Head of Regulatory Affairs

vor 1 Woche

Bubendorf, Schweiz CARBOGEN AMCIS Vollzeit

**Department**:Regulatory Affairs
- **Hours**:Full-time
- **Location**:Bubendorf, SwitzerlandAs part of our growth strategy and succession planning, we offer a new challenge as **Head of Regulatory Affairs & CMC (RAC)** at our site in Bubendorf, Switzerland. You will be responsible for all regulatory activities over all sites of **CARBOGEN AMCIS**. You will elaborate the corporate Regulatory Affairs and CMC development standard and assure its compliant execution together with your team of total ten professionals representing Regulatory Affairs CMC Drug Substances and Drug Products as well as ADC / bio-conjugates.
- **Your responsibilities**:

- Ensuring the internal standard in the regulatory compliance maintenance of the regulated products under consideration of customer requirements.
- Maintaining CGAM owned registration files and support customers in maintaining the files, which includes the post approval change management.
- Developing the CMC and regulatory strategy for new drug substance projects with customers and internal and external development groups as requested by the customer and consulting the customer and the internal project team.
- Guiding system owners through the issuance, submission and maintenance of all regulatory documents (DMF’s, CMC documentations for INDs, IMPDs, NDAs, MAAs, etc.).
- Coordinating the regulatory activities 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
- Acting as a Subject Matter Expert in audits and inspections and 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 RA 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

If you have questions please feel free to contact Ms. **Sabrina Peinal, Senior Head of Global HR** tel. +41 58 909 0741 with any questions.
- CARBOGEN AMCIS is a leading service provider in the area of product and process development, including the commercial production of active ingredients for the pharmaceutical and biopharmaceutical industries. We have 4 facilities across Switzerland (Aarau, Hunzenschwil, Bubendorf, and Vionnaz), as well as locations in Riom, Saint-Beauzire (FR), Manchester (UK), Shanghai (CN) and Veenendaal (NL). Our success is based on the high professional and personal competence of our employees.

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