Overview:
TekWissen is a global workforce management provider throughout the UK, Europe and many other countries in the world. The below client is an American multinational pharmaceutical and biotechnology corporation.
Job Title: Regional Regulatory Strategist – Oncology
Location: Walton Oaks. Surrey, UK
Duration: 9 Months
WorkType : Hybrid
Job Description:
* The Regional Regulatory Strategist is responsible for leading regulatory strategy and execution within a designated region (US, EU, or Emerging Markets).
* This role provides strategic regulatory expertise within global project teams, ensuring timely submissions, approvals, and commercially competitive product labeling to support the successful development and lifecycle management of oncology products.
* You will represent regional regulatory perspectives on global regulatory plans and serve as a key partner in interactions with regional Health Authorities.
Key Responsibilities
* Lead and implement regional regulatory strategies to align with global project objectives and commercial goals.
* Ensure regional contributions to global strategies, including core labels and implementation plans.
* Manage regulatory submissions such as CTAs/INDs, MAAs/NDAs, variations, and renewals within agreed timelines and quality standards.
* Develop and maintain working relationships with regional regulatory agencies to support successful approvals.
* Monitor regulatory milestones, assess risks, and ensure resolution of issues that could impact development or commercialization.
* Advocate for aligned regional positions on regulatory matters and communicate effectively across project teams.
* Ensure compliance with regulatory standards and contribute to shaping the external regulatory environment where appropriate.
Qualifications & Skills
* Scientific degree required; advanced degree is advantageous.
* Proven experience with regional regulatory processes, clinical trial oversight, and product registration.
* Experience representing products before major health authorities (FDA, EMA, or relevant regional agency).
* Strong knowledge of drug development regulations and industry guidelines.
* Track record in developing and delivering regulatory strategies across lifecycle stages.
* Excellent communication, presentation, and negotiation skills to engage internal and external stakeholders.
Stakeholder Collaboration
* Collaborates closely with global regulatory leads, project teams, and regional commercial and medical colleagues.
* Works directly or through affiliates with regulatory agencies, experts, and key opinion leaders in the assigned region.
TekWissen® Group is an equal opportunity employer supporting workforce diversity.