Sr. Scientist- PKDM-BA (Immunoassay)

Amgen; Cambridge (MA); On-site; USD 136,000 - 203,000; Full time

Job summary

Amgen seeks an Associate Regulatory Affairs Director to oversee cell therapy regulatory strategy and submissions across global regions. You will partner with senior teams to advance innovative therapies through clinical development and guide cross-functional teams on compliance.

In this leadership role, you will manage regulatory submissions and monitor evolving guidelines to support efficient development timelines across diverse markets.

Qualifications

• Bachelor's degree in scientific discipline, regulatory sciences, pharmacy, or related field.

Responsibilities

• Define stage-appropriate regulatory strategy aligned with global requirements for cell-based therapies.
• Lead planning, preparation, and submission of regulatory applications (IND, CTA, BLA, IVDR) across regions.
• Monitor evolving global and regional regulatory guidelines to support development plans.
• Participate in health authority meetings to obtain regulatory feedback and develop submission strategies.
• Develop and maintain submission delivery and content plans with stakeholder status updates.

Skills

Regulatory strategy

Regulatory submissions

Project management

Leadership

Communication

Cross-functional collaboration

Education

Bachelor's degree

Tools

Project management software

Document management software

Job description

Associate Regulatory Affairs Director overseeing cell therapy regulatory strategy and submissions across global regions. This experienced regulatory specialist will partner with senior teams to advance innovative therapies through clinical development, manage regulatory submissions, and guide cross-functional teams on compliance requirements.

Responsibilities

• Define stage-appropriate regulatory strategy aligned with global requirements for cell-based gene therapies
• Lead planning, preparation, and submission of regulatory applications across regions (IND, CTA, BLA, IVDR)
• Monitor evolving global and regional regulatory guidelines to support efficient development plans
• Participate in health authority meetings to obtain regulatory feedback and develop submission strategies
• Develop and maintain submission delivery and content plans with stakeholder status updates

Requirements

• Bachelor's degree in scientific discipline, regulatory sciences, pharmacy, or related field
• 5+years regulatory experience in biopharmaceutical industry, health authority, or equivalent
• Thorough knowledge of drug development processes and timelines
• Strong project management and leadership skills with multidisciplinary team experience
• Excellent written and verbal communication abilities
• Scientific knowledge sufficient to understand regulatory issues and facilitate discussions
• Proficiency with project management and document management software tools

Compensation: $135,624.80 - $203,437.20 USD Annual