HAYSScotland
you'll be joining a well established operation that offers a hugely diverse spread of work and projects.
• As an Associate Director, you'll be encouraged to pursue and develop work streams that you enjoy and explore niches within that field. You...
KILMARTIN MUSEUM COMPANY LTDScotland
heritage of Kilmartin Glen. They are seeking a Museum Director who will have overall responsibility for financial sustainability of the Museum through income generation, fund raising and marketing to ensure delivery of the Museum’s Mission Statement...
DPDHolytown
Startingyour own business as an Owner Driver with DPD has never beeneasier.With our Owner Driver Franchise scheme, you can run yourown business and share in the growing success of DPD.We give youall you need to get started.From your own van, the best tech inthe business and all the training to get y...
MM SearchScotland
MM Search are delighted to be working with Caledonia Housing Association on an Executive Director of Operations role. This Executive Director of Operations role follows a recent review of their Executive Structure, with the aim of enhancing...
GDK (German Doner Kebab)East Kilbride
are wholly owned subsidiaries of Hero Brands.
The North American operation is wholly by GDKI. Having opened the first restaurant in 2021, there are now 11 restaurants trading in North America with GDK now looking to make a step change in performance and has...
GdkEast Kilbride
Brands are wholly owned subsidiaries of Hero Brands.
The North American operation is wholly by GDKI.
Having opened the first restaurant in 2021, there are now 11 restaurants trading in North America with GDK now looking to make a step change...
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Head of Regulatory Affairs
Real Staffing | East Kilbride | Permanent | www.technojobs.co.uk |
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.
p>
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. p>
Position: strong> p>
• 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 li>
• Formulate strategy and actions to assure successful initiation, management and maintenance of regulatory authorisations, through liaison with Competent Authorities, and contractors li>
• 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 li>
• Assure and maintain the compliance of the business with regulatory requirements li>
• Develop, maintain and assure interaction of the RA team with suitable systems to support progression and compliance li> ul>
Duties: strong> p>
• Assure that the Regulatory Affairs team has the necessary training and support li>
• Evaluation of workload, quality and metrics through regular review and reporting of findings li>
• Support of the introduction of new products and registrations li>
• The Head of Regulatory Affairs will assure that all product registrations and certifications, including facility registrations, are maintained and compliant across territories li>
• Collaborate with all functional categories within the business li>
• Collaborate with functions on change management and compliance li>
• Collaborate with NPD to develop innovative claims and formulations that will optimise routes to market li>
• Provide sound regulatory strategy and advice to Senior Management li> ul>
Deliverables: strong> p>
• Formulate RA strategy and complete regulatory activities to agreed schedules li>
• Oversee and/ or contribute to regulatory submissions prepared by the regulatory team li>
• 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 li>
• Establish and maintain regulatory intelligence to best support the business li>
• Continually build upon and maintain knowledge base of global regulatory landscape, regulations, and guidance li>
• Ensure monthly report is delivered in a timely manner li> ul>
Skills: strong> p>
• Written, oral and presenting skills li>
• Lead and work in a team with a sense of responsibility li>
• Track record in pharmaceutical regulatory affairs and ideally medical device legislation (not a deal breaker) li>
• Regulatory exposure to environments in local and international territories li>
• Working in or with manufacturing, quality assurance, pharmacovigilance, marketing and commercial li>
• Interfacing with Competent Authorities li>
• Ability to travel as required li> ul>
Qualifications: strong> p>
• Either Degree in Life Science or track record in a similar position li>
• Member of TOPRA is desirable but a deal breaker li>
• Regulatory experience in Life Sciences (e.g. Consumer Health. Pharma, Biotech, Med Devices etc.) li> ul>
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 p>
p>
strong> p>
To find out more about Real please visit www.realstaffing.com strong> p>
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales p>
p>
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. p>
Position: strong> p>
• 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 li>
• Formulate strategy and actions to assure successful initiation, management and maintenance of regulatory authorisations, through liaison with Competent Authorities, and contractors li>
• 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 li>
• Assure and maintain the compliance of the business with regulatory requirements li>
• Develop, maintain and assure interaction of the RA team with suitable systems to support progression and compliance li> ul>
Duties: strong> p>
• Assure that the Regulatory Affairs team has the necessary training and support li>
• Evaluation of workload, quality and metrics through regular review and reporting of findings li>
• Support of the introduction of new products and registrations li>
• The Head of Regulatory Affairs will assure that all product registrations and certifications, including facility registrations, are maintained and compliant across territories li>
• Collaborate with all functional categories within the business li>
• Collaborate with functions on change management and compliance li>
• Collaborate with NPD to develop innovative claims and formulations that will optimise routes to market li>
• Provide sound regulatory strategy and advice to Senior Management li> ul>
Deliverables: strong> p>
• Formulate RA strategy and complete regulatory activities to agreed schedules li>
• Oversee and/ or contribute to regulatory submissions prepared by the regulatory team li>
• 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 li>
• Establish and maintain regulatory intelligence to best support the business li>
• Continually build upon and maintain knowledge base of global regulatory landscape, regulations, and guidance li>
• Ensure monthly report is delivered in a timely manner li> ul>
Skills: strong> p>
• Written, oral and presenting skills li>
• Lead and work in a team with a sense of responsibility li>
• Track record in pharmaceutical regulatory affairs and ideally medical device legislation (not a deal breaker) li>
• Regulatory exposure to environments in local and international territories li>
• Working in or with manufacturing, quality assurance, pharmacovigilance, marketing and commercial li>
• Interfacing with Competent Authorities li>
• Ability to travel as required li> ul>
Qualifications: strong> p>
• Either Degree in Life Science or track record in a similar position li>
• Member of TOPRA is desirable but a deal breaker li>
• Regulatory experience in Life Sciences (e.g. Consumer Health. Pharma, Biotech, Med Devices etc.) li> ul>
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 p>
p>
strong> p>
To find out more about Real please visit www.realstaffing.com strong> p>
Real Staffing, a trading division of SThree Partnership LLP is acting as an Employment Agency in relation to this vacancy| Registered office | 1st Floor, 75 King William Street, London, EC4N 7BE, United Kingdom | Partnership Number | OC387148 England and Wales p>
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