Manager Global Regulatory Affairs

Description:

Ethicon, Inc., is recruiting for a Global Regulatory Affairs CMC Manager for the Ethicon Biosurgery Franchise. 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. Other J&J locations throughout the U.S. and Europe will be considered. Remote work options may be considered on a case-by-case basis and if approved by the Company.

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 Global Regulatory Affairs CMC Manager for Ethicon’s Biosurgery business unit will be responsible for leading a team of Regulatory professionals and partnering with R&D, Supply Chain, and other cross-functional team members and leaders to obtain and maintain Ethicon’s biologic, drug, and combination product portfolio globally through project team support, audit support, excellence in submission execution, global health authority interactions, and growing and developing talent.

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:

• Lead, inspire, motivate, and manage a team of Regulatory CMC professionals to obtain and maintain market access for Chemistry, Manufacturing, and Controls (CMC) related changes to Ethicon Biosurgery biologic, drug, and combination products. (Currently this position is responsible for managing 5 team members, which includes both permanent and contract staff.
• Mentor, coach, train, and develop technical and professional skills of the Regulatory CMC team.
• Maintain up-to-date understanding of global biologic, drug, and combination product regulations and guidance documents and advise Regulatory Affairs team and internal stakeholders on the interpretation and application of health authority expectations.
• Oversee assessment and communication of global CMC changes, strategies, risks, and requirements to internal business partners and leadership teams.
• Clearly and timely communicate compliance issues to Regulatory Management and business leadership 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 regional Regulatory leaders on regulatory strategy and submissions to successfully obtain and maintain marketing approvals for all other markets.
• 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.
• Lead Health Authority meetings for key markets and interact with Health Authorities regarding product regulatory filings.
• Evaluate the impact of current and emerging standards and regulations, assess the most effective and efficient strategies for obtaining or maintaining product registrations globally, and communicate changes and impact to cross-functional business partners.
• Demonstrate a deep scientific and technical understanding of products under the scope of responsibility to provide strategic guidance and support for product development and 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.
• Collaborate with Quality partners regarding product non-conformance and quality issues by contributing to internal investigation and risk management reviews.
• Manage, oversee, and balance resource allocation across critical projects.
• Influence and collaborate to bring about process and technical improvements within the organization.
• Manage 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.
  
  

• Bachelor’s/undergraduate 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 8 years of regulated healthcare industry experience, or an advanced degree and a minimum of 5 years of regulated healthcare industry experience is required.
• Previous experience with biologic or drug Regulatory Affairs is required.
• Previous experience with medical device and/or combination product regulatory affairs is preferred.
• Demonstrated track record representing your function on cross-functional or leadership teams is required.
• Previous experience developing and executing regulatory strategies that align with business deliverables is preferred.
• Previous experience leading, mentoring, coaching, or developing people or teams is required.
• Previous experience interacting with Health Authorities (for example: FDA, EMA, or other Health Authority meetings, negotiations, or audits) is required.
• 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.)