Senior Regulatory Affairs Strategist

Parexel International; United Kingdom; Hybrid; GBP 70,000 - 90,000; Full time

Job summary

An established international healthcare consulting firm is seeking an experienced Senior Regulatory Affairs Consultant to drive execution and strategy in gaining market approvals across the UK and Ireland. The ideal candidate will possess over 10 years of experience in the pharmaceutical sector, with significant expertise in regulatory affairs and a deep understanding of the UK market landscape. The role demands strong leadership skills, regulatory intelligence, and the ability to manage multiple projects effectively while providing expert guidance to clients.

Qualifications

• 10+ years of experience in the pharmaceutical/biotech industry with substantial experience in Regulatory Affairs.
• Broad background in pharmaceutical business and experience in several areas within regulatory affairs.
• Fluent English, written and spoken.

Responsibilities

• Develop comprehensive international regulatory submission strategies.
• Guide delivery teams in the creation of international dossiers.
• Coach and mentor regulatory teams to ensure objectives are met.

Skills

Leadership in managing regulatory agency negotiations

Strong influencing, negotiation, and relationship management skills

Advanced problem‑solving skills

Education

University degree in a relevant scientific discipline

Tools

Knowledge of CTD format and eCTD submission

Job description

Parexel is seeking an experienced Regulatory Affairs Professional to join our dynamic team as a Senior Regulatory Affairs Consultant. This strategic position requires a proactive and agile regulatory professional able to build strategy, drive execution, and address challenges involved in gaining market approvals across UK and Ireland. You will provide expert guidance to our clients and delivery teams while managing multiple projects in a fast‑paced, results‑oriented environment.

The role can be home or office based in various European locations.

Key Responsibilities:

Strategic Leadership

• Develop comprehensive international regulatory submission strategies for a wide variety of products and projects including CTAs, MAAs and Lifecycle management.

• Provide strategic guidance to clients and delivery teams on requirements and submissions across international regions.

• Support or act as Project Lead, working with local market Regulatory Affairs experts to optimize strategies for specific submissions.

Submission Management

• Guide delivery teams in the creation and maintenance of international dossiers.

• Drive and manage multiple regulatory submissions simultaneously.

• Ensure effective regulatory representation in partnership with appropriate technical experts at health authority meetings.

• Document discussions and agreements with regulatory authorities clearly and comprehensively.

Regulatory Intelligence

• Monitor and stay abreast of key changes in the regulatory environment of international markets.

• Create and perform regulatory intelligence surveys.

• Provide objective assessment of intelligence data.

• Communicate regulatory requirements and propose submission strategies to clients.

Team Leadership

• Coach, mentor and lead regulatory teams to ensure objectives are successfully delivered on time and with quality.

• Identify and mitigate risks with respect to international submissions.

• Guide cross‑functional team discussions and drive regulatory solutions.

Skills and Experience required for the role:

• University degree in a relevant scientific discipline (e.g., Biomedical Sciences, Chemistry, Pharmaceutical Sciences).

• 10+ years of experience in the pharmaceutical/biotech industry, with substantial experience in Regulatory Affairs.

• Broad background in pharmaceutical business and experience in several areas within regulatory affairs (e.g., Global, European, International, Marketing Company or health authority experience).

• Strong knowledge of working on UK and Ireland and with their health authorities.

• Experience with biologics/vaccines/infectious diseases/oncology and rare diseases strongly preferred.

• Leadership in managing regulatory agency negotiations and organizing Scientific Advice Meetings with health authorities.

• Strong knowledge of CTD format and eCTD submission builds, including preparation of Modules 1-5 documents.

• Experience with Clinical Trial Applications and regulations relating to clinical trials.

• Strong influencing, negotiation, and relationship management skills.

• Advanced problem‑solving skills and drive to generate compliant regulatory solutions.

• Fluent English, written and spoken.