Director EMEA Regulatory Leader - Neuroscience

Johnson and Johnson; High Wycombe; On-site; GBP 80,000 - 120,000; Full time

Job summary

A leading company in healthcare innovation is seeking a Director EMEA Regulatory Leader to oversee the development and registration of neuroscience products. This role involves strategic regulatory leadership, team management, and collaboration with regulatory agencies across Europe, the Middle East, and Africa. Candidates should possess a Master's degree in life sciences and extensive regulatory experience, with strong skills in communication and project management.

Qualifications

• Over 10 years of broad EU regulatory experience in drug development and commercialization.
• Experience across multiple therapeutic areas and countries.

Responsibilities

• Lead the development and registration of neuroscience products.
• Develop and drive regional regulatory strategies.
• Establish strong relationships with regulators.

Skills

Influencing skills

Conflict resolution skills

People management

Project management

Communication skills

Strategic thinking

Innovative mindset

Education

Masters' degree in life sciences

Job description

At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.

Job Function: Regulatory Affairs Group

Job Sub Function: Regulatory Affairs

Job Category: People Leader

All Job Posting Locations: High Wycombe, Buckinghamshire, United Kingdom

Job Description

About Johnson & Johnson

We are committed to healthcare innovation to build a healthier world. Our expertise in Innovative Medicine and MedTech allows us to develop solutions that prevent, treat, and cure complex diseases with smarter, less invasive treatments that are personalized.

Position Overview

Janssen Global Regulatory Affairs Europe, the Middle East, and Africa (EMEA) is seeking a Director EMEA Regulatory Leader in the Neuroscience Therapeutic Area (TA). This role involves leading the development and registration of neuroscience products within the region, serving as a regulatory leader or managing a team to develop and implement strategies for efficient development and timely commercialization of pharmaceutical products compliant with regional regulations.

The role can be based in multiple locations within the EU at a Janssen office, offering the opportunity to work on diverse neuroscience disease assets and contribute to healthcare innovation.

Key Responsibilities

• Develop and drive regional regulatory strategies supporting global development plans.
• Understand regional regulatory environments, gather competitor intelligence, and contribute to policy activities.
• Represent EMEA in global regulatory teams and regional IBVTs.
• Drive target labels and submissions considering regional regulatory needs.

Organization and Talent Development

• Lead, develop, and coach regulatory professionals and junior leaders.
• Support goals aligned with the EMEA commercial organization.
• Manage resources effectively within your focus area.

Liaison with Regulatory Agencies

• Establish strong relationships with regulators, lead interactions on study design, submissions, labeling, and post-approval commitments, and act as primary contact with EMA.
• Address issues raised by agencies promptly and incorporate feedback into development plans.
• Coordinate with local regulatory teams for agency meetings and negotiations on labeling.

Documentation and Process Development

• Contribute to briefing documents, pediatric plans, orphan designations, and response documents to optimize labels.
• Assist in developing regulatory submission processes.
• Provide regulatory input throughout the product lifecycle.

Clinical Trial Applications (CTA)

• Ensure protocols align with regional strategies for registration and reimbursement.
• Guide teams on CTA requirements and manage submission timelines.

Marketing Authorization Application (MAA)

• Lead regulatory efforts during registration and post-approval phases.
• Manage submissions and define submission strategies.
• Track critical activities and ensure timely availability of MAAs.

Qualifications

Education and Experience

• Masters' degree in life sciences or equivalent experience.
• Over 10 years of broad EU regulatory experience in drug development and commercialization across multiple therapeutic areas and countries.

Skills

• Strong influencing and conflict resolution skills.
• People management, project management, excellent communication skills, and experience in matrix organizations.
• Strategic thinking and innovative mindset.
• Ability to stay updated on regional regulatory developments and assess their impact.

Knowledge

• Fluent in English.
• Deep knowledge of EMEA regulatory environment, guidelines, and practices.
• Therapeutic area knowledge is preferred.

Note: This role is available across multiple countries and may be posted under different requisition numbers to meet local requirements. Focus your application on the specific country(s) of your preference.