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. Learn more at https: //www.jnj.com

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About Johnson & Johnson

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 Description

Janssen Global Regulatory Affairs Europe, the Middle East, and Africa (EMEA) is recruiting for a Director EMEA Regulatory Leader in the Neuroscience Therapeutic Area (TA) to lead the development and registration of neuroscience products in the EMEA region. The successful applicant will serve as a regulatory leader and/or manage a team to develop and implement regulatory strategies to achieve efficient development and timely commercialization of innovative pharmaceutical products in compliance with applicable regulations and regional needs.

The position can be based in multiple locations in the EU with a Janssen office. The job provides an opportunity to work on assets in different neuroscience diseases/indications, contributing to healthcare one patient at a time!

Key Responsibilities:

Develop regulatory strategies for innovative new medicines

• Develop and drive implementation of regional regulatory strategies in support of the global development plan.
• Develop a deep understanding of the regional regulatory environment, competitor intelligence and therapeutic area; Contribute to regulatory policy related activities where applicable.
• Represent EMEA region in global regulatory team as well as EMEA regional Integrated Brand Value Team (IBVT).
• Drive the target label and submission based on an understanding of the regional regulatory and cross-functional needs.

Organization and talent development:

• Lead, develop and coach regulatory professionals and/or more junior regulatory leaders.
• Support goals and objectives aligned with the EMEA commercial organization.
• Conduct resource management planning for your area of focus, where applicable.

Liaison with Regulatory Agencies

• Establish strong working relationships with regulators to lead effective interactions on clinical study design, submissions content, labeling, and post-approval commitments and act as primary contact with European Medicines Agency (EMA).
• Ensure that issues raised by Regulatory Agencies are promptly and adequately addressed and ensure implementation of Regulatory Agency comments into the development plan.
• Ensure appropriate involvement and liaise with local operating company (LOC) regulatory affairs personnel to facilitate local Regulatory Agency meetings.
• Prepare team, manage, conduct and facilitate contacts/meetings with Regulatory Agencies.
• Negotiate labeling with Regulatory Agencies, going through each of the back-up strategies.

Input in document and process development

• Play a key role in crafting comprehensive briefing documents, pediatric investigation plans, orphan drug designations, and summary and response documents to bolster the regional strategy and achieve the most optimal label outcome.
• Contribute to the development of processes related to regulatory submissions.
• Provide regulatory input to critical submission documents throughout the product lifecycle across responsible disease area.

Clinical Trial Applications (CTA)

• Ensure protocols in alignment with regional registration strategies to support registration, reimbursement, and differentiated labeling.
• Guide cross-functional team on EMEA CTA requirements.
• Ensure CTA submissions are complete and available according to agreed timelines.

Marketing Authorization Application (MAA)

• Provide regulatory leadership throughout registration process and post-approval.
• Manage submissions, define submission plans, and provide input to team on required documents and submission strategies in preparation of MAAs.
• Ensure timely MAA availability, track critical path activities.
• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans.

Qualifications

Education and experience

• Masters' degree in life sciences or equivalent experience
• Extensive and broad EU regulatory experience (10+ years) in drug development and commercialization (for example, experience in multiple therapeutic areas, multiple phases of drug development, multiple countries)

Skills

• Influencing and conflict resolution skills
• People management skills, complex project management skills and excellent oral & written communication skills, as well as experience working in a matrix organization are required.
• Demonstration of long-term strategic insight and innovative thinking.
• Ability to keep abreast of regulatory developments in the region and assess business impact.

Knowledge

• Excellent knowledge of English
• In-depth knowledge of the regulatory environment, guidelines and practice of EMEA regions is required.
• Knowledge of the applicable therapeutic area preferred

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, perform crucial job functions, and receive other benefits and privileges of employment.

Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, or national origin, and will not be discriminated against on the basis of disability.