Job title: Regulatory Strategy & Continuous Improvement - Platform Lead

• Location: Morristown, NJ

About the job

As Regulatory Strategy & Continuous Improvement - Platform Lead within our R&D team, you will lead multiple interconnected initiatives involving diverse stakeholders across the organization, orchestrating multiple concurrent programs with varying timelines, priorities, and resource requirements across global regulatory landscapes. You will establish and maintain global responsibilities across GRA CMC & GRA Device departments, build and manage cross-functional governance structures to facilitate decision-making, identify synergies between parallel projects to leverage shared resources, and establish metrics and KPIs to track progress and drive continuous improvement. Additionally, you will facilitate resolution of cross-project dependencies and conflicts, develop communication strategies to maintain visibility of project interdependencies, and synchronize change management processes across interconnected systems and procedures.

Your responsibilities will include driving transversal process-related activities and projects across the department, contributing to activities and ways of working harmonization/standardization, validating and updating worldwide CMC post-approval regulatory requirements databases, and representing GRA CMC and/or GRA Device departments in transversal working groups and for Quality & Performance topics. You will establish and promote best practices and sharing experiences, manage and facilitate information sharing across departments to ensure connectivity and alignment on critical CMC & Device topics, and contribute to inspection-readiness as applicable.

Main responsibilities

• Lead multiple interconnected and non-interconnected initiatives involving diverse stakeholders across the organization.
• Orchestrate multiple concurrent programs with varying timelines, priorities, and resource requirements across global regulatory landscapes.
• Establish and maintain global responsibilities across GRA CMC & GRA Device departments, ensuring alignment between project objectives and broader organizational strategy.
• Build and manage cross-functional governance structures to facilitate decision-making across interconnected projects
• Identify synergies between parallel projects to leverage shared resources, eliminate redundancies, and maximize efficiency.
• Establish metrics and KPIs to track progress across the project portfolio and drive continuous improvement.
• Faciliate resolution of cross-project dependencies and conflicts through effective negotiation and prioritization.
• Develop communication strategies to maintain visibility of project interdependencies and ensure alignment across stakeholder groups.
• Synchronize change management processes across interconnected systems and procedures.
• Cover a global responsibility across GRA CMC & GRA Device departments on activities within his/her scope
• Drive/Manage transversal process related activities and or projects across the department and deliver documents (e.g. quality documents, Functional Best practice guides, slide kits...) helping the end-users to apply defined processes and ways of working.
• Contribute to activities / WoW harmonization/standardization by taking the following action(s)
• Optimize & improve efficiency of change control process, and of process for management of CMC post-approval commitments
• Contribute to inspection-readiness as applicable
• Validate, update & consolidate worldwide CMC post-approval regulatory requirements database for CMC Post-approval changes & RenewalsRepresent GRA CMC and/or GRA Device departments in transversal working groups dedicated to tools/systems optimization, e.g., IDMP
• Represent GRA CMC and/or GRA Devices departments for Quality & Performance topics (e.g., quality documents creation/updates, KPIs...).
• Establish and promote best practices and sharing experiences, e.g., manage/facilitate sharing of information across GRA CMC and/or GRA Device departments to ensure connectivity and/or to align on practices and critical CMC & Device topics.

About you

Education

• Bachelor's degree in a scientific discipline, or
• Advanced degree (Masters, PhD) in a science or health field is desirable

Experience

• Minimum 4 years of CMC and/or Devices regulatory experience. Additional 1-5 years of country/region-specific regulatory expertise is desirable.
• Experience in project management is required.
• Experience working for a Regulatory Authority, Quality Department, manufacturing site, project management/direction is preferred but not essential.

Soft skills

• Experience working in a matrix environment and excellent people skills are required.
• Previous experience working in a fast-paced environment on multiple project lines is highly desirable.
• Ability to work transversally and to assume leadership of transversal topics/projects
• Strong organization skills
• Should demonstrate flexibility, proactivity, initiative, assertiveness & be able to communicate efficiently with various stakeholders internally and externally.
• Potential to be able to mentor and train staff is desirable but not essential.

Technical skills

• Knowledge of worldwide Health Authorities regulations, of key Health Authorities thinking (guidance/requirements/feedback), and regulatory trends.
• Strong background in project management and understanding of drug development, manufacture, or testing.
• Familiarity with combination (drug / device) products is preferred.
• Proficient in MS Word, Excel, PowerPoint
• Demonstrated ability to work successfully on global project teams.

Languages

• Fluent in English both spoken and written

Why Choose Us

• Bring the miracles of science to life alongside a supportive, futurefocused team.
• Discover endless opportunities to grow your talent and drive your career, whether it's through a promotion or lateral move, at home or internationally.
• Enjoy a thoughtful, well-crafted rewards package that recognizes your contribution and amplifies your impact.
• Take good care of yourself and your family, with a wide range of health and wellbeing benefits including high-quality healthcare, prevention and wellness programs and at least 14 weeks' gender-neutral parental leave.
• Be part of a pioneering biopharma company that engages patients early in drug development and uses their insights to design studies that reflect real-world needs.
• Work at the forefront of drug discovery, harnessing cutting-edge AI, data, and digital platforms to push the boundaries of science.
• Help improve the lives of millions of people globally by making drug development quicker and more effective.

The salary range for this position is:
$148,500.00 - $214,500.00

All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs. Additional benefits information can be found through the LINK.