Head of Regulatory Affairs, Cmc

vor 2 Wochen

Basel, Schweiz Barrington James Vollzeit

Basel, Switzerland
- 15-06-2023
- JOB TYPE
- Permanent
- EMP TYPE
- Full-Time
- EXPERTISE
- Regulatory Affairs
- SALARY TYPE
- Annually
- SALARY
- Negotiable

Position: Head of Regulatory Affairs, CMC & Drug Substances

**Responsibilities**:

- Establishing and implementing the corporate Regulatory Affairs and CMC development standard across multiple sites.
- Ensuring regulatory compliance and maintaining registration files for regulated products, including post-approval change management.
- Developing CMC and regulatory strategies for new drug substance projects in collaboration with customers and internal/external development groups.
- Guiding system owners in the preparation, submission, and maintenance of regulatory documents such as DMFs, CMC documentation for INDs, IMPDs, NDAs, MAAs, etc.
- Providing hands-on support in implementing and ing the corporate standard at various sites.
- Coordinating regulatory activities during CMC process development for corporate projects and providing regulatory guidance to CARBOGEN AMCIS and customer project teams.
- Acting as a Subject Matter Expert in audits and inspections and leading the corporate RAC organization within the Quality Organization.
- Owning and maintaining the RAC chapter in the Corporate Management Handbook to define and uphold a harmonized RA standard.
- Managing the e-CTD submission software.

**Requirements**:

- Ph.D. in Chemistry, Pharmacy, or equivalent scientific field.
- Strong knowledge of Regulatory Affairs & CMC (drug substances and/or drug products) and CMC development.
- Good understanding of GMP regulations.
- Familiarity with e-CTD systems.
- Minimum of 5 years of experience in an RA department (Drug Substances or Drug Products).
- Minimum of 5 years of work or management experience in an RA/GMP environment.
- Minimum of 5 years of experience in dealing with authorities and customers.
- Minimum of 5 years of leadership or consultancy experience.
- Good intercultural skills.
- Excellent communication skills in English, both oral and written.
- Flexible working attitude, including readiness for overtime work.
- Strong team-oriented leadership skills with excellent decision-making capabilities.
- Service-oriented mentality.

**Benefits**:

- A dynamic work environment with high-quality infrastructure.
- Opportunities for professional skill development.
- Flexible working hours based on a 40-hour week.
- At least 5 weeks of vacation.
- Participation in childcare costs.
- Travel insurance for private trips.
- Private insurance coverage for accidents.
- 13th monthly salary paid out without any social benefit deductions, with potential profit sharing in successful business years.

LI-TS2

Consultant
- Tomas Swithenbank
- +441293776644

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