Senior Manager Corporate Regulatory Affairs

vor 15 Stunden

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 and internal and external development groups as required and requested by the customer and assure that the corporate RAC standard is applied.
  • Guiding operators through the issuance, submission, and maintenance of all regulatory documents (DMF’s, CMC documentations for INDs, IMPDs, NDAs, MAAs, etc.).
  • Providing hands-on support in the implementation and application of the corporate standard at the respective sites.
  • Coordinating the regulatory activities of all CARBOGEN AMCIS RAC groups during the CMC process development for corporate projects and consulting the CARBOGEN AMCIS and customer project teams in regulatory questions and as requested and agreed with the customer.
  • Chair the corporate RAC organization as part of the Corporate Quality Organization.
  • Taking over process ownership of the RAC chapter in the Corporate Management Handbook, define and maintain a harmonized RAC standard.
  • Maintaining 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
  • Familiar 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.
  • At least 5 years experience in leadership or consultancy.
  • Good intercultural skills.
  • Good to excellent communication style.
  • Good English language skills, orally and in writing.
  • Flexible working ‘attitude’ (ready to work overtime).
  • Team oriented leadership skills with strong decision-making capabilities.
  • Service mentality.

Your benefits:

  • 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 Director

    Vor 4 Tagen

    Bubendorf, Basel-Land, Schweiz CARBOGEN AMCIS Vollzeit

    As a key member of the CARBOGEN AMCIS team, you will play a vital role in ensuring the compliance and regulatory readiness of our products. We are seeking an experienced Senior Manager Corporate Regulatory Affairs to join our organization.

  • Regulatory Affairs Manager

    vor 1 Monat

    Bubendorf, Basel-Land, Schweiz CARBOGEN AMCIS Vollzeit

    Job SummaryWe 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...

  • Senior Regulatory Affairs Manager

    vor 1 Tag

    Bubendorf, Basel-Land, Schweiz CARBOGEN AMCIS Vollzeit

    Job Description:**Role Overview**We are seeking an experienced Senior Regulatory Affairs Manager to join our team at CARBOGEN AMCIS.This is a challenging opportunity for a highly skilled professional to lead our regulatory affairs function and drive the success of our organization in terms of compliance, quality, and customer satisfaction.Key...

  • Regulatory Affairs Manager

    vor 1 Woche

    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 Woche

    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 with customers...

  • Senior Manager Corporate Regulatory Affairs

    vor 1 Woche

    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...

  • Regulatory Affairs Director

    Vor 7 Tagen

    Bubendorf, Basel-Land, Schweiz CARBOGEN AMCIS Vollzeit

    Overview:CARBOGEN AMCIS is a dynamic company that offers a high-quality work environment and opportunities for professional growth.Salary: €120,000 per yearJob Description:Main Responsibilities:Develop and implement regulatory strategies for new development projects with customers and internal teams.Evaluate and maintain compliance with regulatory...

  • 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...

  • (Sr.) Manager Corporate Quality

    vor 5 Monaten

    Bubendorf, Schweiz CARBOGEN AMCIS Vollzeit

    **Department**:Quality & ESH - **Hours**:Full-time - **Location**:Bubendorf, Switzerland- **Your responsibilities**: - Act as a Business Process Owner for the QA -Release Process in SAP and the associated incident Management Process in Bizzmine (Deviation Management, Change Control, Complaint Management). - Advice and support for projects with Corporate...

  • Analytical Project Manager Qc

    vor 6 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 for CMC Development and Quality Assurance

    vor 1 Tag

    Bubendorf, Basel-Land, Schweiz Bachem AG Vollzeit

    Peptide Analysis and Regulatory Compliance ExpertWe are seeking a highly experienced Analytical Project Manager to join our dynamic team at Bachem AG. In this role, you will be responsible for leading interdisciplinary projects in peptide analysis, ensuring compliance with regulatory requirements.Your Key Responsibilities: Manage analytical activities,...

  • Analytical Project Manager Qc

    vor 2 Wochen

    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 1 Woche

    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 2 Wochen

    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 2 Wochen

    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 2 Wochen

    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 2 Wochen

    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...