Junior GPRM/RegCMC Manager

This Junior GPRM/RegCMC Manager job is an exciting opportunity to join one of the top 10 global pharmaceutical companies in their Regulatory team. This leading Swiss pharmaceutical company are currently looking to hire a Junior GPRM/RegCMC 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.

Under supervision, provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.

Job Responsibilties:

• Author high-quality CMC documentation for Health Authority (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.
• Prepare CMC responses to health authority questions during development, registration and product lifecycle.
• Identify the required documentation for global submissions and negotiate the delivery of approved technical source documents in accordance with project timelines.
• Identify 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.
• Keep knowledge up to date regarding regulatory guidelines and requirements in all global regions as well as for new technical trends.
• Actively participate as a member of the global team by contributing to the regulatory strategy, identifying the critical issues and lessons learned.
• Establish and maintain sound working relationships with partners and customers.
• Assume activities in support of the general department such as DRAGON (Drug Reg Affairs Global Regulatory Compliance System) 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:

• Minimum: Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
• Desirable: Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.
• Languages: Fluent English required (oral and written). Good skills in site (local) language desired (oral)
• 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.
• Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
• Effective planning, organizational and interpersonal skills.
• Reasonable approach to risk assessment.
• Excellent written/spoken communication and negotiation skills.
• Computer literacy.
• Chemistry/Pharmacy background with a little bit of knowledge of pharma industry and/or CMC but should mainly show interest for Lean/Six Sigma approach.
• Actually there is no programs/tools on which the candidates must be experienced on, rather some programing languages (C, C++, R, VBA, Python, SQL, Arduino, data mining, statistics, data visualization...) experience and most of all a good mindset (problem solving, efficient, solution oriented, lean approach...)

To Apply:

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 Andrea Romistrovsky on +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.

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