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Regulatory Affairs CMC Senior Manager (m/f)

Aequor Consulting GmbH
Basel

5T

Aequor Consulting GmbH - that's us! A young, dynamic and motivated team that aims to bring companies and talents together. We do this both in personnel placement and in personnel staffing. Even with large, complex and international projects, we can rely on the support of over 4,000 colleagues from the headquarters of Aequor Technologies Ltd. We are pleased to support you according to our slogan - “We listen. We deliver."

Regulatory Affairs CMC Senior Manager (m/f)

For one of our international well-known Swiss pharmaceutical clients we are looking for a highly motivated Regulatory Affairs CMC Senior Manager (m/f) in Basel.
Your Responsibilities
  • Responsible for high-quality CMC documentation using agreed CMC global regulatory strategies and regulatory compliance and e-publishing requirements throughout project lifecycle
  • Prepare CMC responses to health authority questions during development, registration and product lifecycle phases
  • Quick identification of content, quality and/or timeliness issues with source documents along with authorization issues
  • 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 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)
Your Profile
  • Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent. Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent would be an added advantage
  • 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 time pressure and workload. Effective risk assessment skills
  • Fluent English language skills. Good skills in other local language would be preferred
  • Excellent written/spoken communication and negotiation skills. Computer literacy
Benefits
  • 5 weeks vacation / 40h week
  • LinkedIn Learning with over 5000 trainings
  • Assumption of certification costs
  • Reka-Card with 20% discount up to CHF 2'400
  • Possibility for home office
  • CHF 400 contribution to fitness subscription