Job description / Role
Performs day-to-day activities related to organisation and submission of regulatory documents directly to the Health Authority. Manage a team of 4 people dedicated to the Regulatory Affairs.
European pharmaceutical company.
* USFDA filing: Compile, prepare and submit NDAs, ANDA to USFDA and their life cycle management (PAS, CBE30, annual report)
* EU filing: Compile, prepare and submit MA application via MRP, DCP, and nationally and their life cycle management (Variations application)
* Advice on a full range of regulatory compliance and scientific issues related to generics (including complex generics) and new drugs
* Reviewing high-quality CMC documentation for Clinical, Registration product development, and product life cycle management.
* Development of optimum regulatory submission strategies focusing on cost, speed, efficiency leading to successful and timely approval of products.
* Provide support with drug listing, facility registration, and guidance on meeting GDUFA or PDUFA requirement
* Create an eCTD format narrative for NDA and ANDA applications and submit it in eCTD format to the Agency.
* Assist in developing draft labelling for proposed and existing drug products.
* Review product labelling for compliance with regulatory guidelines.
Opportunity to join a European company and work on various premium quality products.
* Self-motivated and independent
* Excellent English skills (written + oral)
* A master's degree in life sciences or a technical field (master in pharmacy preferred)
* Regulatory experience in the industry (5-10 years preferred)
* Up-to-date knowledge of international, federal, and state guidelines
* Sound judgement
* Organisational and communication skills
* Attention to detail
About the Company
Michael Page is one of the world's leading professional recruitment consultancies, specializing in the placement of candidates in permanent, contract, temporary and interim positions with clients around the world.
The Group has operations in the UK, Continental Europe, Asia-Pacific and the Americas. In the Middle East we focus on the areas of:
Finance & Accounting Banking & Financial Services Procurement Property & Construction Engineering & Supply Chain Oil & Gas Technical and Engineering Human Resources Sales Marketing Technology Secretarial Executive Search Legal
The Group operates through 161 offices in 33 countries and employs over 5,000 employees worldwide.