Regulatory Affairs

3 weeks ago

Glasgow, United Kingdom Mentholatum UK Ltd Full time

Job title: Head of Regulatory Affairs
Position reports to: Director of QA and RA
Direct reports:
RA Manager (UK, EEA, EAEU, CIS)
RA Manager (Middle East)
Compliance Manager
Location : East Kilbride/hybrid
Employment status : Full time, permanent
Travel requirements : Occasional domestic/international travel may be required.
Other special requirements : Some knowledge of a second language preferable - Arabic
Overall purpose of the job
To oversee the Regulatory Affairs (RA) activities for all Mentholatum products in all territories to support the manufacture, importation, sale and supply of medicines, medical devices, cosmetics, and other product categories.
To formulate strategy and actions to assure successful initiation, management and maintenance of regulatory authorisations, through liaison with Competent Authorities, and contractors.
To provide a “one stop shop” for the Mentholatum business to use for regulatory advice and support, as well as coordination of training for key areas of the business in regulatory requirements.
To assure and maintain the compliance of the business with regulatory requirements.
To develop, maintain and assure interaction of the RA team with suitable systems to support progression and compliance.
Principal duties, deliverables and accountabilities
Principal duties:
To effectively manage the RA team resources: To assure that the RA team has the necessary training and support required to fulfil their roles.
To delegate tasks commensurate with their individual skill levels; including evaluation of workload, quality and metrics through regular review and reporting of findings.
To assure appropriate RA actions are taken within required timescales in support of the introduction of new products and registrations to help develop and grow the Mentholatum business.
To assure that all product registrations and certifications, including facility registrations, are maintained and compliant across the Mentholatum territories.
To effectively collaborate with all functional categories within the business:
To provide clear and consistent regulatory advice and information on registrations and activities To collaborate with functions on change management and compliance
To collaborate with NPD to develop innovative claims and formulations that will optimise routes to market. To provide sound regulatory strategy and advice to support Senior Management within the business.
Core responsibilities / deliverables:
Formulate RA strategy and complete regulatory activities to agreed schedules.
Oversee and/or contribute to regulatory submissions prepared by the regulatory team.
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
Key accountabilities:
Ensure principal duties are carried out accurately, professionally, in compliance and to schedule. Continually build upon and maintain knowledge base of global regulatory landscape, regulations, and guidance
Ensure monthly report is delivered in a timely manner.
Skills, knowledge, experience and qualifications required
Skills
Excellent written, oral and presenting skills
Ability to lead and work in a team with a strong sense of responsibility.
Ability to work effectively with senior management, remaining motivated and enthusiastic in times of change and other pressure situations.
Capability to professionally represent the department and the company both externally and internally. Knowledge
Extensive experience in pharmaceutical regulatory affairs and medical device legislation.
Experience of the regulatory environment in the territories covered by Mentholatum.
Experience of working in or with manufacturing, quality assurance, (pharmacovigilance), marketing and commercial. Experience of interfacing with Competent Authorities globally.
Experience
Broad experience and knowledge in the field of RA for medicines, medical devices and preferably also cosmetics.
Experience in defining and implementing RA Quality Management Processes.
Experience in interpreting and explaining regulatory concepts
Experience with proactively communicating and interacting directly with Competent Authorities. Senior executive level or greater in RA
Qualifications
Bachelor's Degree in Life Science or related discipline, advanced degree advantageous but not essential. Desirable MSc Regulatory Affairs or Medical Technology
Member of TOPRA
At least 10 years regulatory experience
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