Head of Corporate Regulatory Affairs & CMC (RAC)
As part of our growth strategy and succession planning, we offer a new challenge a Senior Manager Corporate Regulatory Affairs at our site in Bubendorf, Switzerland. You will be a member of the Corporate Quality Organization responsible for Regulatory Affairs & CMC. You will elaborate and maintain the corporate RAC development standard in cooperation with the local regulatory affairs and CMC teams of the three Business Units (Drug Products; Drug Substance and Biologics & ADCs); Specialties for in total 8 sites and monitor its compliant execution. You act as a Business Process Owner for the corporate regulatory affairs systems like the e-submission software and the monitoring of the applicable regulation and guidelines. You provide regulatory affairs advise and hands-on support for local regulatory affairs internal improvement- and customer projects as required.
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.
For further information please contact the Human Resources department.
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