Director, Regulatory Strategist

This is a fully remote position, open to applicants in United Kingdom, +1 more country.

📋 Description

• Offer strategic regulatory insights utilizing innovative regulatory methods for designated projects/products.

• Formulate and execute global regulatory strategies for intricate products/projects.

• Oversee the preparation and submission of communications and applications to regulatory bodies.

• Organize, lead, or engage in discussions with regulatory authorities.

• Ensure that quality standards are upheld for submissions and interactions with Health Authorities.

• Direct and/or facilitate dialogues with Health Authorities in collaboration with regulatory local/regional partners.

• Lead global Regulatory Teams for designated projects/products.

• Develop global/regional regulatory strategies and implementation frameworks.

• Collaborate with cross-functional project teams as the Regulatory Point of Contact.

• Work alongside clinical, safety, and medical teams on product development and maintenance initiatives.

• Contribute to the development and updates of the Target Product Label and CCDS.

• Drive regulatory contributions and submission packages, which include meeting requests, dossier sections, and responses to inquiries.

• Monitor regulatory plans, communicate progress to senior management, and address risks.

• Cultivate working relationships with Health Authority contacts.

• Assist in regulatory due diligence for business development prospects.

• Evaluate evolving global and regional regulations and their implications for products/projects.

• Ensure compliance with regulatory requirements and commitments for Marketing Authorizations.

• Implement regulatory standards, systems, processes, and enhancements in productivity.

⛳️ Requirements

• A B.S. in a Scientific discipline is required.

• Relevant experience in Global and/or Regional regulatory affairs.

• Comprehensive knowledge of the regulatory landscape and the ability to leverage this for effective regulatory strategy formulation and execution.

• Demonstrated experience in managing global and/or regional regulatory and registration activities within drug development and/or post-marketing lifecycle management.

• Capability to handle complex regulatory challenges.

• Experience in managing multiple products across various stages of the product lifecycle is highly desirable.

• Proven track record of delivering results within time, cost, and quality benchmarks.

• Established ability to collaborate successfully with Regulatory, Commercial, Safety, Medical, and other cross-functional partners as well as senior stakeholders.

• Proven history of negotiating with major Health Authorities, including taking the lead in such interactions.

• Demonstrated strategic thinking and capacity to translate strategies into actionable plans.

• Proven ability to perform effectively within a highly matrixed organization.

• Excellent written and verbal communication skills.

• Strong history showcasing extensive depth and breadth of regulatory strategy, allowing for a leadership role with minimal oversight.

• An advanced Scientific Degree (Ph.D., Pharm.D., M.D., M.Sc.) and/or business qualification (DMS, MBA) may be advantageous but is not mandatory.

🏝️ Benefits

• Competitive salaries.

• Comprehensive benefits package.

• An inclusive work environment.

• Commitment to equal opportunity employment.