Manager Regulatory Scientist

anssen Research & Development, L.L.C., a member of Johnson & Johnson’s Family of Companies, is recruiting for a Manager, Regulatory Scientist, Global Regulatory Affairs. The position will focus on drug products and will be based at one of the following sites: preferred location is Titusville, NJ and other acceptable locations include Raritan, NJ, and Chesterbrook, PA. Other locations, e.g. High Wycombe, UK or Beerse, BE, or flexible remote locations may be considered as well. The candidate must be able to cover the working hours of the US FDA.

Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, hematology, immunology, neuroscience, infectious diseases, cardiovascular, metabolic, mental health, and pain management and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.JanssenRnD.com for more information.

Janssen thrives on a diverse company culture, celebrating the uniqueness of our employees and is committed to inclusion. Janssen is proud to be an equal opportunity employer. Our culture is interconnected by the shared values of Our Credo. It is a culture that celebrates diversity and diverse perspectives, and helps its employees achieve an effective balance between work and home life and supports their efforts to have a positive impact on their communities.

As a Manager, Regulatory Scientist, you will provide regulatory support to the Portfolio Leader for a diverse portfolio of marketed drug products, including anti-infective, CNS, internal medicine, and pulmonary hypertension products, which are supported by the Established Products team. This includes:

• Managing the regulatory activities for products that are currently marketed and ensuring that all regulatory filings support the global regulatory strategy.
• Ensuring compliance and adherence to all post-approval requirements.
• Providing the regulatory strategy for products that may have additional post- approval development activity.
• Representing the regulatory position and providing expertise at cross-functional team meetings as well as providing input to and implementing the global regulatory strategy.

As Regulatory Scientist, you will be expected to:

• Integrate multiple inputs from various functional areas together with regulatory laws and guidance as well as the competitive landscape in order to create a unified regulatory strategy for a product.
• Refine regulatory strategies for Established Products as new data become available.
• Re-assess the global regulatory strategy, as necessary, and provide input to other product-related teams on the implications of the global regulatory strategy.

Specific regulatory functions include:

• Advising teams of required documents and submission strategies.
• Critically reviewing and assembling IND, NDA, CTA, and CTD dossier components for regulatory submissions.
• Managing lifecycle submissions, e.g., IND/NDA annual reports and PSURs/PADERs.
• Responsibility for US FDA correspondence including labeling submissions and safety reporting for several marketed drug products.
• Reviewing dossier content to ensure compliance with regulatory strategy.
• Providing regulatory input and follow-up for inspections or audits on an ad hoc basis.

A significant requirement for this role is the ability to provide support to cross-functional teams on Established Products strategic initiatives e.g., portfolio optimization activities.

Qualifications

Qualifications:

• A Bachelor’s/undergraduate degree is required.
• An advanced degree (e.g., MS, PhD, PharmD) in biological, pharmaceutical, or chemical sciences degree is preferred.
• A minimum of 7 years of experience in the pharmaceutical, medical device, or healthcare industry is required.
• A minimum of 2 years of experience developing or contributing to global regulatory strategies while working in a regulatory affairs or related function (e.g., R&D, quality, regulatory compliance) is required.
• Experience working directly in regulatory affairs is required.
• Excellent oral and written verbal communication skills are required as well as the ability to work successfully within a collaborative, cross-functional, matrix team environment.
• The ability to prioritize effectively for multiple products and projects is required.
• The ability to be based in one of the following locations is preferred: Titusville, NJ, Raritan, NJ, Chesterbrook, PA. Other locations, e.g. Beerse, BE, and High Wycombe, UK, or flexible arrangements for other locations may be considered.
• The ability to cover the working hours of the US FDA is required.
• The ability to travel up to 10% domestic and or international will be required.
• Experience in drug product development is preferred.
• HA regulatory knowledge in the US is required and in any one of the following regions - US /EU / LATAM / AsiaPac is preferred.
• HA regulatory knowledge of US Regulations (21 CFR) is required and of EU Regulations is preferred.
• Knowledge of risk management principles is preferred.
• Knowledge of global drug development and product regulations including current EU Directives relevant to drug development and registration is preferred.
• Experience developing sections/modules for pre- or post-approval submissions for drug products is preferred.
• Experience with drug product regulatory submissions is preferred.
• Experience in participating in Health Authority meetings (especially US FDA; or EMA and national agencies) is preferred.

At Johnson & Johnson, we’re on a mission to change the trajectory of health for humanity. That starts by creating the world’s healthiest workforce. Through cutting-edge programs and policies, we empower the physical, mental, emotional, and financial health of our employees and the ones they love. As such, candidates offered employment must show proof of COVID-19 vaccination or secure an approved accommodation prior to the commencement of employment to support the well-being of our employees, their families and the communities in which we live and work.

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

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, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Ready to be part of something great? Don’t forget to apply. We want YOU!

Primary Location
United States-New Jersey-Titusville-1125 Trenton Harbourton Road
Other Locations
Europe/Middle East/Africa-Belgium-Antwerp-Beerse, North America-United States-New Jersey, Europe/Middle East/Africa-United Kingdom-England-High Wycombe
Organization
Janssen Research & Development, LLC (6084)
Job Function
Regulatory Affairs
Requisition ID
2105991284W