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Randstad, Cambridge, MA
permanent $ 153,000 - $ 186,000 per year
Company: Takeda Pharmaceuticals, Cambridge MA Type: Full-time, Permanent ACCOUNTABILITIES: - Oversees as well as executes all regulatory activities of multiple projects including one highly complex project in development and/or supports regulatory activities for assigned marketed product(s) of responsibility. - Manages direct reports to support scope of project work. - Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations. - Serves as regulatory lead on the global clinical development team (GCDT) for individual project(s) of responsibility or delegates to staff with oversight. - Collaborates with all Takeda regions to ensure a global regulatory strategy is created and executed upon for all projects within projects of responsibility. - Primary regulatory authority contact for projects of responsibility or can delegate to staff with oversight. - Working with global colleagues (if applicable), leads the regulatory working team and represents team at global clinical development meetings ensures global regulatory strategy written and executed according to plan - Accountable for all submissions and approvals of project(s) of responsibility or oversees direct reports responsible. - Responsible for independently achieving all submissions levels, including major submissions (NDA/BLA/MAA); may oversee staff in achieveing major submissions. - For the project(s) of responsibility, collaborates with global colleagues and/or other regional counterparts in the authoring of global regulatory strategies and ensures critical deliverables to territories outside of region to ensure regional execution of the strategy as agreed within the global regulatory strategy . - Executes day-to-day activities for projects or delegates to staff with oversight. - Direct point of contact with health authorities, leads and manages regulatory authority interactions/meetings. Working hours: Standard - BSc Degree preferred. BA accepted. - Advanced Degree preferred - Considerable pharmaceutical industry experience. This is inclusive of extensive regulatory experience or combination of ample regulatory and/or related experience. - Solid working knowledge of drug development process and regulatory requirements, knowledge of FDA, EU, Canada, ROW, and post-marketing a plus. - Preferred experience in managing major regulatory filing(s); and significant contributor to regulatory and/or development strategies - Understands and interprets complex scientific issues across multiple projects as it relates to regulatory requirements and strategy. - Generally strong in most and acceptable in all basic skill sets such as oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability. - Generally strong in working well with others and within global teams; and acceptable at communicating with senior leadership - Generally strong and independent skills in the area of regulatory strategy such as understanding broad concepts within regulatory affairs and implications across the organization and globally; proactively identifies regulatory issues; offers creative solutions and strategies, including risk mitigation strategies. Randstad is a world leader in matching great people with great companies. Our experienced agents will listen carefully to your employment needs and then work diligently to match your skills and qualifications to the right job and company. Whether you're looking for temporary, temporary-to-permanent or permanent opportunities, no one works harder for you than Randstad. EEO Employer: Race, Religion, Color, National Origin, Citizenship, Sex, Age, Disability, Ancestry, Veteran Status, Genetic Information, Service in the Uniformed Services or any other classification protected by law. [show more]
- July 13, 2015
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