Regulatory Expert

For our medical device client in Schaffhausen, we are looking for a Regulatory Expert for a contract role.

Responsibilities:

*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 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
*Partner with Global Regulatory groups to coordinate and ensure submission of filings for US and/or other countries and/or regulatory activities
*Partner with Production, Chemical and Analytical Development, Quality Control, Quality Assurance and other departments as needed

Required skills:
*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.
*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 behavior that understands what the priorities are and encourages others to drive for results will be needed.
*Knowledge in German is preferred but not absolutely required

Would you like to apply for this job opportunity?
Please send me your updated CV Kaja Nash or feel free to contact me.
I am looking forward to hearing from you.