Description
Regulatory Affairs Manager- Switzerland - 6 monthsOur client, a research-based biopharmaceutical company that discovers, develops and commercialises innovative medicines is currently looking for a Regulatory Affairs Manager. You will be responsible for leading and working on major regulatory submissions and acting as the QP.
Requirements
- Expert in local regulatory affairs and quality systems and have previously worked extensively within the Pharmaceutical industry Proven track record in biocide / biocidal product regulatory affairs / registrations
- PhD or Masters in Pharmaceutical Sciences or equivalent
- Experience in working for the Swiss market is highly desired
- Very good written/spoken English in addition to fluent German
- Proven experience in project planning with administrative and organizational skills
- Excellent communicator, both verbal and written.
Duties and Responsibilities will include
- Prepare and or manage technically complex submissions and manage cross functional reviews required for a successful submission
- Responsible for submitting of all regulatory documents required to obtain marketing authorizations for assigned product(s). Preparation and submission of new MAAs, eCTD Format, Life Cycle Management of commercial products; filing of new indications, line extensions, CMC and labeling variations
- Represents Regulatory Function at internal and external meetings. Works proactively to build contacts with local Regulatory Authorities and build upon an existing network of regulatory contacts
- Responsible for ensuring responsibilities of Applicant and/or License Holder defined in legislation or regulatory guidance are met for assigned product(s)
I am a specialized recruiter, currently taking care of various projects within the Regulatory Affairs area in Switzerland. For more information about this role or jobs within related specialist areas please send me your CV as a Word document with your hourly rate expectations for immediate consideration.
You can reach me on or at (a.xenitidis'at'realstaffing.com)
Keywords: Regulatory Affairs Manager, Regulatory Affairs, temporary, Switzerland, freelance, English, German