Associate Principal Scientist, Global Regulatory Lead

About the role

Associate Principal Scientist, Global Regulatory Lead responsible for the development and implementation of worldwide regulatory strategies, including CMC elements, for the medical devices and combination products (MDCP) portfolio.

Responsibilities

• Develop regulatory strategy for medical devices and combination products (MDCPs) to optimize labeling claims and obtain shortest time to approval by regulatory agencies, including but not limited to US-FDA, EU/Notified Bodies, and other agencies worldwide.
• Independently manage projects as the single, accountable, global point of contact for global regulatory strategy development, including CMC-related considerations.
• Execute regulatory strategies by leading the development, authoring, and review of MDCP CMC submission components to support post-approval supplements, annual reports, registration renewals, and responses to health authority questions.
• Lead the Global Regulatory Teams, coordinating cross-functional regulatory support for development programs and marketed products.
• Independently interact with worldwide regulatory agencies and/or subsidiaries regarding global regulatory strategy/registration requirements for investigational and/or marketed devices/combination products.
• Coordinate the preparation, submission, and follow-up contact with regulatory agencies for all applications and submissions.
• Conduct regulatory review and final approval of all submissions and associated documentation; perform risk assessments and communicate strategic decisions to obtain stakeholder alignment.
• Provide expertise as the Global Regulatory Lead to Product Development Teams and serve as the regulatory single point-of-contact for products within Global Regulatory Affairs and externally.
• Communicate new legislations, guidelines, and standards that may affect the company’s products to ensure broader organizational impact is understood and assessed.
• Support regulatory activities for medical devices, including standalone and combination products with medicinal products.
• Review and provide final approval of local registration study protocols to obtain marketing authorization in secondary markets.
• Represent the company with external organizations through direct communication with the FDA, EMA, or other EU regulatory agencies; chair meetings and prepare teams for interactions at any phase of drug development.
• Lead cross-functional efforts to prepare for and lead discussions at scientific advice and advisory committee meetings.
• Coordinate interactions with foreign agencies, working closely with regional colleagues to provide strategic direction across multiple regions.
• Review and provide final approval for Worldwide Marketing Applications, Clinical Study Reports, protocols, and Confidential Investigator Brochures before release to external agencies and investigators.
• Provide expert regulatory advice to Product Development Teams and subsidiaries on issues arising with developmental compounds or marketed products throughout their lifecycle.
• Represent Global Regulatory Affairs within internal committees to provide regulatory advice and approval according to committee charters.
• Participate in regulatory due diligence activities for licensing candidate review as needed.
• Contribute to projects outside of current responsibilities to drive organizational success, including managing day-to-day operational issues.
• Provide education, training, and advice to company professionals to ensure compliance with internal and external processes, procedures, policies, and regulatory requirements.

Requirements

• Ph.D., Pharm. D., or M.D. with 3 years of relevant drug development experience, preferably with 3 years in Regulatory, or M.S. or B.S. with 5 years of relevant device or drug development experience, a majority of which should be in Regulatory.
• Fluency in English (written and spoken).
• Experience developing and managing worldwide regulatory strategies for assets at a medium activity and complexity level, as well as post-approval products with limited clinical development.
• Regulatory product and compliance management experience, including coordinating the preparation, submission, and maintenance of asset applications.
• Strong verbal and written communication skills, with experience managing communications with health agencies.
• Knowledge of regulatory regulations and guidance from key health agencies.
• Intermediate-level understanding of the therapeutic area.
• Superior interpersonal skills to navigate difficult situations and collaborate seamlessly with all levels of personnel across R&D, commercial, and manufacturing organizations.
• Proven ability to think critically, strategically, and independently, with strong problem-solving skills.
• High level of motivation, drive, and demonstration of leadership values.
• Demonstrated scientific knowledge, writing ability, effective communication, and thorough familiarity with worldwide regulatory agencies, especially US-FDA and EU regulations.
• Outstanding interpersonal, communication, and negotiation skills.
• Demonstrated leadership attributes, including experience building and leading high-performing teams.
• Regulatory experience required, with preference for therapeutic area experience in Medical Devices and Combination Products.

About the company

Organon delivers ingenious health solutions that enable people to live their best lives. A $6.5 billion global healthcare company focused on making a world of difference for women, their families, and the communities they care for. Organon has an important portfolio and is growing it by investing in unmet needs in Women’s Health, expanding access to leading biosimilars, and touching lives with a diverse and trusted portfolio of health solutions. The company’s vision is clear: A better and healthier every day for every woman.

Pay

Annualized salary range for this position in the U.S. is $125,400.00 - $213,100.00.

Benefits

• Retirement savings plan.
• Paid vacation and holiday time.
• Paid caregiver/parental and medical leave.
• Health benefits including medical, prescription drug, dental, and vision coverage in accordance with the terms and conditions of the applicable plans.

Schedule

• Employee Status: Regular.
• Relocation: No relocation assistance provided.
• VISA Sponsorship: Not specified.
• Travel Requirements: Employees must be able to satisfy all applicable travel and credentialing requirements, including associated vaccination prerequisites.
• Shift: Flexible work arrangements.
• Valid Driving License: Required.