CMC Regulatory Affairs - 12 Months - Pharmaceuticals

JOB TITLE

Regulatory Affairs Manager - 6 Months - Biotechnology

THE COMPANY

One of the top Biotechnology companies in the world. The organisationis seeking a full-time contract position based in their Uxbridge Office.

LOCATION

West London, UK

SALARY

£47-£52 per hour

ROLE/DESCRIPTION

The Regulatory Professional will play a key role in developing and executing CMC regulatory strategies for new marketing authorisation applications and throughout whole product lifecycle for the European and extended European region.

KEY TASKS

• Ensuring CMC regional issues impacting global regulatory strategy for proposed CMC
• Filings are considered and risks identified with appropriate contingency strategies
• Review the preparation of M2 and 3 CMC components of filings and assess fitness of purpose for submission in the relevant countries
• Manages Strategy and Execution for all regulatory submissions (e.g. clinical trial and variations)
• Authoring and coordinating responses to questions across assigned products and countries.
• Point of Contact with local country regulatory staff
• Project management of submissions and monitoring status of applications
• Communicate regional needs for ensuring reliability of the supply chain and successful launch are well defined and implemented in collaboration with relevant regional stakeholders
• Ensure regulatory product compliance for product (e.g. IMR, PMCs, paediatric and other agency commitments)
• Share regulatory information and implications with the stakeholders on an ongoing basis and provide advice on regional considerations
• Performs regulatory research to obtain relevant histories, precedence and other information relevant to regional product advancement.
• Provides guidance for regulatory assessments of change control requests
• Sets project timeframes and priorities for products under their responsibility based on project objectives and ongoing assignments; raises resource constraints
• Document and communicate details and outcomes of regulatory agency interactions to global regulatory and operations teams and relevant sr. management

KEY SKILLS

• Regulatory knowledge in regional legislation
• Russian Marets Knowledge
• Working with policies, procedures and SOPs
• Experience with national legislation and regulations relating to medicinal products
• Understanding of the regional regulatory procedures for CTAs, MAs, post approval changes, extensions and renewals.
• Understanding of drug development Scientific / Technical Excellence
• Strong knowledge of and experience in regional regulatory environment in relevant product area and development stage
• Ability to resolve conflicts and develop a course of action leading to a beneficial outcome
• Cultural awareness and sensitivity to achieve results across both regional country and International borders.
• Strong team player with a commitment to customer service
• In-depth experience of pharmaceutical/biotechnology or medical device industry
• Strong record of related experience within Regulatory Affairs (min 5 years)

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the Pharmaceutical industry in the UK and Europe. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY:
If you would like to discuss this vacancy further, please call the Global Strategic Delivery Consultant Billy Twomey on +44 (0)2031890460 or +31 (0) 208081504 or email at btwomey@i-pharmconsulting.com. If this role is not suitable, Billy is also available to discuss other possible positions or answer any general questions regarding your career and the current market.

KEY WORDS
Quality Assurance / QA / Quality Assurance Specialist / Biopharmaceutical / Dun Laoghaire / Contract / Pharmaceuticals / Pharma / Ireland /