Senior Manager, Regulatory Affairs

Jobgether

4d

About The Position

This position is posted by Jobgether on behalf of a partner company. We are currently looking for a Senior Manager, Regulatory Affairs in the United States.
This role leads regulatory strategy and execution for clinical, non-clinical, and CMC projects, ensuring compliance with global regulatory requirements. The Senior Manager, Regulatory Affairs partners with cross-functional teams to plan, prepare, and submit regulatory dossiers, including INDs, NDAs, BLAs, and annual reports, while providing expert guidance on regulatory strategy and tactics. This position requires strong project management skills, scientific expertise, and the ability to influence decision-making across internal teams. The role also involves maintaining up-to-date knowledge of FDA, ICH, and international regulations, advising on regulatory risk, and ensuring submissions meet quality and timeliness standards. By supporting both strategic and operational regulatory initiatives, this position contributes to bringing critical therapies to patients efficiently and safely. Strong communication, analytical thinking, and leadership skills are essential for success in this fast-paced, highly collaborative environment.

Requirements

• Bachelor’s degree in a scientific or related field; advanced degrees preferred.
• 7+ years of regulatory affairs experience in the pharmaceutical or biotechnology industry.
• Strong expertise with IND preparation and submissions; experience with NDAs and supplements is desirable.
• Knowledge of CTD/eCTD formatting and document publishing tools (e.g., Adobe Acrobat Professional).
• Working knowledge of FDA, ICH, GMP, GLP, GCP, and other applicable regulations; understanding of global regulatory requirements is a plus.
• Excellent oral and written communication, planning, and organizational skills.
• Detail-oriented, self-motivated, and able to manage broad responsibilities in a fast-paced environment.
• Strong analytical, problem-solving, and decision-making abilities; ability to act inclusively and foster collaboration across teams.

Responsibilities

• Plan, manage, and execute regulatory activities for assigned projects across clinical, non-clinical, and CMC domains.
• Develop and implement strategies to achieve the earliest possible regulatory approvals and clearances.
• Lead preparation, review, and timely submission of regulatory dossiers, including INDs, NDAs, BLAs, amendments, supplements, annual reports, and safety reports.
• Provide regulatory guidance to cross-functional project teams and represent regulatory affairs in project meetings.
• Ensure compliance with departmental and global regulatory requirements, including document archiving and recordkeeping.
• Collaborate with external consultants and CROs as needed to support regulatory submissions and project objectives.
• Maintain current knowledge of regulatory developments and provide recommendations to management on emerging requirements.

Benefits

• Competitive annual salary range: $139,800 – $184,800.
• Participation in annual bonus or incentive compensation plans.
• Discretionary equity awards and access to employee stock purchase plan.
• Comprehensive medical, dental, and vision coverage.
• 401(k) plan with company contributions, FSA/HSA options.
• Paid time off, holidays, and wellness programs.
• Professional development opportunities and support for continuous learning.
• Inclusive work environment emphasizing collaboration, innovation, and patient-focused impact.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level