Senior Regulatory Affairs Specialist

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

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

Professional

All Job Posting Locations:

Berlin, Germany, Leipzig, Germany, Muenchen, Germany, Nes-Ziona, Center District, Israel, Prague, Czechia

Job Description

About Surgery

Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of surgery? Ready to join a team that’s reimagining how we heal? Our Surgery team will give you the chance to deliver surgical technologies and solutions to surgeons and healthcare professionals around the world. Your contributions will help effectively treat some of the world’s most prevalent conditions such as obesity, cardiovascular disease and cancer. Patients are waiting.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

We are searching for the best talent for a Senior Regulatory Affairs Specialist position for our Ness Ziona site in Israel.

Purpose: The position will focus on biologic products, drug products, and drug-device combination products and may be based at any J&J site. Preferred locations are the J&J sites located at Ness Ziona, Israel or Raritan, New Jersey, United States. Other J&J locations (e.g. U.S., Canada, Europe) and remote work options will be considered on a case-by-case basis and if approved by the Company.

The Senior Regulatory Affairs Specialist for our Surgery business unit will be the Regulatory lead on significant manufacturing change projects, including manufacturing line scale-up, material and component replacements, and manufacturing site transfers, for the Ethicon Biosurgery drug and biologic portfolio. The Regulatory lead will partner with R&D, Technical Operations, Supply Chain, and other cross-functional team members to obtain and maintain Ethicon’s biologic, drug, and combination product portfolio globally through project team support, audit support, excellence in submission execution, and global health authority interactions.

You Will Be Responsible For

The products supported by this position are regulated worldwide as biologics, drugs, or high-risk medical device (combination products) which are intended to address a range of surgical challenges related to bleeding and sealing. Primary responsibilities will include:

• Represent Regulatory Affairs on cross-functional project teams by providing robust global regulatory impact assessments and reviewing and providing feedback on project documentation.
• Research, draft, circulate for cross-functional review and approval, and submit global regulatory affairs submissions. This role will be responsible for submissions directly to the United States Food and Drug Administration, European Medicines Agency, and Israel Ministry of Health. Other markets will require interaction with J&J Affiliate Regulatory Affairs to coordinate submission activities.
• Clear, accurate, and timely communication with project team members, stakeholders, and management about regulatory requirements, submission deliverables, timelines, and risks.
• Clearly and timely communicate compliance issues to Regulatory Management that could affect registration or regulatory compliance.
• Active role on project teams to maintain close alignment between supply chain strategy and regulatory compliance and timelines.
• Oversee the strategy development, health authority negotiations, submission content, and post market commitments for U.S., EU, and Israel CMC-related regulatory filings.
• Partner with external manufacturers and strategic external partners to communicate CMC changes, evaluate impact of changes, and ensure joint regulatory responsibilities are fulfilled and compliant.
• Interact with Health Authorities in key markets regarding product regulatory filings.
• Demonstrate a deep scientific and technical understanding of products under the scope of responsibility to provide strategic guidance and support for life-cycle management of products.
• Integrate changing, complex, and/or ambiguous information for effective decision-making and clearly communicate challenges and solutions to stakeholders to achieve strategic and/or project goals.
• Assist with front-room and back-room regulatory activities associated with internal and external audits.
• Ensure that company policies, procedures and practices are compliant with appropriate regulatory requirements.
  
  

• A Bachelor's degree and at least 6 years of regulated healthcare industry experience, or an advanced degree and a minimum of 3 years of regulated healthcare industry experience is required.
• Previous experience with biologic or drug Regulatory Affairs is preferred.
• Previous experience with medical device and/or combination product regulatory affairs is preferred.
• Previous experience representing your function on cross-functional project teams is required.
• Previous experience developing and executing regulatory strategies that align with business deliverables is preferred.
• Previous experience interacting with Health Authorities (for example: FDA, EMA, or other Health Authority meetings, negotiations, or audits) is preferred.
• High-level verbal and written communication skills is required.
• Up to 10% travel may be required. (Primary locations for travel may include Israel, Spain, Denmark, and New Jersey, USA).