- 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.
- Provides a regulatory strategic focus on non-clinical and clinical aspects of drug development and associated regulations.
- May serve as global regulatory lead (GRL) on the global project team (GPT) for individual project(s) of responsibility
- Collaborates with all Company regions to ensure a global regulatory strategy is created and executed upon for all projects within area of responsibility.
- May be primary FDA contact for projects of responsibility.
location: Cambridge, Massachusetts
job type: Contract
salary: $80.00 - 89.01 per hour
work hours: 9 to 5
- Responsible for leading submission of INDs, CTAs, briefing packages, responses, and other submissions. Works with team to understand and produce documentation for submissions. Major submissions (NDA/BLA/MAA) under oversight of manager.
- Accountable for ensuring all other regulatory submissions within the non-US Americas territories are submitted on schedule by local Company affiliates or development partners (eg, PRA or co-development partners) within project(s) of responsibility by ensuring the regulatory deliverables are provided as outlined in the global regulatory strategy.
- May develop/author or assist Global Regulatory Lead with development of global regulatory strategy.
- For the project(s) of responsibility, collaborates with EU and/or other regional counterparts in the authoring of global regulatory strategies and ensures critical deliverables to territories outside the US 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.
- Identifies regulatory requirements and provides regulatory guidance, and expertise to global development team on the assigned project(s) of responsibility.
- Assists and attends FDA and other agency meetings.
- Present to senior management as requested.
- BSc Degree preferred. BA accepted.
- A minimum of 6 years of pharmaceutical industry experience. This is inclusive of 4 years of regulatory experience or combination of 6 years regulatory and/or related experience.
- Preferred experience in reviewing, authoring, or managing components of regulatory submissions.
- Basic working knowledge of drug development process and regulatory requirements.
- Understands and interprets scientific data as it relates to regulatory requirements and strategy for assigned projects.
- Generally strong in oral and written communications, managing and adhering to timelines, negotiation skills, integrity and adaptability.
- Demonstrates acceptable skills with increasing independence 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.
- Must work well with others and within global teams and acceptable at communicating with senior leadership.
- Able to bring working teams together for common objectives.
skills: Regulatory Affairs Operations, Regulatory Affairs Strategy, Submissions
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.