Associate Director, Regulatory Affairs Strategy

Kinsley Power Systems; Cambridge (MA); Hybrid; USD 149,000 - 224,000; Full time

Job summary

A leading biopharmaceutical company is seeking an Associate Director, Regulatory Affairs Strategy, to develop regulatory strategies supporting clinical plans. This role involves overseeing submissions, interacting with authorities, and guiding a regulatory team. Ideal candidates will possess robust industry experience and a strong knowledge of drug regulations, fostering an inclusive work environment that values diverse perspectives.

Benefits

Premium benefits package

Professional growth prioritization

Competitive and equitable compensation

Psychological safety in the workplace

Commitment to diversity and community

Qualifications

• Minimum 8 years in pharmaceutical industry and 6 years in Regulatory affairs strategy.
• Ability to manage multiple projects and resolve regulatory issues.
• Strong interpersonal skills and team collaboration.

Responsibilities

• Develop and oversee global regulatory strategies.
• Plan and lead regulatory submissions for trials and marketing.
• Manage and mentor individuals within the regulatory team.

Skills

Knowledge of drug development

FDA, EMA and ICH guidelines

Organizational skills

Communication skills

Problem solving

Team collaboration

Education

Bachelor’s degree in life sciences

Advanced degree preferred

Job description

Associate Director, Regulatory Affairs Strategy

Who we are:

Agios is a biopharmaceutical company that is fueled by connections. We thrive in a supportive, fun, and flexible environment full of people empowered to bring their whole selves to work. We care deeply about our work, each other, and the patients who count on us. Our teams cultivate strong bonds with patient communities, healthcare professionals, partners and colleagues, which helps us discover, develop and deliver therapies for rare diseases – and make a bigger difference in their lives. In the U.S., Agios markets a first-in-class pyruvate kinase (PK) activator for the treatment of hemolytic anemia in adults with PK deficiency. Building on the company’s leadership in the field of cellular metabolism, Agios is advancing a robust clinical pipeline of investigational medicines with active and planned programs in alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency and MDS-associated anemia.

The impact you will make:

Agios Pharmaceuticals is searching for a dynamic Associate Director, Regulatory Affairs Strategy to join our growing Regulatory team. We want someone who cares about this important work, and who’s driven to connect to our mission of helping these patient communities. The Associate Director will be responsible for developing regulatory strategies to support clinical development plans, working cross-functionally across the organization. This individual will be responsible for preparing and overseeing development of compliant, high quality, nonclinical and clinical global regulatory submissions to support early development, registration and life cycle management.

What you will do:

• 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

What you bring:

• 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

Concerned that you don’t check off every box in the requirements listed above? Please apply anyway! At Agios, we value each other’s differences and recognize that teams thrive when everyone brings their unique experiences to the table. We are dedicated to building an inclusive, diverse, equitable, and accessible environment where all employees can bring their whole selves to work. If you’re excited about this role but your previous experience doesn’t align perfectly with the job description, we still encourage you to apply. You may be just the right candidate for this role or another opening!

Work Location:

Location Agnostic: Work location for this role is based on employee's individual preference. This role has the ability to be either remote in the US or hybrid in our Cambridge Headquarters. Hybrid schedules vary but are generally less than 3 days per week onsite and hybrid employees are expected to live within commutable distance to our Cambridge Headquarters. Remote employees work entirely from home except for attending Company sponsored events/ meetings. For employees who choose to work remotely, travel may be required for certain company events commensurate to the above job description.

What we will give you:

• Deliberate Development. Your professional growth as one of our top priorities.
• 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. For more detail on the benefits we offer at Agios, visit the Inside Agios section of our website.
• Competitive and equitable performance-based compensation. This includes base salary and both short- and long-term incentives that are connected to our business strategy and vary based on individual and company performance.
• The current base salary range for this position is expected to be between $149,069 and $223,604 annualized; final salary will be determined based on various factors including, but not limited to, years of relevant experience, job knowledge, skills and proficiency, degree/education, and internal comparators.
• 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.

Interested in learning more about what makes our culture unique? Visit the Inside Agios section of our website.