Junior GPRM/RegCMC Manager
ProClinical is advertising a vacancy for a Regulatory Affairs CMC Associate Manager position with a top 10 global pharmaceutical company in their Regulatory team. This leading Swiss pharmaceutical company are currently looking to hire the Regulatory Affairs CMC Associate Manager to be based at their site in Basel. The company employ over 100,000 professionals and have operations in more than 140 countries worldwide.
The Regulatory Affairs CMC Associate Manager will provide timely preparation of high-quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.
- Authoring high-quality CMC documentation for HA submission, with support and guidance, applying agreed CMC global regulatory strategies, assuring technical congruency and regulatory compliance, meeting agreed upon timelines, and e-publishing requirements throughout project lifecycle.
- Preparing CMC responses to health authority questions during development, registration, and product lifecycle.
- Identifying the required documentation for global submissions and negotiating the delivery of approved technical source documents in accordance with project timelines.
- Identifying content, quality and/or timeliness issues with source documents, or any other potential authoring issues that may impact submission quality or timelines, as early as possible.
- Keeping knowledge up to date regarding regulatory guidelines and requirements in all global regions, as well as for new technical trends.
- Actively participating as a member of the global team by contributing to the regulatory strategy, identifying the critical issues, and lessons learned.
- Establishing and maintaining sound working relationships with partners and customers.
- Assuming activities in support of the general department such as DRAGON support, annual and product renewal writing, coordination/collection/storage of source documentation needed for direct submission to HAs, other database entry activities (specialized department functions).
Skills and Requirements:
- Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent. An Advanced Degree is highly desirable.
- Regulatory experience preferred, and/or experience in drug/biopharmaceuticals
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
- Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
- An ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
- Demonstrable multitasking, project management, and execution skills.
- Good interpersonal skills, including communication, presentation, persuasion, and influence.
- Good organisational skills, including efficiency, punctuality, and collaboration in a team environment.
- Proficiency with computer skills, such as MS Office.
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 contact Andrea Rotmistrovsky at +44 203 854 0675 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.
£0.00 - £55000.00 per annum
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