On behalf of our client, a global pharmaceutical company, we are currently recruiting for a Senior Manager, Core Labelling Strategy. This is a permanent, full-time role. This is a hybrid role with approx 3 days a week in the North Dublin office.
Role
The position provides regulatory labelling leadership, governance, and expertise to company products such that the Product Information texts (labelling) of existing and new products are successfully developed and maintained globally.
In this role the individual will have responsibility for the development, creation, and maintenance of compliant Core Labelling documents including Global Ad Promo review and approval, in alignment with company principles and procedures.
- Accountable for management of the labelling process and labelling development.
- Leads development, preparation, review and approval of global labelling documentation (e.g. Target Product Label, 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 TPL, 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.
- Chairs Product Labeling Team, ensuring appropriate membership by addressing need for ad hoc members from supportive functions as necessary and Working with Global Medical and Clinical Services and Global Product Safety and Risk Management (PSRM) – Safety Surveillance as well as Clinical Safety Team contact to ensure that the content of PI texts authored is verified and agreed with respective disciplines. 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 company 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).
- Reviews and approve promotional materials with respect to CCDS and relevant code of conduct according to company requirements and processes and counsels strategic review of competitor and existing Labeling documents, as necessary.
- 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.
Requirements:
- Bachelor’s degree in science/medicine/pharmacy (or related field) with extensive years of experience, including many years in labelling; advanced degree preferred.
- Prior leadership experience or willingness to lead direct reports.
- Strong regulatory background, including in-depth labelling knowledge and understanding of GLC, EU, and US regulatory requirements.
- Excellent interpersonal, presentation, and communication skills with ability to influence in a matrixed, cross-functional environment.
- Ability to provide innovative, compliant labelling recommendations aligned with corporate goals.
- Ability to work autonomously and potentially supervise employees in line with organizational policies and laws.
- Ability to interpret complex research, write scientific/technical documents, and communicate abstract concepts to senior leaders.
- Strong analytical and reasoning skills to solve moderately complex problems and draw inferences.
- Proficiency with basic mathematical computations (percentages, ratios, rates).
For a full Job Spec and to apply for this role please call Linda on 01 2784703 or e-mail [email protected]