Director, Global Regulatory Affairs — Ex-US

Larimar Therapeutics, Inc.; Philadelphia (Philadelphia County); On-site; USD 180,000 - 240,000; Full time

Job summary

Larimar Therapeutics, Inc. in Philadelphia, PA, seeks a Director, Regulatory Affairs, ex-US, to steer global regulatory strategy for products in development in European and other regions.

You will be a key member of project teams, reporting to the Regulatory Affairs Senior Director, driving timely submissions and compliance. The role requires 5–8 years in Regulatory Affairs with EMA/MHRA exposure, strong GxP understanding, and excellence in communication and project management.

Qualifications

• Bachelor degree required; 4-year undergrad minimum.
• 5 to 8 years in Regulatory Affairs within pharma; EMA/MHRA experience preferred.
• Understanding of GxP and quality principles.
• Ability to research global regulatory guidance (nonclinical, clinical, CMC).
• Experience drafting/reviewing global regulatory submissions (INDs, CTAs, MAAs).
• Excellent communication, time management, and project management skills.
• Detail-oriented with a can-do attitude.

Responsibilities

• Define, develop and lead global regulatory strategies for ex-US projects.
• Provide tactical advice to teams to achieve timely submissions and compliance.
• Lead regulatory submissions to ex-US authorities.
• Collaborate with Commercial, Medical, Legal, Compliance on advertising/promotional materials and OPDP submissions.
• Prepare impact assessments of global regulatory intelligence including ICH and global guidance.
• Develop internal regulatory procedures and practices.
• Work with RA Sr. Director and back up to other regions.

Skills

Regulatory affairs

EU agencies

GxP knowledge

Regulatory submissions

Regulatory intelligence

Communication skills

Attention to detail

Education

4-year undergraduate degree

Job description

Larimar Therapeutics, Inc. in Philadelphia, PA, seeks a Director, Regulatory Affairs, ex-US, to steer global regulatory strategy for products in development in European and other regions.

You will be a key member of project teams, reporting to the Regulatory Affairs Senior Director, driving timely submissions and compliance. The role requires 5–8 years in Regulatory Affairs with EMA/MHRA exposure, strong GxP understanding, and excellence in communication and project management.