Senior Regulatory Affairs Specialist

Description:

Ethicon, Inc., is recruiting a Senior Regulatory Affairs Program Lead, CMC for the Ethicon Biosurgery Franchise. The position will focus on biologic products, drug products, and drug-device combination products.

Ethicon, part of the Johnson & Johnson Medical Devices Companies, has made significant contributions to surgery for more than 60 years from creating the first sutures, to revolutionizing surgery with minimally invasive procedures. Our continuing dedication to Shape the Future of Surgery is built on our commitment to help address the world's most pressing health care issues and improve and save more lives. Through Ethicon's surgical technologies and solutions including sutures, staplers, energy devices, trocars and hemostats and our commitment to treat serious medical conditions like obesity and cancer worldwide, we deliver innovation to make a life-changing impact. For more information, visit www.ethicon.com.

The Senior Regulatory Affairs Program Lead, CMC for Ethicon’s Biosurgery 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.

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:

Key Responsibilities:

• 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.
  
  

• Relevant Bachelor’s degree is required.
• Advanced degree is a plus.
• Degree in a technical related discipline (e.g. biological, pharmaceutical, or chemical sciences) is preferred.
  
  

• 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.
  
  

• Job location – Israel only (Hybrid)
• High-level verbal and written communication skills is required.
• Up to 10% travel may be required. (Primary locations for travel may include Spain, Denmark, and New Jersey, USA).