Associate Principal Scientist, Global Regulatory Lead

Organon • Jersey City, NJ

1d • $125,400 - $213,100 • Remote

About The Position

The Associate Principal Scientist, Global Regulatory Lead, reporting to the Executive Director, Fertility Lead, will be responsible for the development and implementation of world-wide regulatory strategies, including CMC elements, for the medical devices and combination products (MDCP) portfolio. This role involves independently managing projects, serving as the single point of contact for global regulatory strategy, and leading Global Regulatory Teams. The position requires interaction with worldwide regulatory agencies and coordination of regulatory activities for investigational and marketed devices/combination products, including those that are complex or involve external business partners. The role also entails conducting regulatory reviews, performing risk assessments, and communicating strategic decisions to stakeholders. Expertise will be provided to Product Development Teams and other regulatory functions. The Associate Principal Scientist will also monitor and communicate new legislations, guidelines, and standards affecting the company's products, support regulatory activities for medical devices, and review/approve local registration study protocols. Representation of the company with external organizations, including leading meetings with regulatory agencies like the FDA and EMA, and preparing teams for scientific advice and advisory committee meetings, is a key responsibility. The role involves coordinating interactions with foreign agencies, reviewing and approving Worldwide Marketing Applications, Clinical Study Reports, and protocols, and providing expert advice on regulatory issues throughout the product lifecycle. Participation in internal committees, regulatory due diligence, and driving organizational success through project involvement and problem-solving are also expected. Additionally, the role includes providing education and training to company professionals to ensure compliance.

Requirements

• Ph.D., Pharm. D., or M.D. with 3 years relevant drug development experience required preferably with 3 years in Regulatory OR M.S. or B.S. with 5 years relevant device or drug development experience, a majority of which should be in Regulatory
• Fluency in English (written and spoken)
• Develops and manages world-wide regulatory strategies of assets that tend to be at a medium activity and complexity level, as well as post-approval products with limited clinical development
• Regulatory product and compliance management (coordinates the preparation, submission and maintenance of asset applications)
• Has good verbal and written communications skills (manages communications with health agencies)
• Has knowledge of regulatory regulations and guidance from key health agencies.
• Has an intermediate level understanding of his/her therapeutic area.
• Has superior interpersonal skills to navigate difficult situations and able to work seamlessly with all levels of personnel from R&D, commercial and manufacturing organizations.
• Has proven track record to be able to think critically, strategically, independently and problem solve.
• Has a high level of motivation, drive, and demonstration of Organon 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; experienced at building and leading high performing teams; exemplifies corporate and ethical integrity; drives success consistent with company values and priorities.
• Regulatory experience required with preference for therapeutic area experience in Medical Devices and Combination Products

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; functioning as the single, accountable, global point of contact for global regulatory strategy development including CMC related considerations
• Executes 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 per established business processes and systems
• Lead the Global Regulatory Teams, which coordinates 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 one or more of investigational and/or marketed devices/combination products.
• Cover programs that may be complex with more than one indication, formulation, or have an external business partner.
• Coordinate the preparation, submission, and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions.
• Conduct Regulatory review and final approval of all submissions and associated documentation; perform risk assessments and communicate strategic decisions taken to obtain stakeholder alignment.
• Provide expertise as the Global Regulatory Lead to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and outside.
• Communicate new legislations, guidelines and standards which may affect company’s product to other Teams, to ensure that any broader impact to the organization is fully understood and assessed.
• Support regulatory activities of medical devices including standalone and combination with medicinal products.
• Review and provide the final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.
• Represent our company with external organizations through direct communication with the FDA, EMA, or other EU regulatory agencies, including telephone calls and e-mail; chair meetings between company and FDA or EMA; prepare our company's teams for meetings with FDA or EMA at any phase of drug development. Lead cross-functional efforts to prepare and lead discussion at scientific advice and advisory committee meetings.
• Coordinate interactions with foreign agencies working closely with regional colleagues to support their interactions and provide strategic direction across multiple regions simultaneously.
• Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, Clinical Study Reports, protocols, Confidential Investigator Brochures before release from our company to external agencies and investigators.
• Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.
• Represent Global Regulatory Affairs within our company's internal committees to provide regulatory advice and approval according to the committee charters.
• Participate in regulatory due diligence activities for licensing candidate review as needed
• Participate in projects outside of current responsibilities as needed to drive the organization forward to success.
• Contribute to determining solutions outside of current responsibilities as needed and manage day-to-day operational issues outside of current responsibilities, as needed.
• Provide education, training, and advise company professionals to ensure compliance with internal and external processes, procedures, policies, and regulatory requirements.

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

What This Job Offers

• Job Type: Full-time
• Career Level: Principal
• Education Level: Ph.D. or professional degree