For our pharmaceutical partner, Kelly Scientific is looking for a
 
Regulatory Affairs Manager - English fluent
 1 year contract - 100 %

 
Mission

 In this role an individual...

Regulatory Affairs Manager - English fluent 1 year contract - 100 %

For our pharmaceutical partner, Kelly Scientific is looking for a
 
Regulatory Affairs Manager - English fluent
 1 year contract - 100 %

 
Mission

 In this role an individual may also manage a small team for which they will set a compelling vision and deliver against the sub-category strategy and mission. The role may require the individual to provide specialist regulatory advice across the Category and Function.
 
Key responsibilities

• Acts as a Business Partner and provides regulatory advice across a brand or subset of products on aspects of drug/cosmetic/devices/food and supplements (dependent on category) development and regulatory requirements as appropriate.
• Develops novel regulatory strategies and influences approaches within Project Teams in order to secure competitive approvals and speed to market in conjunction with LOC regulatory teams.
• Communicates effectively within the function at all levels and within cross-functional Project Teams.
• Plans, prepares and delivers high quality regulatory files to agreed timelines.
• May lead non-product related activities within the function and input cross functionally, in order to direct new policy or pioneer new processes or improvements to GSK's competitive advantage.
• May act as GSK representative to external groups on specific task forces within their field of expertise.
• Support the development of the strongest claims possible aligned to consumer insight and within the regulations, ensuring risks are appropriately addressed and communicated within Project Team.
• In conjunction with the category regulatory CMC lead, ensure support for the full life cycle of products, including: maintenance activities; Design to Value, complexity reduction, value engineering initiatives; change controls, etc. with supply chain and technical excellence.
• Ensures compliance of their actions by adhering to global, regional and local processes, policies, SOPs and working instructions.
• Medical Device Technical File (MDTF) creation and maintenance through Periodic Review as described in GSK Quality System.
• MDTF update in case of changes (both significant and non-significant), unless the change is under RA CMC or RA globalization groups scope. Includes labelling texts and instructions for use for Medical Devices updates.
• Risk management prior or post CE Marking: ownership and coordination of risk management activities with inputs from other functions.
• Generation, review, approval and maintenance of MDTF within Consumer Healthcare electronic document management system (eDMS) or following the requirements defined by Quality System
• Communication with Notified Body, including initial MDTF and significant changes submissions, coordination of answers to questions from Notified Body / Competent Authorities / Health Authorities
• Representation of GRA during audits with MDTF or Medical Devices Regulatory activities in scope.

 
Your profile

• Degree in Science (e.g. Chemistry, Pharmacy) or equivalent
• 4-8 years' experience in Pharmaceutical regulatory affairs
• Fluent in English
• Strategic experience for products and experience of Health Authorities meetings
• Strong attention to details and organizational skills required
• Good written and oral communication, technical writing and editing skills
• Able to work independently with minimal supervision.

 
If you think your profile fits to this position, don't hesitate to apply online on the Kelly Services website and it will be a pleasure for us to consider your interest.
 
Your contact at Kelly Scientific:
Amina OUMEZIANE
Consultant Professional Staffing Life Science