Senior Manager/Associate Director, Regulatory Affairs Strategy and Labeling - Remote

Society for Conservation Biology; Town of Texas (WI); Remote; USD 100,000 - 150,000; Full time

Job summary

A leading biopharmaceutical company seeks a Senior Manager/Associate Director of Regulatory Affairs Strategy and Labeling. This remote role involves developing regulatory strategies, managing submissions, and ensuring compliance. Candidates should have a strong background in regulatory affairs, excellent communication skills, and the ability to work independently and collaboratively.

Benefits

Flexible work arrangements

Comprehensive benefits package

Competitive salary and performance-based incentives

Deliberate professional development

Supportive and inclusive workplace culture

Community involvement and support initiatives

Qualifications

• Minimum of 4 years (Senior Manager) or 6 years (Associate Director) in regulatory strategy and labeling.
• Strong knowledge of drug development, FDA, EMA, and ICH guidelines.
• Ability to manage multiple projects and resolve regulatory issues.

Responsibilities

• Develop and execute regulatory strategies for clinical development.
• Collaborate with teams on regulatory strategy and labeling.
• Lead responses to health authority inquiries.

Skills

Regulatory Affairs strategy

Regulatory Product Information Labeling

Communication

Organizational skills

Interpersonal skills

Education

Bachelor's degree in life sciences or related field

Advanced degree preferred

Job description

Senior Manager/Associate Director, Regulatory Affairs Strategy and Labeling - Remote

Employer: Agios Pharmaceuticals | Location: Trammell's, Texas, US | Salary: Competitive | Closing date: May 20, 2025

Sector: Consultancy/Private Sector | Field: Conservation science | Discipline: Biology | Job Level: Senior level | Salary Type: Salary | Employment Type: Full time

About Us

Agios is a biopharmaceutical company driven by connections. We foster a supportive, fun, and flexible environment where employees are encouraged to bring their whole selves to work. Our commitment is to our work, each other, and the patients we serve. We build strong bonds with patient communities, healthcare professionals, partners, and colleagues to discover, develop, and deliver therapies for genetically defined diseases. Currently, in the U.S., we market a first-in-class pyruvate kinase (PK) activator for treating hemolytic anemia in adults with PK deficiency. Building on our leadership in cellular metabolism, we are advancing a robust pipeline of investigational medicines for conditions like alpha- and beta-thalassemia, sickle cell disease, pediatric PK deficiency, and MDS-associated anemia.

The Impact You Will Make

We are seeking a Senior Manager/Associate Director of Regulatory Affairs Strategy and Labeling to join our Regulatory team. This role involves working cross-functionally to develop and execute regulatory strategies supporting clinical development plans and managing global regulatory submissions, including labeling documents such as CCDS, regional product information, and patient leaflets.

What You Will Do

• Contribute to and execute global regulatory strategies for long-term clinical development, including expedited development needs.
• Collaborate with cross-functional teams to provide expertise in regulatory strategy and labeling for clinical trials, marketing authorizations, and labeling approvals.
• Lead responses to health authority inquiries regarding clinical trials, marketing applications, and labeling.
• Plan, develop, and review regulatory submissions, including clinical trial applications and lifecycle management documents.
• Prepare for health authority interactions by developing and reviewing necessary documentation.
• Manage global labeling strategies and documents, ensuring compliance and consistency.
• Lead cross-functional labeling teams, facilitating discussions on strategies and content.
• Ensure adherence to current regulations related to regulatory strategy and labeling activities.

What You Will Bring

• Bachelor's degree in life sciences or related field; an advanced degree is preferred.
• Experience in Regulatory Affairs strategy and Regulatory Product Information Labeling (e.g., CCDS, USPI, SmPC).
• For Associate Director: minimum of 6 years in regulatory strategy and labeling.
• For Senior Manager: minimum of 4 years in regulatory strategy and labeling.
• Strong knowledge of drug development, FDA, EMA, and ICH guidelines.
• Excellent communication and organizational skills.
• Ability to work independently and in teams.
• Positive, proactive attitude.
• Proven ability to manage multiple projects and resolve regulatory issues.
• Effective interpersonal skills.

We encourage candidates who may not meet every requirement to apply. We value diversity and are committed to an inclusive environment where everyone can thrive.

Work Location

This role is location-agnostic. You can work remotely in the US or hybrid at our Cambridge headquarters, with hybrid schedules typically less than 3 days onsite. Remote employees may need to travel for company events.

What We Will Offer

• Deliberate professional development.
• Flexible work arrangements to suit individual needs.
• Comprehensive benefits package.
• Competitive salary and performance-based incentives.
• Supportive and inclusive workplace culture.
• Community involvement and support initiatives.