Job Description Actively represent Regulatory on interdisciplinary teams (e.g. CMC Teams, Program Teams) and with business partners such as CDMOs, consultants, etc. Collaborate with cross-functional teams to generate and refine the product development strategy. Lead quality portions of global clinical trial applications including the preparation of initial INDs/CTAs/GMOs and amendments, responses to agency questions, and maintenance activities. Coordinate and drive regulatory CMC submissions, including necessary cross-functional teams and timelines, relevant to assigned projects or programs. Actively contribute to the preparation and execution of global agency interactions. Responsibilities + Represent Regulatory on interdisciplinary teams and with business partners. + Collaborate with cross-functional teams to develop and refine product development strategies. + Lead quality aspects of global clinical trial applications, including preparation of initial INDs/CTAs/GMOs and amendments. + Respond to agency questions and manage maintenance activities. + Coordinate and drive regulatory CMC submissions, ensuring collaboration with cross-functional teams and adherence to timelines. + Contribute to the preparation and execution of global agency interactions. Essential Skills + Bachelor’s degree in a scientific discipline; Masters, PharmD, or PhD preferred. + Minimum of 4 years of experience in regulatory affairs in the pharmaceutical/biotech industry, including IND activity, global CTAs, DSURs, and Agency briefing documents in US and ex-US. + Strong knowledge of US and EU regulations and guidances pertaining to investigational drug studies. + Ability to effectively organize and prioritize tasks to meet deadlines. + Ability to work independently and within project teams to achieve group goals. + Excellent verbal and written communication skills. + Excellent organizational and program management skills. + Strong collaboration skills with multi-disciplinary teams. + Creative problem-solving and strategizing abilities. Pay and Benefits The pay range for this position is $156000.00 - $177000.00 Medical dental vision, PTO/holiday, 20% bonus. they also have stock options included. They also offer a competitive salary Workplace Type This is a hybrid position in Cambridge,MA. Application Deadline This position will be accepting applications until Dec 20, 2024. About Actalent Actalent is a global leader in engineering and sciences services and talent solutions. We help visionary companies advance their engineering and science initiatives through access to specialized experts who drive scale, innovation and speed to market. With a network of almost 30,000 consultants and more than 4,500 clients across the U.S., Canada, Asia and Europe, Actalent serves many of the Fortune 500. Diversity, Equity & Inclusion At Actalent, diversity and inclusion are a bridge towards the equity and success of our people. DE&I are embedded into our culture through: + Hiring diverse talent + Maintaining an inclusive environment through persistent self-reflection + Building a culture of care, engagement, and recognition with clear outcomes + Ensuring growth opportunities for our people The company is an equal opportunity employer and will consider all applications without regard to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law. If you would like to request a reasonable accommodation, such as the modification or adjustment of the job application process or interviewing process due to a disability, please email actalentaccommodation@actalentservices.com (%20actalentaccommodation@actalentservices.com) for other accommodation options.