Job Title

Regulatory CMC Manager (Liaison), Basel

Salary

£46,000 - £59,999

Job Type

Registration

Location

Switzerland

Employment Type

Permanent Job

Employer Type

PM Pharmaceutical R&D HQ (Global Or EU)

Seniority

Senior Executive/Team Leader

Duration

 

FTE Hours

Full Time 35 - 40hrs Per Wk

Vacancy Status

Open For Applications

Date Posted

Fri 10th Oct 2008, 04:06pm

A permanent position located within the global HQ of this top 5 R&D Company

Formulate, lead and drive regional and/or global CMC regulatory strategy for assigned development projects and/or marketed products with a focus on creativity and innovation, maximizing the business benefit balanced with regulatory compliance.

Proactively provide strategic input and communicate critical topics in adequate and timely manner to interdisciplinary project teams and to appropriate management level.
Lead, implement and drive CMC submission activities (planning, review, coordination, submission) for assigned projects/products. Make quality regulatory decisions as necessary, balancing risks and benefits.
Represent Regulatory CMC in interdisciplinary regulatory and technical project teams.
Establish and maintain a single point of contact with internal and external partners and customers for all communication on development projects and marketed products. Establish and maintain sound working^relationships with partners and customers.
Lead cross-functional Health Authority response teams for assigned development projects / marketed products, as appropriate.

Minimum requirements/Education and/or professional experience:

Relevantscientific degree in pharmacy, chemistry, biotechnology, biochemistry, biology or equivalent.

Languages:
Fluent English required (oral & written).

Experience / Professional Requirements:
Several years of experience in regulatory preferred^
Excellent working knowledge/experience in regulatory submissions and approval processes for New Chemical Entities (NCE) and product life cycle management and proven practical knowledge of and ability to deal with complex CMC regulatory issues andrequirements
Proven track record in successfully leading/working in interdisciplinary teams, and of planning, coordinating and leading activities simultaneously on multiple projects.
Strong interpersonal, organizational, communication, presentation, negotiation and problem solving skills.