Director of Regulatory Affairs Cmc

vor 2 Wochen


Basel, Schweiz Proclinical Vollzeit

Proclinical are recruiting a Director of Regulatory Affairs CMC - CDMO Switzerland for a pharmaceutical consultancy. This role is on a permanent basis and is located in Basel.

**Responsibilities**:

- Lead the system owners through the issuance, proposal and upkeep of all regulatory documents such as DMF's, CMC documentations for INDs, IMPDs, NDAs, MAAs, etc.
- Offer assistance in the execution and implementation of the company standard at the respective sites.
- Serve as a SME in audits and inspections and chair the company RAC organisation as part of the corporate Quality Organisation.
- Guarantee that the internal standard within the regulatory compliance upkeep of the regulated products under consideration of customer needs.
- You will uphold CGAM owned registration files and assist customers in preserving the files, which might include the post approval change management.
- Assume responsibility for process ownership of the RAC chapter within the corporate management handbook, outlining and uphold the harmonised RA standard.
- Other duties may be assigned to this role.

**Key Skills and Requirements**:

- Educated to an advanced degree level in a chemistry, pharmacy or similar discipline.
- Know-how of RAC such as drug substances and/or drug product or CMC development.
- Expertise on GMP.
- Prior involvement in e-CTD systems.
- At least 5 years of experience working within a RA division such as drug substances or drug products.
- At least 5 years of experience either working or in a management role within a RA/GMP setting.
- At least 5 years of experience handling authorities and customers as well as experience in a leadership or consultancy role.
- Intercultural skills.
- Communication skills both verbally and in writing.
- Fluency in the English language.
- A flexible working mindset.
- Leadership abilities with the capacity to make solid decisions.
- Customer focused attitude.

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

LI-LS2

Regulatory



  • Basel, Schweiz Barrington James Vollzeit

    Basel-Stadt - 30-05-2023 - JOB TYPE - Permanent - EMP TYPE - Full-Time - EXPERTISE - Regulatory Affairs - SALARY TYPE - Annually - SALARY - Negotiable Job Title: Regulatory Affairs Director Department: Regulatory Affairs Hours: Full-time Location: Basel, Switzerland **Summary**: We are seeking a highly qualified individual to join our organization as...

  • Director Regulatory Affairs 80-100%

    Gefunden in: beBee S CH - vor 4 Wochen


    CH-4051 Basel SFL Regulatory Affairs & Scientific Communication GmbH Teilzeit

    Would you like to join and contribute to a successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? SFL, a Veristat company, and its dynamic cross-functional team provide premium consulting support to companies in the healthcare and life sciences fields. Our clients...

  • Associate Director Regulatory Affairs Biosimilars

    Gefunden in: Talent CH C2 - vor 1 Woche


    Basel, Schweiz Abbott Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries. Abbott...

  • Associate Director Regulatory Affairs Biosimilars

    Gefunden in: beBee S CH - vor 3 Wochen


    Basel, Schweiz Abbott Laboratories Vollzeit

    Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 113,000 colleagues serve people in more than 160 countries.Abbott...


  • Basel, Schweiz SimplyVision GmbH Vollzeit

    For our customer located in Basel/Switzerland we are currently looking for a**: Regulatory Affairs CMC Manager **(M/F/x) **Tasks & Responsibilities / Must Haves** - Responsible for regulatory activities specifically related to chemistry, manufacturing, and control (CMC). Activities such as the preparation & publication of REG CMC documentation for...


  • Basel, Schweiz Coopers Group AG Vollzeit

    Regulatory Affairs Manager CMC For our client in Basel, we are looking for RA CMC Manager who will be responsible for global CMC submission activities for assigned projects. **Responsibilities**: - Identify the required documentation and any content, quality and/or timeliness issues for global submissions and negotiate the delivery of approved technical...

  • Director Regulatory Affairs

    Gefunden in: Talent CH C2 - vor 1 Woche


    Basel, Schweiz Veristat Vollzeit

    Description : Director Regulatory Affairs Would you like to join and contribute to a successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? SFL, a Veristat company, and its dynamic cross-functional team provide premium consulting support to companies in the...

  • Senior Manager Regulatory Affairs 80-100%

    Gefunden in: beBee S CH - vor 4 Wochen


    CH-4051 Basel SFL Regulatory Affairs & Scientific Communication GmbH Teilzeit

    Would you like to join and contribute to a successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? SFL, a Veristat company, and its dynamic cross-functional team provide premium consulting support to companies in the healthcare and life sciences fields. Our clients...


