Regulatory Affairs Manager

vor 1 Monat

Bubendorf, Basel-Land, Schweiz CARBOGEN AMCIS Vollzeit
Job Summary

We are seeking a highly skilled and experienced Regulatory Affairs Manager to join our team at CARBOGEN AMCIS. As a key member of our Corporate Quality Organization, you will be responsible for ensuring the internal standard in the regulatory compliance maintenance of regulated products under consideration of customer requirements.

Responsibilities
  • Develop and implement the RA standard at all sites, ensuring compliance with regulatory requirements.
  • Collaborate with local RAC teams to develop the CMC and regulatory strategy for new development projects.
  • Provide hands-on support in the implementation and application of the corporate standard at respective sites.
  • Coordinate the regulatory activities of all CARBOGEN AMCIS RAC groups during the CMC process development for corporate projects.
  • Chair the corporate RAC organization and maintain the e-CTD submission software.
Requirements
  • Ph.D. Chemist or Pharmacist or equivalent scientist.
  • Very good knowledge in RAC (drug substances and / or drug product) and CMC development.
  • Good GMP knowledge and familiarity with e-CTD systems.
  • At least 5 years experience in an RA department (Drug Substances or Drug Products).
  • At least 5 years work or management experience in an RA / GMP environment.
  • At least 5 years experience in dealing with authorities and customers.
  • Good intercultural skills, good to excellent communication style, and good English language skills.
What We Offer
  • A dynamic work environment with high-quality infrastructure.
  • Interesting possibilities to develop your professional skills.
  • Flexible working hours for a 40-hour week.
  • At least 5 weeks of vacation.
  • Participation in childcare costs.
  • Travel insurance for private travels.
  • Private insurance in the event of an accident.
  • 13th monthly salary is paid out without any social benefits deductions, in addition there is a profit sharing in a successful business year.

For further information, please contact the Human Resources department.

  • Regulatory Affairs Manager

    vor 24 Stunden

    Bubendorf, Basel-Land, Schweiz CARBOGEN AMCIS Vollzeit

    We are seeking a highly experienced Regulatory Affairs Manager to join our team at CARBOGEN AMCIS. In this role, you will be responsible for developing and implementing the company's regulatory affairs strategy, ensuring compliance with all relevant regulations and guidelines.About the RoleThis is a dynamic opportunity for an experienced RA professional who...

  • Senior Manager Corporate Regulatory Affairs

    vor 1 Tag

    Bubendorf, Schweiz CARBOGEN AMCIS Vollzeit

    Responsibilities:Supporting to elaborate, establish and apply the RA standard at all sites.Helping to ensure the internal standard in the regulatory compliance maintenance of the regulated products under consideration of customer requirements.Consult the local RAC teams in developing the CMC and regulatory strategy for new development projects with customers...

  • Senior Manager Corporate Regulatory Affairs

    vor 4 Monaten

    Bubendorf, Schweiz CARBOGEN AMCIS Vollzeit

    Responsibilities: Supporting to elaborate, establish and apply the RA standard at all sites. Helping to ensure the internal standard in the regulatory compliance maintenance of the regulated products under consideration of customer requirements.  Consult the local RAC teams in developing the CMC and regulatory strategy for new development projects...

  • Senior Manager Corporate Regulatory Affairs

    vor 4 Monaten

    Bubendorf, Schweiz CARBOGEN AMCIS Vollzeit

    Responsibilities:Supporting to elaborate, establish and apply the RA standard at all sites.Helping to ensure the internal standard in the regulatory compliance maintenance of the regulated products under consideration of customer requirements.Consult the local RAC teams in developing the CMC and regulatory strategy for new development projects with customers...

  • Analytical Project Manager Qc

    vor 5 Monaten

    Bubendorf, Schweiz Bachem Vollzeit

    To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our team in the QC, we are looking for a dedicated Analytical Project Manager QC (f/m/d), 100% **Your tasks**: - Working in interdisciplinary teams as responsible Analytical Project Manager for peptide and oligonucleotide NCE projects...

