לוח אפשרויות קריירה - הדרך החכמה להייטק

a global biotech company is looking for global regulatory affairs manager
o 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.
o Mentor, train and develop technical and professional skills of the Regulatory CMC team.
o 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.
o Oversee assessment and communication of global CMC changes, strategies, risks, and requirements to internal business partners and leadership teams.
o Clearly and timely communicate compliance issues to Regulatory Management and business leadership that could affect registration or regulatory compliance.
o Active role on project teams to maintain close alignment between supply chain strategy and regulatory compliance and timelines.
o Oversee the strategy development, health authority negotiations, submission content, and post market commitments for U.S., EU, and Israel CMC-related regulatory filings.
o Partner with regional Regulatory leaders on regulatory strategy and submissions to successfully obtain and maintain marketing approvals for all other markets.
o Partner with external manufacturers and strategic external partners to communicate CMC changes, evaluate impact of changes, and ensure joint regulatory responsibilities are fulfilled
o Lead Health Authority meetings for key markets and interact with Health Authorities regarding product regulatory filings.
o 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.
o 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.
o 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.
o Collaborate with Quality partners regarding product non-conformance and quality issues by contributing to internal investigation and risk management reviews.
o Manage, oversee, and balance resource allocation across critical projects.
o Influence and collaborate to bring about process and technical improvements within the organization.
o Manage front-room and back-room regulatory activities associated with internal and external audits.
o Ensure that company policies, procedures and practices are compliant with appropriate regulatory requirements.

דרישות:

o Bachelor's/undergraduate degree is required.
o At least 6 years of regulated healthcare industry experience
o Experience with biologic or drug Regulatory Affairs is required.
o Experience with medical device and/or combination product regulatory affairs is preferred.
o Previous experience interacting with Health Authorities (for example: FDA, EMA, or other Health Authority meetings, negotiations, or audits) is required.