Sr. Scientist, Regulatory Liaison

Job description

Job Description Team Overview: The GRACS RDDH team assists in bringing new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance across regulatory agencies. We are an international network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world through a highly regulated industry. Position Overview: Under the direction and guidance of the Executive Director, Regulatory Digital Health the incumbent will assist in driving the overarching strategy for the Digital Health Medical Device Modality in partnership with the Global Regulatory Leads (GRLs), Chemistry, Manufacturing and Control (CMC) scientists, Pharmacovigilance (PV), Global Labeling (GL), and various other functions. The incumbent will partner with these organizations and others to ensure the development and clinical aspects needed to support, plan, and/or execute regulatory strategies and filings. The incumbent will help drive the development of new processes and establishment of internal guidance/policy that enables timely and accurate advice to Global Regulatory Teams and Product Development Teams to ensure adherence to evolving global regulations. Primary duties/assignments: Support communication and assessment of the emerging regulatory landscape and drive cross-functional implementation of existing and new requirements across affected Global Regulatory Affairs and Clinical Safety (GRACS) functional areas for devices and digital health solutions. Provide support to assigned Global Regulatory Teams (GRTs) with a broad GRACS perspective on device and digital health aspects impacting product development and share leading practices for teams to incorporate into their regulatory strategies. Contribute to the strategic vision and planning of digital health initiatives that establish operational processes and systems to fully incorporate device and digital health into the company way of working across the broad product portfolio. Build and maintain new processes that facilitate resources and support key activities and initiatives. Ensure close collaboration with cross-functional and cross-divisional teams (Research, Manufacturing, Commercial, IT) to align and incorporate regulatory requirements into strategies for devices and digital health solutions to ensure successful product registrations. Conduct assigned policy reviews and support organizational risk management initiatives, including providing audit and assessment support. Support the development of best-practice guidance for regulatory deliverables for digital health to support therapeutically aligned development teams. Schedule as needed and actively facilitate discussions and interactions with cross-functional and cross-divisional teams and/or external partners. Independently manage assigned work or lower-to-moderate complexity initiatives, which includes to track milestones, risks, issues, and dependencies, and escalate effectively with recommended solutions. Conduct independent research, fact-finding, and guidance review to identify gaps, synthesize insights, and support regulatory or operational decisions. Communicate clearly in written and verbal formats and present effectively in team and cross-functional settings with minimal support. Demonstrate ownership, accountability, initiative, and sound judgment while working effectively in ambiguous or changing environments. Build productive working relationships across functions and influence without formal authority to move work forward. Support team capability by sharing knowledge, lessons learned, and best practices with colleagues as needed. Education: Minimum: Bachelor’s Degree in Regulatory Affairs, Quality Assurance, Clinical Affairs, Pharmacovigilance, Biology, Engineering, Chemistry, or related science field Preferred: Advanced degree and/or RAPS RAC, ASQ Quality, or Scrum certifications Required Experience and Skills: Knowledge of global regulatory requirements and the emerging landscape for drugs and devices for both new and existing products. Broad awareness of digital health technologies and their application to drug development and marketed biopharmaceutical products. Strong independent execution of assigned work and ability to deliver high-quality outputs with limited supervision. Demonstrated analytical thinking, problem solving, and ability to interpret information and translate it into actionable recommendations. Strong cross-functional collaboration skills and ability to influence without formal authority. Excellent communication and presentation skills. Ability to work effectively in ambiguity, manage competing priorities, and adapt to changing business needs. Demonstrated ownership, accountability, and initiative. Curiosity and willingness to learn, take on stretch assignments, and expand knowledge of policies, processes, and tools. At least two (2) years of relevant experience, including medical device/biological/pharmaceutical research; compliance, manufacturing, testing, quality, regulatory affairs; or related fields. Preferred fields of study include engineering, regulatory affairs, quality, policy, or related sciences. Required Skills: Competency Management, Drug Development, Influencing Skills, Influencing Without Authority, Managing Ambiguity, Negotiation, Presentation Delivery, Process Improvements, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Filings, Regulatory Management, Regulatory Processes, Regulatory Reporting, Regulatory Strategy Development, Regulatory Submissions, Stakeholder Management, Strategic Thinking, Taking Initiative, Team Training, Working Independently Preferred Skills: Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. Learn more about your rights, including under California, Colorado and other US State Acts The salary range for this role is $117,000.00 - $184,200.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other ins