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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Job Description:

We are searching for the best talent for a Manager, Global Regulatory Affairs, Established Products to be in Warsaw, Poland. This position follows a hybrid working model

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. Learn more at https: //www.jnj.com/innovative-medicine

Key Responsibilities:

The Regulatory Scientist provides support to the Global Regulatory Leader (GRL) for regulatory activities in the assigned portfolio, including assuring that content of regulatory filings support our global regulatory strategy and product strategy position.

Input in development, post-approval and life cycle management

• Participate in global regulatory team meetings as appropriate
• Advise the regulatory team on applicable regulatory requirements, project specific regulatory issues as assigned
• Supporting late life cycle compliance activities, divestment and delisting
• Develop an understanding of the global regulatory environment, competitor intelligence and Established Products portfolio

Liaison with Regulatory Agencies and Local Operating Companies

• Act as back-up for contact with Regulatory Agencies as needed
• Draft cover letters for Regulatory Agency communication
• Assist in the preparation of meetings with Regulatory Agencies
• Liaise with LOCs, and ensure responses to queries are made in timely manner, and that content is consistent with the regulatory strategy.

Input in process development

• Assist in development and improvement of processes related to regulatory submissions;

Clinical Trials

• Review clinical trial plans and protocols and ensure alignment with regulatory requirements;

Health Authority Submissions (e.g. Briefing Books, Scientific advice packages, Marketing Authorization Applications (MAAs), New Drug Applications (NDAs) or equivalent regional or national documents)

• Provide regulatory support throughout registration process and life-cycle management;
• Advise team in required documents and submission strategies (in collaboration with LOCs as appropriate)
• Assist with timely availability of submission documents and ensure that all document components are in place on time e.g. aggregate reports.
• Draft and review some document content (depending on level of regulatory knowledge/expertise)
• Prepare for and participate in cross functional team meetings, as appropriate
• Review of submission documents to ensure compliance with regulatory requirements
• Ensure country-specific submission packages are made available to the LOCs in accordance with agreed plans.

Qualifications

Education:

• University/Bachelor’s degree. Generally 6+ years of overall experience required (5+ years of relevant industry experience preferred). Advance degree or equivalent experience preferred.

Required Technical Proficiencies & Knowledge:

• Knowledge of regulatory requirements related to submissions and of filing registration process.
• Understands dossier component requirements
• Understands submission requirements for lifecycle submissions e.g., protocol amendments, post-approval variations, annual reports, PBRERs/PSURs, renewal applications
• Knowledge of Microsoft programs as well as electronic management systems
• Experience with AI is desired

Regulatory Intelligence

• Understands competitive landscape, e.g., views of HA, regulatory precedence, labelling differences and therapeutic area issues
• Up-to-date knowledge of current and pending approvals in specific, relevant therapeutic areas
• Basic medical/scientific understanding in a clinical area

Regulatory Strategy

• Provide strategic input and technical guidance on regulatory requirements to Global Regulatory Teams
• Ability to interpret and apply local regulations and guidances to the life cycle of a drug product

Health Authority Expertise

• Knowledge of how Health Authorities operate
• General knowledge of HA organizational structures and individual responsibilities in those structures