This role will understand and translate regulatory, scientific, operational and business knowledge into effective implementation plans and strategy.\n \nThis is a Boston based, hybrid position requiring 3 days/week onsite.\n \nKey Duties & Responsibilities:\n\n Leads the development of regulatory strategy for multiple and/or complex projects in development (from first-in-human to post marketing application stage) outlined in Global Regulatory Strategy Documents including for regulatory submission documents and Health Authority communications\n Represents GRA on core development teams, project teams, and collaborate with regional leaders and teams to ensure unified regulatory input into clinical programs and commercial strategy\n Addresses complex issues, providing advanced regulatory solutions and guidance to cross-functional teams and align communication to and from cross-functional teams and GRA leadership. A strong leader who demonstrates sensitivity and understanding of cultural considerations, embraces diversity, and continuously develops staff by providing feedback, coaching, guidance and mentoring.\n \nRequired Education & Experience:\n\n Bachelor's degree in Biology, Chemistry, or other related discipline\n* Typically requires 12 years of relevant pharmaceutical or biotech industry experience within regulatory affairs and 5 years of supervisory/management experience, or the equivalent combination of education and experience\n \n#LI-TC1\n \n#LI-Hybrid\n \nPay Range:\n \n$232,000 - $348,000\n \nDisclosure Statement:\n \nThe range provided is based on what we believe is a reasonable estimate for the base salary pay range for this job at the time of posting.