Global Regulatory Affairs Director

Larimar Therapeutics, Inc.; Philadelphia (Philadelphia County); On-site; USD 120,000 - 150,000; Full time

Job summary

A biotechnology company in Philadelphia is seeking a Director of Regulatory Affairs to lead global regulatory activities for product development. The candidate should possess extensive experience in regulatory affairs, particularly with European agencies, and have strong project management and communication skills. Responsibilities include defining regulatory strategies, leading submissions, and collaborating with various teams to ensure compliance with regulations. This position is critical for advancing the company's product pipeline and maintaining regulatory standards.

Qualifications

• 5 to 8 years’ experience in a Regulatory Affairs role in the pharmaceutical industry.
• Experience with EMA, MHRA and other local European agencies preferred.
• Ability to research global regulatory guidance.

Responsibilities

• Define, develop and lead global regulatory strategies.
• Provide tactical advice to project teams and stakeholders.
• Lead regulatory submissions to ex-US health authorities.
• Collaborate with Commercial, Medical, Legal teams.
• Develop internal regulatory procedures and practices.

Skills

Regulatory Affairs expertise

Excellent communication skills

Project management skills

Understanding of GxP systems

Flexibility and mental agility

Education

Undergraduate degree

Job description

A biotechnology company in Philadelphia is seeking a Director of Regulatory Affairs to lead global regulatory activities for product development. The candidate should possess extensive experience in regulatory affairs, particularly with European agencies, and have strong project management and communication skills. Responsibilities include defining regulatory strategies, leading submissions, and collaborating with various teams to ensure compliance with regulations. This position is critical for advancing the company's product pipeline and maintaining regulatory standards.