Regulatory CMC Associate Manager, Contract, Switzerland

For our large multinational SWISS PHARMACEUTICAL CLIENT, we are currently searching for a REGULATORY CMC ASSOCIATE MANAGER to work in BASEL, Switzerland and provide timely preparation of high quality CMC regulatory documentation and support to contribute to global regulatory submissions and strategies.

Please see below for requirements of the role:

EDUCATION (minimum/desirable):

Minimum:

Degree in Science (eg Chemistry, Pharmacy, Biochemistry, Biotechnology, Biology) or equivalent

Desirable:

Advanced Degree in Science (Chemistry, Pharmacy, Biochemistry, Biotechnology) or equivalent.

LANGUAGES:

Fluent English required (oral and written). Good skills in site (local) language desired (oral)

EXPERIENCE/PROFESSIONAL REQUIREMENT:

- 0-4 years in regulatory preferred, and/or experience in drug/biopharmaceuticals
- Working knowledge of chemistry/biotechnology, analytics or pharmaceutical technology. Knowledge of the drug development process desirable. Ability to critically evaluate data from a broad range of scientific disciplines.
- Knowledge/experience of regulations, guidelines for NCEs and product life cycle maintenance desirable.
- Ability to work successfully with extended, multinational project teams and coordinate activities simultaneously on multiple projects under pressure of time and workload.
- Effective planning, organizational and interpersonal skills.
- Reasonable approach to risk assessment.
- Excellent written/spoken communication and negotiation skills.
- Computer literacy.

We welcome applications of consultants' who match most of the above requirements and are available on a short notice. There is a COMPETITIVE HOURLY RATE AVAILABLE for the contract, alternative market rates are also welcome. Please note there is a job description available on request.

We hope the role will be of interest to you and understand that further information may be required before making an application to the end client, please feel free to send either your full name, contact details or a complete CV via this website and I will endeavour to get back to you with further information on the role and answer any questions you may have.

Kind regards,

Neha Sharma

MBA Michael Bailey Associates

Job Code: 109148

Key words: Regulatory affairs, drug development, CMC, biopharmaceutical, pharmaceutical, biotechnology, risk assessment, project management, quality, HA, dossiers, registration, documentation, regulations, NCEs, product life cycle management, drug, Switzerland, English

Michael Bailey International is acting as an Employment Business in relation to this vacancy.