Director of Regulatory Affairs Cmc - Basel, Schweiz - Proclinical

Proclinical

Geprüftes Unternehmen

Basel, Schweiz

vor 4 Wochen

Geschrieben von:

Lena Schneider

beBee Recruiter

Beschreibung

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.
Knowhow of RAC such as drug substances and/or drug product or CMC development.
Expertise on GMP.
Prior involvement in eCTD 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