Head of Regulatory Affairs, Cmc - Basel, Schweiz - Barrington James

Barrington James

Geprüftes Unternehmen

Basel, Schweiz

vor 3 Wochen

Geschrieben von:

Lena Schneider

beBee Recruiter

Basel, Switzerland

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 postapproval 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 handson 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 eCTD submission software.

Requirements:

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 eCTD 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 teamoriented leadership skills with excellent decisionmaking capabilities.
Serviceoriented mentality.

Benefits:

A dynamic work environment with highquality infrastructure.
Opportunities for professional skill development.
Flexible working hours based on a 40hour 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.

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