Regulatory Affairs Manager
- 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 director reports to support scope of project work.
- Provides tactical and strategic advice to teams to achieve timely and efficient development and maintenance of programs, while ensuring compliance with applicable regulatory requirements.
- Serves as regulatory lead on the global development team (GDT) for individual project(s) of responsibility or delegates to staff with oversight.
- Collaborates with all regions to ensure a global regulatory strategy is created and executed upon for all projects within projects of responsibility.
- Is a leader both in the department and within R&D, contributing to cross-functional initiatives and influencing the field as possible.
location: Cambridge, Massachusetts
job type: Contract
salary: $107.96 - 127.01 per hour
work hours: 9 to 5
- The Associate Director will be responsible for increasingly complex or multiple projects. Leads the Global Regulatory Team (GRT) and applicable sub-working groups, such as the Labor Working Group, and represents GRT at project team meetings. Defines strategies and provides tactical guidance to teams and collaborates cross-functionally to ensure global regulatory strategy is updated and executed, ensuring global regulatory compliance and/or oversees direct reports or junior staff responsible.
- Proactively anticipates risks and responsible for developing solutions to identified risks and discussing with team and management; understands probabilities of technical success for the solutions.
- Accountable for all US FDA 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 achieving major submissions.
- Accountable for ensuring all other regulatory submissions within the non-US Americas territories are submitted on schedule by local affiliates within project(s) of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy.
- Oversee multiple projects and manager individual projects.
- For the project(s) of responsibility, collaborates with EU co-lean and/or other regional counterparts in the authoring of global regulatory strategies and ensures critical deliverables to territories outside the Americas to ensure regional execution of the strategy as agreed within the global regulatory strategy
- Develop/author and execute global regulatory strategies for more complex strategies. May oversee execution.
- Executes day-to-day activities for projects or delegates to staff with oversight.
- Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
- Direct point of contact with health authorities, leads and manages FDA/health authority interactions/meetings.
- Lead and manage Agency meetings.
- Lead regulatory reviewer in due diligence for licensing opportunities.
- Identifies and proposes solutions to the management of for any resource gaps for areas of project responsibility.
- Provides oversight to ensure regulatory compliance of marketed products.
- Present to senior management as requested.
- Usually includes supervision of one or more direct reports.
- BSc Degree preferred. BA accepted.
- Advanced Degree preferred
- A minimum of 8 years of pharmaceutical industry experience. This is inclusive of 6 years of regulatory experience or combination of 8 years 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. Knowledge of Biologics is a plus.
- 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. Worker will need to be flexible due to the day to day needs of the projects and team.
- 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.
- Generally strong leader who is effective manager and is able to bring working teams together for common objectives, people management experience preferred.
skills: NDA, FDA
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.