Director, Regulatory Affairs Reading

Meeveem Limited; Reading; On-site; GBP 80,000 - 100,000; Full time

Benefits offered by this job

Competitive salary

Health and wellbeing programmes

Retirement and pension plans

Life assurance and disability coverage

Employee assistance programmes

Learning and development opportunities

Job summary

Meeveem Limited is seeking a Director of Regulatory Affairs to guide compliance with regulatory standards and provide strategic direction. The role demands collaboration with internal and external teams to shape robust regulatory strategies, oversee submission management, and navigate European pathways.

Candidates should have 10-12 years of industry experience, including leadership and communication skills, along with a Bachelor’s degree in a relevant field. Competitive salary and benefits are offered.

Qualifications

• 10-12 years of experience in regulatory affairs, with a proven track record.
• Experience in high-performing teams and delivering results.
• Expertise in European regulatory procedures (CP/DCP).

Responsibilities

• Collaborate on regulatory strategies for product development.
• Manage submission of regulatory documents for marketing authorization.
• Lead regulatory agency interactions and provide insights.

Skills

Regulatory strategy development

Excellent communication

Leadership skills

Stakeholder management

Education

Bachelor’s degree in scientific discipline or healthcare-related field

Advanced degree preferred

Job description

Director Regulatory Affairs

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.

As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.

As a Director, Regulatory Affairs at ICON, you will ensure compliance with regulatory requirements and provide strategic direction to ICON's customers both in pharma and small biotechs.

What You Will Do

• Driving Strategic Development: Collaborating with internal and external teams to define and develop robust regulatory strategies, utilizing Target Product Profiles (TPPs) and Clinical Development Plans (CDPs) to achieve broader development goals.
• Leading Submissions & Lifecycle Management: Directing the development, hands‑on authoring, and submission management of regulatory documents. This includes overseeing initial European Marketing Authorisation Applications (MAAs - CP, MRP, or DCP) as well as post‑licensing lifecycle management.
• Navigating European Pathways: Managing complex pre‑marketing designation submissions in Europe, with specific expertise in Orphan Drug Designations, Paediatric Investigation Plans (PIPs), and PRIME.
• Leading Agency Interactions: Leading regulatory agency interactions from the front— including Scientific Advice meetings—while coaching and training customer or internal SMEs to achieve optimal meeting objectives.
• Providing Regulatory Intelligence & Insights: Overseeing the interpretation of relevant legislation and guidelines to drive informed decision‑making and establish strong partnerships with regulatory agencies.

Your Profile

You will bring significant regulatory affairs experience developed across 10-12 years of industry and/or consulting roles, with a track record of working in high‑performing teams and delivering results.

Required qualifications and experience

• Education: At least a Bachelor’s degree in a relevant scientific discipline or healthcare‑related field; advanced degree preferred.
• Experience: Extensive experience in regulatory affairs within the clinical research or pharmaceutical industry, with a proven history of managing European regulatory procedures (CP/DCP) and post‑authorization activities. Candidates with advanced therapy or international market experience are particularly welcome although this is not essential.
• Strategic & Technical Ability: Deep expertise in developing regulatory strategies (TPPs, CDPs), combined with self‑sufficiency in technical document writing and submission management.
• Leadership Skill: Strong leadership skills and a proven ability to manage cross‑functional teams and complex projects in a collaborative environment.
• Communication: Excellent interpersonal, stakeholder management, and agency negotiation skills, with the ability to influence and drive change in a complex organization.
• Travel: Willingness to travel as required (approximately 25%).

Rewards & Benefits

• Competitive base salary and performance related incentives
• Health and wellbeing programmes including medical, dental, and vision coverage where applicable
• Retirement and pension plans
• Life assurance and disability coverage
• Employee assistance programmes and wellbeing resources
• Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported. If you require reasonable accommodations during the recruitment process, please let us know or submit a request.

Employment with ICON is contingent upon having the legal right to work in the country where the role is based.