- Form ad hoc task forces to address critical CMC issues on behalf of project and department teams
Knowledge, Experience and Skills
- Must have significant experience in regulatory affair and an extensive knowledge of regulatory requirements, including ICH requirements and regional requirements for assigned territories
- Must be capable of the preparation and finalization of CMC regulatory dossiers and managing the ongoing maintenance of existing product licenses
- Well versed and competent with regulatory documentation and submission management systems
- Excellent verbal, written and interpersonal communication skills are required
- Must have excellent organizational skills and an ability to work on a number of projects with tight timelines
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Latifah Khan on 0203 8234 367 or upload your CV on our website www.proclinical.com. A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
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