An excellent opportunity has arisen for an experienced Regulatry Affairs Labelling Manager to join my clinet, a global pharmaceutical company, based in Hertfordhsire. This is a largely remote based role, with the requirement to visit the office only twice each month.
Key responsibilities for this role include:
- Accountable for management of the labelling process and labelling development.
- Leads preparation, review and approval of global labelling documentation (e.g. CCDS, Core Patient Information) as well as territorial labelling documentation (e.g. Common EU SmPC?s and USPI?s) based on clinical and non-clinical dossier to support regulatory filings for submission to international regulatory agencies
- Leads labelling strategy in partnership with Global Regulatory in line with the overall regulatory Strategy by providing labelling expertise (labelling regulations, internal processes, and impact analysis of competitor profiles) for CCDS, USPI (including Abbreviated New Drugs Applications, New Drug Applications and Biologics License Applications) and group managed EU SmPC?s (Centralized / Mutual Recognition / Decentralized Procedures) as well as abbreviated PIs thereof
- Establishes close partnership of labelling leads with project leads and the regulatory matrix to ensure effective, strategic, and proactive labelling development. Interfaces directly with senior management, functional experts, on business strategy and labelling content
- Works closely with the aligned Regulatory Strategist and any other stakeholder teams as needed to lead all labelling aspects for the defined portfolio
- Leads labelling updates and development, critically evaluating the data and principles upon which labelling statements are based to ensure clinical relevance and regulatory acceptance across the portfolio
- Working with Global Product Safety and Risk Management ? Safety Surveillance Team contact to ensure that the content of PI texts authored is verified and agreed with the Safety Surveillance Team. Where agreement cannot be reached, escalation of the issue to Global Labelling Committee (GLC) for endorsement of recommendations.
- Commercially astute, with a strong understanding of competitor labels and evolving external labelling trends and agency requirements
- Negotiates resolution of complex regulatory and scientific issues, manages multiple projects simultaneously and employs sound judgment in solving complex problems
- Internally, influences key proposed guidelines and regulations to shape external environment
- May be active in external facing activities and is effective at representing the client in various industry groups (such as e.g., DIA, Navitas, trade associations) or at EMA (European Medicines Agency)- or FDA-sponsored events (e.g., Workshops, Ad Coms)
The minimum qualifications for this role are:
- Minimum of a Bachelor's degree (or equivalent) in Science, Medicine or Pharmacy, or another related field with 7-10 years of experience and 5 or more years of Labelling and Labelling development experience. Preferred candidate will Master's Degree, PharmD, or PhD in Science, Medicine, or Pharmacy. However, a combination of experience and/or education will be taken into consideration
- Prior leadership experience with direct reports or willingness to lead others. Regulatory experience including in-depth Labelling knowledge. Understand GLC requirements/ processes and EU/ US regulatory requirements
- Might need to manage direct reports, recruit, and motivate within the Labelling team. Contribute to the leadership of the Labelling Organization and drive effective governance through the GLC processes
- Highly developed interpersonal, presentation and communication skills. Ability to provide innovative approaches/recommendations to product labelling that meet corporate goals while maintaining compliance with relevant laws and regulations.
- The ability to influence effectively in a matrixed, cross-functional team environment
- Position functions autonomously. The position may directly supervise employees. Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities may include interviewing, hiring, and training employees; planning, assigning, and directing work; appraising performance; rewarding and disciplining employees; addressing complaints and resolving problems
For further details, please contact Tim Barratt on +44(0)1727 817 626 or email tbarratt@achieva.co.uk
- Agency: Achieva Group Limited
- Reference: BH-34650
Website: Achieva Group Limited
- Posted: 19th May 2023
- Expires: 16th June 2023
