Associate Principal Scientist, Global Regulatory Lead

Job Description

The Position

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.

Primary 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, 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.

Requirements For Education, Experience & Skills

• 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 strat