  • Basel, Schweiz CTC Resourcing Solutions Vollzeit

    **The Life Science Career Network** Our client is a leading global player in the Pharmaceutical industry with global headquarters in Basel, Switzerland. They are undergoing a transformation with respect to culture and outside perception. The organisation focusses on novel therapies in Oncology and Ophthalmology and is also currently developing a...


  • Basel, Schweiz Bayer Vollzeit

    **At Bayer we’re visionaries, driven to solve the world’s toughest challenges and striving for a world where ,Health for all, Hunger for none’ is no longer a dream, but a real possibility. We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our...

  • Ra Cmc Manager

    Vor 6 Tagen


    Basel, Schweiz Warman O'Brien Vollzeit

    A Regulatory Affairs CMC Manager is required to join a global pharmaceutical company based in Basel on an 18-month contract. **What you will be doing**: - Support all global CMC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products. - Identify the required documentation and any content, quality...


  • Basel, Schweiz Coopers Group AG Vollzeit

    **CMC Regulatory Project Coordinator** You will be repsonsible for coordinating the budget of the CMC development activities of the late stage phase within the CMC Development organization. You will collaboaret with internal and external partners to support deliverables according to project timelines and defined budget. **Responsibilities**: - Monitoring...

  • Regulatory Affairs Manager

    Gefunden in: beBee S CH - vor 4 Wochen


    Basel, Schweiz Proclinical Vollzeit

    Proclinical are recruiting for a Regulatory Affairs Manager - EMEA to join a pharmaceutical organisation. This role is on a permanent basis and is located within the EMEA with the ability to either work remotely or on a hybrid basis.Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance....

  • Regulatory Affairs Manager

    Gefunden in: beBee S CH - vor 3 Wochen


    Basel, Schweiz Proclinical Vollzeit

    Proclinical are recruiting for a Regulatory Affairs Manager - EMEA to join a pharmaceutical organisation. This role is on a permanent basis and is located within the EMEA with the ability to either work remotely or on a hybrid basis.Please ensure that you are eligible for working in the location without any sponsorship or relocation assistance....

  • Director Quality Assurance 80-100%

    Gefunden in: beBee S CH - vor 4 Wochen


    CH-4051 Basel SFL Regulatory Affairs & Scientific Communication GmbH Teilzeit

    Would you like to join and contribute to a successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? SFL, a Veristat company, and its dynamic cross-functional team provide premium consulting support to companies in the healthcare and life sciences fields. Our clients...


  • Basel, Schweiz Moderna Vollzeit

    **The Role**: Joining Moderna offers the unique opportunity to be part of a pioneering team that's revolutionizing medicine through mRNA technology with a diverse pipeline of development programs across various diseases. As an employee, you'll be part of a continually growing organization working alongside exceptional colleagues and strategic partners...

  • Senior Manager Regulatory Affairs

    Gefunden in: Talent CH C2 - vor 1 Woche


    Basel, Schweiz Veristat Vollzeit

    Description : Senior Manager Regulatory Affairs Would you like to join and contribute to a successful and growing multi-national organization in the heart of Europe and one of the world’s leading regions of the pharmaceutical industry? SFL, a Veristat company, and its dynamic cross-functional team provide premium consulting support to companies...

  • Ra Cmc Manager

    Vor 6 Tagen


    Basel, Schweiz Hobson Prior Vollzeit

    Hobson Prior are looking for a RA CMC Manager to join a brilliant pharmaceutical corporation on a contract basis located in Basel. Our client is focused on improving and prolonging the lives of many. Please note that to be considered for this role you must have the right to work in this location. **Key Responsibilities**: - For this position, you will be...


  • Basel, Schweiz Moderna Therapeutics Vollzeit

    **The Role**: Moderna Therapeutics is seeking a Director of Regulatory Labeling to support new and existing programs to be based in Basel or other International Moderna hub. This is a newly created role intended for a forward looking, creative regulatory professional able to anticipate and address the challenges involved in swiftly delivering labeling for...


  • Basel, Schweiz Moderna Vollzeit

    **The Role**: The Sr. Director of Regulatory Process and Compliance position will work cross-functionally to drive activities that will ensure a state of continuous compliance at Moderna and build inspection-preparedness capabilities and sustain a positive compliance reputation between Moderna’s business partners, Health Authorities and cross-functionally...