This is a professional position with responsibilities for regulatory strategy development and execution for high-complexity diagnostics including but not limited to IVDs, Companion Diagnostics and digital pathology in the clinical oncology environment. The Senior RA Specialist/Principal will collaborate cross-functionally and with external business partners on new product development and strategic initiatives to lead the regulatory activities for global commercialization. The incumbent has the ability to innovate, communicate and execute strategic regulatory plans, drive results independently and in a matrix-team environment and is willing to solve complex problems to meet business obligations on-time.
- Serve as Regulatory Affairs representative on new product development teams and external partnership programs.
- Collaborate globally and cross-functionally (e.g., Global Clinical Affairs, Business Development, Quality Assurance, Research & Development, Product/Program Management) to define regulatory strategy and plans for clearance / approval of Leica Biosystems technologies intended for cancer diagnostics in the anatomic pathology, IVD and Companion Diagnostics markets.
- Provide regulatory input to support program scoping including resource requirements and timeline.
- Define and progress evidentiary requirements to meet targeted commercial claims and align with internal partners and stakeholders on study designs.
- Align with external partners and stakeholders on study designs, submissions etc., and participate in relevant meetings.
- Author and maintain regulatory submissions including defining the global regulatory requirements, creating standard work and action plans, optimizing timelines, articulating submission content and format and developing countermeasures as plans evolve.
- Communicate and negotiate with global regulatory agencies to meet business goals and regulatory milestones for product commercialization.
- Keep informed of new and evolving regulatory intelligence and maintain working knowledge of relevant regulations, guidance, requirements and competitive products that affect the business; provide interpretation and education to internal and external stakeholders.
- Share information and experience across LBS and Danaher sites; serves as representative on taskforces, councils or improvement initiatives.
- Integrates DBS principles and practices including leading continuous improvement initiatives, solving complex problems and driving for measurable results.
- Other duties as assigned by management.
- Bachelor’s degree in science or engineering or equivalent experience.
- Must have requisite training in IVD or medical device Regulatory Affairs through on-the-job training, seminars or certification.
- 5+ years progessive experience in support of New Product Development for high complexity products. Experience supporting clinical trials a plus.
- Proven experience with regulatory strategy and submissions for high-complexity diagnostic products in a global market.
- Experience in the IVD, Companion Diagnostics and/or stand-alone software/digital fields preferred.
- Ability to apply practical experience and knowledge of regulatory affairs to the development and commercialization of complex, high-risk products for a global market.
- Skilled at leading teams in a matrix environment to achieve decisions, deliverables and issue resolution in a timely manner.
- Has an understanding of regulatory impacts to the business to analyze global problems and project impacts.
- Models agility in changing strategies and resource allocation in the face of new information.
- Maintains a balance of focus between short term problems and long-term high impact outcomes.
- Sets and communicates high expectations for self and the organization and leads by personal example.
- Demonstrates strong communication skills Ability to explain difficult or sensitive information to an audience with varied knowledge and experience. Works to build consensus.
- Strong writing skills and ability to use appropriate software tools to develop and edit documents, procedures, reports.
- Ability to assess and communicate options and strategic risks/benefits. Is not afraid to take a tough position; acts as a role model for facing problems head-on, making difficult decisions, and taking responsibility for them.
- Ability to manage cross cultural interactions with sensitivity and respect.
Travel % of Travel, include approximate overnight stays per week
- Travel expectations for this role are <30%
- This Position Description is applicable to LBS New Castle UK and Danvers, MA, USA.
- Senior Manager, Global Regulatory Affairs