  • Analytical Project Manager Qc

    Vor 7 Tagen

    Bubendorf, Schweiz Bachem Holding AG Vollzeit

    **Your tasks**: - Working in interdisciplinary teams as responsible Analytical Project Manager for peptide and oligonucleotide NCE projects representing Analytical Operations in CMC sub-teams for assigned projects - Lead and manage all analytical activities including but not limited to release, stability testing, characterization of the API, method...

  • Analytical Project Manager QC

    Vor 4 Tagen

    Bubendorf, Schweiz Bachem Holding AG Vollzeit

    To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our PM team, we are looking for an experienced Analytical Project Manager QC (f/m/d) who, by knowledge and character, suits our highly motivated and dynamic team. We are seeking someone who not only complements our team capabilities but also...

  • Analytical Project Manager QC

    Vor 4 Tagen

    Bubendorf, Schweiz Bachem Vollzeit

    To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our PM team we are looking for an experienced Analytical Project Manager QC (f/m/d) who, by knowledge and character, suits our highly motivated and dynamic team. We are seeking someone who not only complements our team capabilities but also...

  • Analytical Project Manager QC

    vor 5 Stunden

    Bubendorf, Schweiz Bachem Holding AG Vollzeit

    To drive our continuous organic growth, we are constantly looking for highly qualified professionals. To strengthen our PM team, we are looking for an experienced Analytical Project Manager QC (f/m/d) who, by knowledge and character, suits our highly motivated and dynamic team. We are seeking someone who not only complements our team capabilities but also...

  • Sales Manager Generics

    vor 5 Monaten

    Bubendorf, Schweiz Bachem Vollzeit

    We are constantly looking for highly qualified professionals to drive our continuous organic growth. We are looking for a Sales Manager Generics - Business Development (f/m/d) 100% for our Generics API portfolio who will be responsible for the ongoing support of existing and new international customers in their endeavor to develop accessible medicine. This...

  • Analytical Project Manager QC

    Vor 4 Tagen

    Bubendorf, Schweiz Bachem AG Vollzeit

    Bachem ist ein börsenkotiertes, auf die Peptid-Chemie fokussiertes Technologie-Unternehmen mit einem umfassenden Leistungsangebot für die Pharma- und Biotechnologie-Industrie. Bachem ist spezialisiert auf die Entwicklung innovativer, effizienter Herstellungsverfahren und die zuverlässige Produktion Peptid-basierter pharmazeutischer Wirkstoffe. Ein...

  • Analytical Project Manager QC

    vor 1 Woche

    Bubendorf, Schweiz Bachem AG Vollzeit

    Bachem ist ein börsenkotiertes, auf die Peptid-Chemie fokussiertes Technologie-Unternehmen mit einem umfassenden Leistungsangebot für die Pharma- und Biotechnologie-Industrie. Bachem ist spezialisiert auf die Entwicklung innovativer, effizienter Herstellungsverfahren und die zuverlässige Produktion Peptid-basierter pharmazeutischer Wirkstoffe. Ein...

  • Promov. (Bio-)chemiker Als Technischer

    vor 5 Monaten

    Bubendorf, Schweiz Bachem Vollzeit

    Um unser kontinuierliches organisches Wachstum voranzutreiben, suchen wir ständig nach hochqualifizierten Fachkräften. Zur Verstärkung unseres stetig wachsenden Oligo-Teams suchen wir zum nächstmöglichen Zeitpunkt einen Technischen Autor (w/m/d) (80-100%) für das Schreiben produktionsrelevanter GMP-Dokumente. **Ihre Aufgaben**: - Sie erstellen,...

  • Director, Global Head of Exclusive Apis

    vor 5 Monaten

    Bubendorf, Schweiz Bachem Vollzeit

    The Head of Global Exclusive APIs (GEA) is a position of great strategic importance for an experienced, hands-on, execution-oriented leader, reporting to the VP, Global Sales. With a small team of currently three direct reports the Head of GEA manages Bachem’s growth driving assets and has sales responsibility for Bachem’s existing portfolio of...