Regulatory Affairs (RA) Consultant f/m
- Coordination and preparation for new submissions, regular updates, variations, renewals: Active Substance Master File, Drug Master File, Certificate of Suitability (CEP) Submissions:
- Collaboration and communication with customers to develop and align regulatory filing strategies (renewal, transfer, withdrawals) and implementation plans
- Coordination and preparation of responses to deficiency letters, authority requests, customer requests
- 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, major Non Conformances and development of regulatory implementation plan
- 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
- Partner with Global Regulatory groups to coordinate and ensure submission of filings for US and/or other countries and/or regulatory activities
- Bachelor's degree with 6+ years of Regulatory Affair experience in pharmaceutical industry or a MSc. /PhD. with 4+ years of experience.
- Strong Regulatory Affair experience
- Good knowledge of global HA laws, regulations, and guidance is required
- CMC experience is preferred
- Experience developing regulatory strategies and an understanding of drug product development is preferred.
- Solid understanding of chemistry relevant is preferred.
- Excellent interpersonal, teamwork and verbal/written communication skills.
- Good organizational skills and an ability to manage multiple tasks/projects/priorities and complex systems simultaneously
- Communicates cross-functionally and cross-company as well and presents and defends regulatory strategy and opinion to project teams.
- Good knowledge of English.