Description
We are looking for a
Regulatory Expert (m/f)
Reference: -en
Start: asap
Duration: 6 MM+
Place: in the Schaffhausen region
Branch: Herstellung von pharmazeutischen Spezialitäten und sonstigen pharmazeutischen Erzeugnissen
Your tasks:
- Ensure regulatory filing compliance as a basis to support the business for APIs manufactured at the client's site
- Manage Active Substance Master File, Drug Master File, Certificate of Suitability (CEP) Coordination and prepare for new submissions, regular updates, variations, renewals
- Customer communication (prior and after submission of regulatory filings and/or filing updates); collaboration with customers to develop and align regulatory filing strategies and implementation plans
- Perform regulatory actions, e.g. customer communication, filing renewals, filing transfers, filing withdrawals
- Coordination and preparation of responses to deficiency letters or authority requests or of responses to 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; provide regulatory consultation for Quality Assurance, Production, Quality Control, Sales, Purchasing
- Regulatory assessment of major non-conformances and regulatory support for inspections and audits
- Preparation of FDA-GDUFA (Generic Drug User Fee Amendments) applications and ensure regulatory filing compliance and continued lifecycle management
- Partner with Global Regulatory groups to coordinate and ensure submission of filings for US and/or other countries and/or regulatory activities for products manufactured in Schaffhausen
Your qualifications
- Bachelor's degree with profound relevant experience in a highly regulated environment (preferably pharmaceutical industry) or an advanced degree (MS, PhD, etc.) with in-depth experience
- Regulatory CMC or CMC experience is preferred and basic knowledge of regulatory requirements is required
- A working knowledge of global HA laws, regulations, and guidance is required
- Experience in developing regulatory strategies and an understanding of product development is beneficial
- Solid understanding of relevant chemistry processes and drug development experience is preferred
- A demonstrated ability to communicate regulatory requirements
- Excellent interpersonal, teamwork and verbal/written communication skills
- Good organizational skills and an ability to manage multiple tasks/projects/priorities and complex systems simultaneously
- Ability to communicate cross-functionally and cross-company and ability to present and defend regulatory strategy and opinion to project teams
- Business fluent in English, German skills are beneficial
Skills:
- Regulatory affairs manager
Keywords: Regulatory Affairs Manager