Pharmaceutical Regulatory Expert

REGULATORY AFFAIRS SPECIALIST

Dear Regulatory Affairs Specialist,

I'm on the hunt for a Regulatory Affairs specialist to join my international pharmaceutical client in Schaffhausen until March 2017 with a possibility for extension.

In this regulatory function you will perform and support the following activities to ensure regulatory filing compliance:

- 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
- 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 assessments of Change Requests and development of regulatory implementation plan
- Regulatory assessment of major Non Conformances
- Regulatory consultation for Quality Assurance, Production, Quality Control, Sales, Purchasing
- Preparation of FDA-GDUFA (Generic Drug User Fee Amendments) applications
- Regulatory support for inspections and audits
- Ensure regulatory filing compliance and continued life cycle management

REQUIREMENTS:

- 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.
- Good knowledge of English.
- 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.
- Knowledge in German is preferred but not absolutely required

If you're up for a new role and fulfil the requirements, click on the apply button!

I look forward hearing from you
Charlotte