Technical Drug Regulatory Affairs Manager (CMC Biologics)

Job description

  Job facts

Pharma Technical Regulatory (PTR) acts as the center of excellence for all technical regulatory activities for global development and marketed product. The Technical Drug Regulatory Affair Manager in the Biotech Development Group sets and maintains the technical regulatory standards for the Chemistry Manufacturing and Control (CMC) submissions. You will be responsible for developing and executing regulatory strategies for products under development.

Key responsibilities:

·  Represent the technical regulatory function on cross-functional teams and lead the interactions with global regulatory agencies
·  Provide strategic leadership and regulatory guidance to the teams/functions on technical regulatory issues
·  Successfully negotiate technical regulatory plans with affiliates and Health Authorities
·  Manage the generation of high quality global regulatory submissions for clinical trials and marketing authorization applications in collaboration with the other disciplines
·  Stay abreast of changing regulatory requirements. Analyze regulations, rules, or guidance documents and communicate potential impact to internal stakeholders.

·  Who we are

Basel is the headquarters of the Roche Group and one of its most important centres of pharmaceutical research. Over 8,500 people from approximately 90 countries work in Basel, which is one of Roche`s largest sites. Read more .
Roche is an equal opportunity employer.

Desired profile

Who you are

You're someone who wants to influence your own development. You're looking for a company where you have the opportunity to pursue your interests across functions and geographies. Where a job title is not considered the final definition of who you are, but the starting point.

Apart from your proven Regulatory CMC experience with regards to preparation of regulatory applications and submissions, planning of regulatory strategies, assessing regulatory compliance and supporting quality systems, we strongly prefer any candidate presenting Biotechnology as well as Drug- and Device combination Product experience.

Further to these, we are looking for someone with the following skills:

·  University degree (Master or PhD) in a scientific discipline – biotechnology knowledge would be an asset
·  Minimum 3 years of industry experience in regulatory, pharmaceutical development, manufacturing, or quality related field in the biopharmaceutical industry
·  Excellent communication, collaboration, and interpersonal skills.
·  Effective problem solving and strong organizational skills, including ability to prioritize tasks

Please note that some travel may be required.

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