For our Life Sciences client in Switzerland, we are currently seeking for a Regulatory Expert - CMC:
Job title: Regulatory Expert - CMC
Start date: ASAP
End date: 31/03/2017
Location: Schaffhausen, Switzerland
Languages: Good knowledge of English. Knowledge in German is preferred but not absolutely required
- Active Substance Master File, Drug Master File, Certificate of Suitability (CEP) Submissions: Coordination and preparation for new submissions, regular updates, variations, renewals
- Customer communication (prior and after submission of regulatory filings and/or filing updates filing)
- Collaboration with customers to develop and align regulatory filing strategies and implementation plans
- Sunrise project: Regulatory actions, eg customer communication, filing renewals, filing transfers, filing withdrawals
- Coordination and preparation of responses to deficiency letters or authority requests
- Coordination and preparation of responses of customer requests related to filings and or other regulatory/technical questions or questionnaires
- Preparation and submission of Open Parts, Letter of Access, TSE Statement, Kosher/Halal Statement, Allergens Statement, Melamin free Statement, Latex free Statement, etc.)
- Regulatory consultation for Quality Assurance, Production, Quality Control, Sales, Purchasing
- Preparation of FDA-GDUFA (Generic Drug User Fee Amendments) applications
A minimum of a Bachelor's degree with a minimum of 6+ years of relevant experience in a highly regulated environment (preferably pharmaceutical industry) or an advanced degree (MS, PhD, etc.) with a minimum of 4+ years of experience is required.
- Regulatory CMC or CMC experience is preferred.
- Basic knowledge of regulatory requirements is preferred.
- Drug development experience is preferred.
- A working knowledge of global HA laws, regulations, and guidance is required.
- Experience developing regulatory strategies and an understanding of product development is preferred.
- Solid understanding of chemistry relevant is preferred.
- A demonstrated ability to communicate regulatory requirements is required.
- Excellent interpersonal, teamwork and verbal/written communication skills will be needed.
- Good organizational skills and an ability to manage multiple tasks/projects/priorities and complex systems simultaneously will be needed.
- Communicates cross-functionally and cross-company as well and presents and defends regulatory strategy and opinion to project teams.
- Ability to demonstrate model behaviour that understands what the priorities are and encourages others to drive for results will be needed
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.
We hope that the role will be of interest to you and understand that further information may be required prior to an application to the end client, please feel free to email or call me at anytime with any questions you may have.
Thank you for your time and we hope to hear from you soon.
Pharmaceutical & Life Sciences Business Developer
Recruiting Team MBA,
Michael Bailey Associates
Michael Bailey International is acting as an Employment Business in relation to this vacancy.