Head of Regulatory Affairs
2 weeks ago
1 week ago Be among the first 25 applicants
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
- 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
- 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
- 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
- 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.)
- Seniority level Not Applicable
- Employment type Full-time
- Job function Legal
- Industries Research Services
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Head Of Regulatory Affairs
2 weeks ago
East Kilbride, South Lanarkshire, United Kingdom Real Staffing Group Full timeOur 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...
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Head of Regulatory Affairs
2 weeks ago
East Kilbride, South Lanarkshire, United Kingdom Real Full timeOur 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...
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Head of Regulatory Affairs
3 weeks ago
East Kilbride, United Kingdom Real Full timeOur 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...
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Regulatory Affairs
2 weeks ago
East Kilbride, South Lanarkshire, United Kingdom Real Full timeOur 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...
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Head of Regulatory Affairs
1 month ago
East Kilbride, South Lanarkshire, United Kingdom Real Staffing Full timeOur 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...
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East Kilbride, South Lanarkshire, United Kingdom Real Full timeOur client 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...
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Regulatory Affairs Manager
1 month ago
East Kilbride, South Lanarkshire, United Kingdom Real Staffing Full timeOur 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...
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Regulatory Affairs Manager
2 days ago
East Kilbride, United Kingdom Real Full timeOur client 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...
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Regulatory Affairs Manager
2 days ago
East Kilbride, United Kingdom Real Full timeOur client 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...
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Regulatory Affairs Manager
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Head of QARA
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South Yorkshire, United Kingdom Adecco Full timeWe are currently seeking a highly skilled and experienced QARA Manager to join our client's innovative organisation.In this company, you will play a key role in ensuring regulatory compliance for our client's Class III Orthopaedic products. The successful candidate will have a strong background working with Notified Bodies, technical file remediation and...