Associate Director, Regulatory Strategy
Agios
- Cambridge, MA
- Permanent
- Full-time
- Develop and execute, or oversee global regulatory strategy for long-term planning, including the potential to accommodate expedited development needs.
- Work within cross-functional teams to provide global regulatory expertise in support of the development, review, and approval of strategies and documents intended to enable clinical trials and marketing authorizations.
- Plan, lead, develop, and review regulatory submissions, such as clinical trial and marketing applications, life-cycle management submissions.
- Plan and lead health authority interactions and develop or contribute to the development and review of associated documents.
- Manage and mentor individuals within the regulatory affairs team, providing guidance and support as needed.
- Engage with Regulatory Authorities on project related matters, as needed.
- Ensure adherence to current regulations associated with regulatory activities.
- Bachelor’s degree in life-sciences or related scientific discipline; advanced degree preferred.
- Associate Director: Must have minimum of 8 years pharmaceutical industry with 6 years in Regulatory affairs strategy.
- Strong demonstration of knowledge of drug development, FDA, EMA and ICH guidelines and regulations
- Excellent organizational and communication skills, both written and verbal
- Ability to work independently as well as part of a team environment.
- Positive attitude, energetic and proactive
- Proven ability to manage multiple projects, identify and resolve regulatory issues.
- Strong interpersonal skills and the ability to effectively work with others.
- Deliberate Development. Your professional growth as one of our top priorities.
- Flexibility. We’re all about individual needs. We embrace different perspectives, work styles, health and wellness approaches, care of families and productivity. When you’re at your best, we’re at our best.
- Premium benefits package. We invest in the health, wellbeing and security of our people with a premium benefits package that is well-rounded and flexible to help meet the varied personal and professional needs of every member of our team.
- Competitive performance-based compensation. This includes both short- and long-term incentives that are connected to our business strategy.
- Psychological safety. We support an environment of fearlessness. We want you to share your ideas, speak candidly and take data-informed risks to help push the boundaries.
- Commitment to diversity. We strive to foster a welcoming workplace where everyone can thrive. We’re continuously looking to improve the inclusivity of our workforce.
- Commitment to community. We’re an active participant in the communities that surround us – the communities where we live, and the community of people and their loved ones in need of better treatment options for conditions that are often overlooked.