Manager Global Regulatory Scientist, Regulatory Affairs in High Wycombe

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.

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

About Innovative Medicine: Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

We are searching for the best talent for a Manager Global Regulatory Scientist, Regulatory Affairs. This hybrid work position will be in Beerse, Belgium, Leiden, Netherlands, High Wycombe/Maidenhead, UK, or Raritan, NJ and Spring House, PA (USA).

Key Responsibilities:

• Draft cover letters and support the preparation of various applications (e.g., IND, CTA, MAA/NDA and eCTD), and procedures for Regulatory Agency submissions.
• For CTA/INDs – Ensure protocols are in alignment with regulatory requirements and provide advice on required documents and submission strategies in preparation for those filings.
• Provide regulatory support throughout the registration process for Marketing Authorization Applications (NDA, MAA or other major HA submissions).
• 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 (other) availability, ensure that all document components are in place on time, identify and track critical path activities.
• Assist with submission and acceptance of Marketing Authorization Applications (NDA, MAA, other).
• 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. Coordinate, contribute to development, and review the content of responses to queries from HAs to ensure high quality and timely responses.
• Liaise with LOCs, track dates of submissions/responses to queries in a timely manner.
• Act as back up contact/representative on specific multi-discipline teams, or with regulatory agencies as needed.
• Provide regulatory input for and appropriate follow-up to inspections, audits, litigation support, and product complaints.
• Support GRL(GRT) by driving high 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 in preparing submissions to Global Health Authorities (HAs).
• Advise the Regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned.
• Partner with regulatory colleagues to understand the competitive landscape, e.g., views of HAs, regulatory precedents, labeling differences, and disease area-specific issues.
• May assist in the development and improvement of regulatory processes.

Qualifications Experience and Skills:

• A Bachelor's degree in scientific or equivalent discipline; advanced scientific degree is preferred, and at least 6 years of health regulated industry experience, or a Master’s degree and a minimum of 5 years of health regulated industry experience or a PhD/PharmD with a minimum of 4 years of health regulated experience.
• At least 4 years of relevant regulatory affairs experience in 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 the areas of clinical research, product development, life cycle submission management and product labeling is required.
• Therapeutic area experience in oncology is beneficial. Experience with combination products (drug and devices) would be an asset.
• Intellectual curiosity and an ability/flexibility in learning new things and working in novel areas with limited regulatory precedence.
• Experience preparing responses to health authorities, managing Health Authorities interactions, and life cycle management of clinical trials and marketing authorizations submissions (e.g., IND/CTAS/NDA/BLA, MAAS other).
• 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 in order to meet business objectives.

10% domestic travel and potential international travel may be required for this position.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to follow local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s).