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Global Head Of Regulatory Affairs, Pharmaceuticals
1 month ago
Global Head of Regulatory Affairs, Pharmaceuticals Key points: Our client is keen to speak with senior regulatory affairs professionals with strong leadership skills - there are a number of direct reports into this global role International regulatory markets experience is essential Entrepreneurial, commercial and growth mindset required There will be some travel required Hybrid working environment, 3 days required on-site in Dublin Overseas candidates with all of the above (and below) experience and a permit to work in Ireland will be considered.
A relocation package will be offered.
About the Company: Join a dynamic, global, and fast-growing pharmaceutical organisation dedicated to improving the health of others by providing innovative and high-quality medicines that serve overlooked patients.
The company fosters a culture of collaboration, empowerment, and professional growth within a positive work environment.
It prides itself on a patient-centric approach and has a robust product portfolio across various therapeutic areas.
Employees are encouraged to develop and lead global strategies that maximize regulatory success and contribute to meaningful projects impacting millions of lives globally.
This is an exciting opportunity for a highly experienced and strategic leader to take on the role of Global Head of Regulatory Affairs.
The role focuses on navigating complex global regulatory landscapes and facilitating successful market entry for products.
Responsibilities: Oversee regional regulatory leads and staff to ensure global/regional regulatory strategies are written, reviewed, and executed according to plan.
Develop and implement global regulatory strategies for product development, registration, and lifecycle management, with a strong focus on new market entries.
Provide strategic and tactical advice to facilitate the timely and efficient conduct of all regulatory projects.
Establish and maintain a robust global regulatory framework, including policies, procedures, and best practices.
Ensure compliance with all applicable global regulations, guidelines, and standards (e.g., ICH, WHO).
Lead cross-functional initiatives and demonstrate leadership behaviors.
Direct and oversee multiple projects, ensuring regulatory compliance by staff and/or vendors.
Collaborate with other functions and vendors to ensure regulatory submissions and approvals are achieved on schedule.
Partner with access functions to support access applications, including pricing, reimbursement, and HTA.
Develop and lead direct reports, ensuring effective execution of regional regulatory strategies and fostering a culture of excellence and collaboration within the global regulatory affairs team.
Communicate developments that may impact regulatory success to project team colleagues and key stakeholders.
Anticipate risks and develop solutions to identified risks.
Accountable for all global submissions and approvals of projects.
Lead and manage interactions with regulatory authorities and agency meetings, including preparing for major health authority interactions and managing global regulatory interactions, negotiations, and inspections.
Conduct in-depth regulatory intelligence gathering and analysis to identify emerging trends and challenges in key markets.
Provide strategic guidance on regulatory pathways and requirements for diverse international regions (e.g., FDA, EU, Canada, ROW, APAC, LATAM).
Oversee the preparation and submission of global regulatory dossiers (e.g., NDAs, MAAs) to international regulatory agencies.
Lead the development and implementation of global labeling and packaging strategies.
Collaborate with clinical and commercial teams to integrate global regulatory requirements into product development and commercialization plans.
Requirements: MD, PhD, or PharmD in a scientific discipline preferred; Bachelor's degree in a scientific discipline (e.g., chemistry, biology, pharmacy) is required.
15+ years of experience in Regulatory Affairs with proven success in regulatory submissions and approvals, particularly in new markets.
Extensive knowledge of global regulatory requirements and guidelines, including experience with FDA, EU, Canada, ROW, and diverse international regulatory agencies.
Experience with investigational drugs, including late-stage development and marketed products.
Preferred experience in CRO management and prior managerial experience supervising regulatory professionals.
Strong leadership skills with the ability to inspire and motivate teams.
Excellent oral and written communication skills, capable of presenting data to both technical and non-technical audiences.
Excellent interpersonal and communication skills, with the ability to influence and negotiate effectively.
Proficient in MS Office, particularly Excel, PowerPoint, and MS Project.
Fluent in English (written and oral).
Experience working in a geographically dispersed and culturally diverse workforce.
Experience in emerging markets regulatory.
Strong understanding of market access strategies.
Please contact Sarah Kelly, Partner, The Panel, to discuss in confidence.
Seniority level Director
Employment type Full-time
Job function Legal and Science
Industries Pharmaceutical Manufacturing
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