Omrix Biopharmaceuticals is seeking a Regulatory Affairs Manager.
Primary location Nes Ziona, Israel. Remote work opportunity available in Europe or any reasonable time zone will be considered.
Reports to: Senior RA Manager
Leads, train and develop a team of regulatory affairs professionals according to the requirements and responsibilities of the position, including end-to-end management of life-cycle changes, from regulatory evaluation, through regulatory project management, plan regulatory strategies, design and review of qualification studies, results and scientific justifications, and up to compilation of submission packages and responses to information requests. Schedules and manages periodic submissions to verify compliance with regulatory requirements. Prioritizes tasks according to department workload and capabilities. Provides solutions to a variety of problems of moderate scope and complexity, and status reports to senior management.
DUTIES & RESPONSIBILITIES
•Accountable for all regulatory assignments of the RA team, including:
Performing and documenting regulatory assessments of life-cycle changes according to regulatory requirements of the U.S. FDA, E.U., and rest of world (ROW)
Developing a robust submission strategy according to regulatory requirements in all regions, including required studies and study design
Reviewing of all study reports, scientific justifications and additional submission documentation
Identifying and communicating regulatory risks and mitigations
Compiling submission package
Responding to information requests from global Health Authorities
•Exploring submission pathways and regulatory opportunities, and recommending the most appropriate route according to regulation and business needs and priorities
•Utilizes strategic regulatory thinking along with technical expertise to implement regulatory strategies for post approval changes
•Provides regulatory guidance to project team members regarding health authority requirements for validation and submission
•Performs final review of regulatory assessments, regulatory strategy, study design, risk register and submission package
•Organizes and maintains reporting schedules for new product application, investigational new product applications, post approval projects and periodic submissions
•Manages team resources and prioritizes projects and tasks according to workload, business needs and capabilities
•Coordinates all activities concerned with the strategy, submission, and approval of products to government regulatory agencies between internal and external functions
•Establishes accountability for the preparation of necessary outlines, summaries and status reports for senior management and project stakeholders
•Ensures adherence to standard operating procedures and protocol for the rapid and timely approval of new drugs and regulatory support of marketed drugs and other products
•Interacts with regulatory agency personnel in order to expedite approval of pending application and to resolve regulatory matters
•Develop CMC regulatory strategies which meets global regulatory requirements over the lifecycle of the product
•Coordinate project submission timelines in multiple regions
•Provides regulatory expertise and recommendations to facilitate successful product development globally
•Escalates issues to CMC Regulatory Affairs Senior Management that affect registration, regulatory compliance and continued lifecycle management of the product
•Responsible for talent development of team members
•Identifies and implements improvements to regulatory processes and procedures
•Minimum of a B.A. or B.Sc. or undergraduate degree is required.
•Undergraduate degree in engineering, biological, pharmaceutical, or chemical sciences and/or an advanced degree (i.e. Phar.D. or Ph.D.) is preferred.
•Minimum of 8 years relevant/regulated industry experience is required.
•Minimum of 5 years of relevant progressive experience in CMC / technical regulatory affairs is required
•3+ years of direct People leadership and Management experience is preferred
REQUIRED KNOWLEDGE, SKILLS, ABILITIES, CERTIFICATIONS/LICENSES and AFFILIATIONS.
•Demonstrated ability to communicate regulatory requirements clearly, accurately, and concisely
•Strong knowledge of global health authority laws, regulations, guidance and the regulation submission route available for assigned products
•Experience developing regulatory strategies and an understanding of the product development process
•Expertise in product development and its application in global regulatory strategy
•Solid understanding of biology, chemistry and/or engineering relevant to pharmaceutical and/or biologic industry
•Experience leading/managing regulatory affairs professionals
•High-level verbal and written communication skills, fluent in English
RESPONSIBILITY FOR OTHERS & INTERNAL INTERACTIONS
•Management and leadership of Regulatory Professionals
•Ongoing collaboration with other departments such as QA, QC, R&D, MSO
•Communicating to Regulatory leadership and Business Operating Committees
•Project core team member
LOCATION & TRAVEL REQUIREMENTS
•Primary location Nes Ziona, Israel. Remote work opportunity available in Europe or any reasonable time zone will be considered.
•Occasionally internal meetings in Ramat Gan and international Business Travel (Europe, U.S.) (0%-10%)
•Regular contact with Israeli Ministry of Health, FDA, EMA, Health Canada, Rest of World (ROW) agencies if needed.