Manager Global Regulatory Scientist, Regulatory Affairs in High Wycombe

Key Responsibilities

• Draft cover letters and support the preparation of various applications such as IND, CTA, MAA/NDA and e CTD, and procedures for Regulatory Agency submissions.
• For CTA/INDs – ensure protocols align with regulatory requirements and advise on required documents and submission strategies.
• For Marketing Authorization Applications (NDA, MAA or other major HA submissions): provide regulatory support throughout the registration process.
• Advise team on required documents and submission strategies in preparation of NDA, MAA (and other global filings) as assigned, in collaboration with LOCs as appropriate.
• Assist with timely NDA, MAA (and other) availability, ensuring all document components are in place on time, tracking critical path activities.
• Assist with submission and acceptance of Marketing Authorization Applications (NDA, MAA, and others).
• Ensure country‑specific submission packages are made available to the LOCs in accordance with agreed plans.
• Assist in the preparation of meetings with Regulatory Agencies and review the content of responses to queries from HAs to ensure high quality and timely replies.
• Liaise with LOCs, track submission and query response dates in a timely manner.
• Act as backup contact/representative on specific multidisciplinary teams or with regulatory agencies as needed, including meeting organization and leadership.
• Provide regulatory input for and appropriate follow‑up to inspections, audits, litigation support, and product complaints.
• Support GRL (GRT) by driving high‑level project management planning of global submissions or Health Authority interactions and additional major regulatory milestones.
• Participate in global regulatory team meetings as appropriate.
• Assist in strategy development by researching regulatory and medical information for global Health Authority submissions.
• Advise the Regulatory team on applicable regulatory requirements and project‑specific regulatory issues.
• Partner with regulatory colleagues to understand the competitive landscape, including views of HAs, regulatory precedents, labeling differences, and disease‑area‑specific issues.
• Assist in the development and improvement of regulatory processes.

Qualifications, Experience and Skills

• A Bachelor’s degree in a scientific or equivalent discipline; an advanced scientific degree is preferred, with at least 6 years of health‑regulated industry experience, or a Master’s degree with a minimum of 5 years of experience, or a Ph D/Pharm D with a minimum of 4 years of regulated experience.
• At least 4 years of relevant regulatory affairs experience in the pharmaceutical/biotech industry is required.
• Knowledge of multiple global health authorities’ regulations and processes would be ideal.
• Solid understanding of FDA and ICH regulatory requirements and guidelines specific to clinical research, product development, lifecycle submission management, and product labeling.
• Therapeutic area experience in oncology is beneficial; experience with combination products (drug and device) would be an asset.
• Intellectual curiosity and a willingness to learn new things and work in novel areas with limited regulatory precedence.
• Experience preparing responses to health authorities, managing Health Authority interactions, and lifecycle management of clinical trials and marketing authorization submissions (e. g., IND/CTAS/NDA/BLA, MAAS, etc.).
• Experience in strategic planning, technical data summary, and cross‑functional management is required.
• Leadership Capabilities
• Strong organizational and time‑management skills.
• Strong collaboration skills, including effective communication and conflict‑resolution skills.
• Strong leadership capabilities and ability to work successfully in a matrixed environment.
• Effective critical thinking, including problem solving and goal setting.
• Demonstrated ability to think strategically and contingency‑plan to meet business objectives.
• 10% domestic travel and potential international travel may be required for this position.

Locations

High Wycombe, Buckinghamshire, United Kingdom (and additional locations in Belgium, Netherlands, Netherlands, US)

This posting is available across multiple countries and may have different requisition numbers.

Applicants should focus on the specific country or countries that align with their preferred location.

Required Skills

Analytical Reasoning, Business Writing, Coaching, Compliance Risk, Fact‑Based Decision Making, Industry Analysis, Legal Support, Process Improvements, Product Licensing, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Risk Assessments, Strategic Thinking, Technical Credibility.

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