Reference Number: JO-2004-448587
Head of Regulatory Labelling
Job Type: Permanent
Role: Head of Regulatory Labelling
Employment: Permanent, Full Time
Our client is a global pharmaceutical company committed to setting new standards in healthcare. They offer a growing portfolio of more than 7,500 products, including prescription generic, branded generic, brand-name and biosimilar drugs, as well as over the counter (OTC) remedies. In this role you will be responsible for providing leadership to the Central Regulatory Affairs (CRA) Labelling Team, and support labelling activities for EU and non-Eu regions for Marketing Authorisation Application and subsequent lifecycle management, and any other labelling activities.
Lead CRA Labelling Teams across multiple locations. Set objectives, conduct mid-year and end-year reviews, and ensure training, development and coaching of team members in order that they meet the team and individual objectives.
Ensure Product Information texts for procedures managed by CRA are prepared to a high standard and on-time according to agreed company procedures and objectives. Support team members by reviewing texts intended for submission and advise Senior Management regarding any deficiencies or issues.
Offer Subject Matter Expert support to Head of Labelling and Regional Support – Europe, CRA Labelling Teams, and other Stakeholders, with initiatives which impact, or may impact, Labelling activities within the region (including the National markets) to ensure that proposed, or on-going, activities consider relevant Legislation and guidance etc.
Represent the CRA Labelling teams during internal or external inspections and audits.
Assemble regular Global Labelling Committee meetings, acting as Chair, making and implementing decisions affecting Labelling activities within the region.
Guide Head of Labelling and Regional Support – Europe of the status and progress of department performance management and functional KPIs, identifying potential problems or delays, and possible solutions, as they occur and maintain a status report for these activities.
Ensure compliance of the CRA Labelling team to relevant SOPs and guidance documents etc.
Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities). Use this information to influence, change and optimise departmental procedures and processes.
Knowledge, Experience & Skills:
Eligibility to work in the UK
At least 15 years experience in the Pharmaceutical Industry preferably within a Regulatory, Product Safety and/or Labelling environment. However, a combination of experience and/or education will be taken into consideration.
Must have at least 5 years functional management experience.
Must understand the requirements for the submission, approval and implementation of labelling and artwork for pharmaceutical product labelling throughout the EU region and have an awareness of the updates required throughout the product lifecycle.
Strong organisation and communication skills with broad business awareness and the ability to interact at all levels of the organization.
Must be able to review, interpret, and discuss governing regulations, precedent interpretations, and documentation.
Must be adept at data analysis, pay keen attention to detail and possess a strong commitment to continuous improvement.
Must be proficient in leading discussions of complex topics.
Must be able to respond to common enquiries or complaints from customers, regulatory agencies, or members of the business community.
Must have a working knowledge of Microsoft Office and Outlook. Project management experience preferred.
If you are interested in discussing this role further, then please email your CV to firstname.lastname@example.org or call Amani on 01189 522 797 to arrange a confidential discussion.
If you are not currently looking but know someone who would be good for this role then get in touch. We offer a referral scheme at Regulatory Professionals where in which a successful recommendation will earn you 250 worth of vouchers *terms and conditions apply*.