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Regulatory Affairs Medical Device - East Kilbride, South Lanarkshire, United Kingdom - Real Staffing Group
Description
Our client founded in 1889 grew into a global health and wellness company providing Pharmaceutical, OTC and medical device products to the market.
A world leader in manufacturing and marketing of pharmaceuticals, cosmetics, skin care and health care products they have operations in 12 major markets, with marketing and distribution agreements in more than 130 countries.
Driven by scientific research, technology, and keeping a pulse on consumers' aspirations, the global teams are dedicated to providing effective solutions for customer needs through developing high quality, innovative new products.
To ensure continuity they are looking to add a Head of Regulatory Affairs to the team. The position will report to a Director of QARA and manage a team.Position:
Oversee the Regulatory Affairs (RA) activities for all products in all territories to support the manufacture, importation, sale and supply of medicines, medical devices, cosmetics, and other product categories
Formulate strategy and actions to assure successful initiation, management and maintenance of regulatory authorisations, through liaison with Competent Authorities, and contractors
The Head of Regulatory Affairs will provide a "one stop shop" for regulatory advice and support, as well as coordination of training for key areas of the business in regulatory requirements
Assure and maintain the compliance of the business with regulatory requirements
Develop, maintain and assure interaction of the RA team with suitable systems to support progression and compliance
Duties:
Assure that the Regulatory Affairs team has the necessary training and support
Evaluation of workload, quality and metrics through regular review and reporting of findings
Support of the introduction of new products and registrations
The Head of Regulatory Affairs will assure that all product registrations and certifications, including facility registrations, are maintained and compliant across territories
Collaborate with all functional categories within the business
Collaborate with functions on change management and compliance
Collaborate with NPD to develop innovative claims and formulations that will optimise routes to market
Provide sound regulatory strategy and advice to Senior Management
Deliverables:
Formulate RA strategy and complete regulatory activities to agreed schedules
Oversee and/or contribute to regulatory submissions prepared by the regulatory team
The Head of Regulatory Affairs will mentor and encourage sharing of knowledge with the regulatory team to help build, establish, and maintain a strong regulatory presence
Establish and maintain regulatory intelligence to best support the business
Continually build upon and maintain knowledge base of global regulatory landscape, regulations, and guidance
Ensure monthly report is delivered in a timely manner
Skills:
Written, oral and presenting skills
Lead and work in a team with a sense of responsibility
Track record in pharmaceutical regulatory affairs and ideally medical device legislation (not a deal breaker)
Regulatory exposure to environments in local and international territories
Working in or with manufacturing, quality assurance, pharmacovigilance, marketing and commercial
Interfacing with Competent Authorities
Ability to travel as required
Qualifications:
Either Degree in Life Science or track record in a similar position
Member of TOPRA is desirable but a deal breaker
Regulatory experience in Life Sciences (eg Consumer Health. Pharma, Biotech, Med Devices etc.)
Although the position is based in Scotland there is some hybrid working on offer for those that can't make it to site daily - this can be discussed on a case by case basis
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | London, EC4N 7BE, United Kingdom | Partnership Number | OC#removed# England and Wales
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