Technical Regulatory Manager - Biologics Development

Job description

·  Job facts

The Technical Regulatory Affairs Biologics department in Basel is responsible for all technical regulatory questions regarding biotechnological drugs in all stages from development to marketing of the product. We ensure that technical regulatory documents are generated in high quality and in accordance with global timelines. We set up regulatory strategies aiming for the development and production of innovative medicines that meet the highest standards for quality, safety and efficacy for our patients.

As Technical Regulatory Manager in the division Pharma Biotech Basel your duties would consist of the following areas of responsibility:

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Generate and coordinate the lifecycle of regulatory documentation regarding development, manufacturing and quality control of biotechnological medicinal products in consideration of the relevant regulatory guidelines

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Ensure the development and progress of projects in alignment with the global project team

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Establish and maintain a strong collaboration to the project team and take over accountability for the response to enquiries and deficiency reports from regulatory authorities

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Preparation and conduct of health authority meetings

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Involvement in tracking and assessment of new regulatory guidelines, and their implementation, if required

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Be the person of contact for all regulatory affairs departments at the different company sites, as well as for external partners and clients for your respective projects

You hold a university degree and ideally a PhD in a life science area like Biology, Chemistry or Pharmacy. You can rely on your excellent communication and moderation skills at all times.

For this interesting role you will bring the following background and competences:

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3-5 years of experience in the pharmaceutical industry in the areas of Regulatory Affairs, Technical Documentation or Regulatory Quality Requirements concerning Biologics

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Experience in new modality products for Cell and Gene Therapy is a strong asset

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Detailed knowledge of regulatory guidelines (FDA, EMEA, ICH, GMP, etc.) is expected

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Ability to work in a team and building trusted relationships

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Highly reliable with an accurate working style

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Interest in actively engaging in a global network. Experience in interacting with associations for development of industry positions on key regulatory topics

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Willingness and confidence in working in a changing and evolving environment and within that striving for continuous improvement

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Excellent proficiency in spoken and written English conclude your profile, German is an advantage

Roche embraces diversity and equal opportunity in a serious way. We are committed to building a team that represents a variety of backgrounds, perspectives, and skills. The more inclusive we are, the better our work will be.

If you have questions then please check our FAQs and videos on careers.roche.ch/faq.

Roche ist ein Arbeitgeber, bei dem Chancengleichheit zählt.
Regulatory Affairs, Regulatory Affairs > General Regulatory Affairs

·  Who we are

Bei Roche leisten 98,000 Menschen in 100 Ländern Pionierarbeit im Gesundheitswesen. Gemeinsam haben wir uns zu einem weltweit führenden, forschungsorientierten Healthcare-Konzern entwickelt. Unser Erfolg baut auf Innovation, Neugier und Vielfalt.

Roche ist ein Arbeitgeber, der die Chancengleichheit fördert.