Loading

20 ähnliche Stelle(n) gefunden

Loading

Regulatory Affairs Manager (f/m/d) 100% [ID: 33793]

bewerten
Bewertung abgegeben
Nemensis AG
Regulatory Affairs Manager (f/m/d) 100% [ID: 33793]

At nemensis ag, we connected thousands of applicants with their dream jobs and gave them the opportunity to develop or re-enter the job market. For our client, an international pharmaceutical company in Basel, we are in search for a Senior Regulatory CMC Manager (f/m/d).

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

Responsibilities:

  • Author 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
  • 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 with regard to 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 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)

Qualifications:

  • Degree in Science (e.g. Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent
  • Fluent English skills (oral and written), good German skills (oral)
  • Regulatory experience, 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
  • Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload

At nemensis ag you are always welcome with your personality, your ambitions and your professional experience. Share your expertise with us and apply now.

Adresse

Nemensis AG

Stellen dieser Firma abonnieren Stellen dieser Firma abonnieren
Loading

Bewertung hinzufügen

Geben Sie hier Ihre Bewertung für die Firma Nemensis AG ab!

Bewertung abgegeben