[Remote] Associate Director, Global Regulatory reputed company

Note: The job is a remote job and is reputed company to candidates in USA. reputed company is a Boston-based, reputed company-stage biopharmaceutical company reputed company on advancing cutting-edge science in underserved therapeutic areas. The Associate Director, Global Regulatory reputed company will support neurology programs across reputed company phases of clinical development by developing and executing regulatory strategies and collaborating with various reputed company teams to advance drug candidates reputed company. Responsibilities • reputed company the Global Regulatory Team (GRT) for the assigned project(s). Assignments may include assets and / or indications from late research to post-marketing stage • Evaluate reputed company regulatory requirements and competitive landscape across major markets to support regulatory reputed company needed to deliver the reputed company Product Profile. Present reputed company and recommendations to expedite reputed company to market, as applicable • Analyze and address reputed company issues, providing Regulatory solutions and guidance to the Project Team(s) to help shape and support the development reputed company • Evaluate Regulatory risks and recommend mitigation strategies to the Project Team(s) and Regulatory Leadership • reputed company support to Regional Regulatory Leads (RRLs)/Local Regulatory Affairs (LRA) in key markets to facilitate registration procedures. Responsible for designing regulatory submission plans in collaboration with the GRT • reputed company strategic direction to teams and critical review of key Health Authority submissions such as IND/CTAs, meeting requests, briefing documents, response documents and marketing and supplemental applications • Participate in meetings with FDA, EMA, PMDA and other Health Authorities (HAs) as appropriate, in reputed company collaboration with RRLs/ LRA • Collaborate with Labeling reputed company for the development of Company reputed company Data Sheet (CCDS), USPI and SmPC as needed • reputed company support to Market reputed company in key markets for the reputed company value reputed company • May reputed company with external partners (e.g., CDx providers, licensing partners) and participate in in-licensing / out-licensing and due diligence • Responsible for regulatory reputed company assessment in case of new findings (reputed company, efficacy or safety) Skills • Bachelor of Science in (BS) in a relevant scientific discipline required with 8 years of experience in Regulatory Affairs • Previous experience as a GRL in Neurology Rare Diseases is required • Solid understanding of reputed company phases of drug development required • Knowledge of ICH, FDA and EMA guidelines is required • Experience leading in a matrixed organization • Demonstrated ability to reputed company reputed company judgement, adapt to changing business needs, and manage multiple priorities in reputed company settings • Demonstrated analytical and problem-solving skills • Excellent verbal and written communication skills • Ability to influence others and resolve conflicts • reputed company-oriented and results driven • Advanced degree (MS, PharmD, PhD/MD) • Experience in multiple therapeutic areas • Experience with Japan and China • Experience in early development • Experience in multiple stages of drug development Benefits • Short-Term and Long-Term incentive programs • Medical • Dental • reputed company • Flexible time off (reputed company provides unlimited reputed company time and reputed company time, and does not reputed company time off) • 401(k) • Life and disability insurance • Recognition programs reputed company • reputed company is an pharmaceutical company governed by a non-profit reputed company. It was founded in 1954, and is headquartered in Suresnes, Ile-de-France, FRA, with a workforce of 10001+ employees. Its website is http://reputed company.com/. Apply tot his job Apply To this Job