Director, Regulatory Affairs — Global Ex-US Strategy

Larimar Therapeutics, Inc.; Philadelphia (Philadelphia County); On-site; USD 180,000 - 280,000; Full time

Job summary

Larimar Therapeutics, Inc. seeks a Director, Regulatory Affairs, Ex-US to shape global regulatory strategy for products in development across Europe and other regions.

You will lead submissions, provide tactical guidance to cross-functional teams, and ensure alignment with Larimar's global regulatory plan. The role reports to the Regulatory Affairs Senior Director and collaborates with Commercial, Medical, Legal and Compliance to prepare advertising materials and regulatory submissions while

Qualifications

• Minimum of 4-year undergraduate degree.
• 5 to 8 years experience in Regulatory Affairs in the pharmaceutical industry; EMA, MHRA experience preferred.
• Understanding of GxP systems and quality principles.
• Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to aid in global regulatory strategies.
• Experience with preparation of documents for global Health Authority submissions including IND amendments, CTA submissions, and global marketing authorization packages.
• Excellent communication, time management and project management skills.
• Continuous quality improvement mindset and attention to detail.
• Can-do attitude, flexibility and mental agility.

Responsibilities

• Lead strategies to maximize global regulatory success towards program objectives for complex development projects.
• Provide tactical advice to project teams and stakeholders to achieve timely submissions and approvals while ensuring compliance.
• Lead regulatory submissions to ex-US health authorities to align with Larimar’s regulatory strategy.
• Collaborate with Commercial, Medical, Legal, Compliance on advertising and promotional materials and OPDP submissions.
• Prepare Larimar regulatory impact assessments of global guidance, initiatives, and advisory committee activities.
• Develop internal regulatory procedures and practices.
• Work closely with RA Sr. Director and serve as backup to other global region regulatory activity.

Skills

Regulatory affairs

EMA familiarity

Global regulatory strategy

IND submissions

Communication

Project management

GxP knowledge

Education

Bachelor's degree

Job description

Larimar Therapeutics, Inc. seeks a Director, Regulatory Affairs, Ex-US to shape global regulatory strategy for products in development across Europe and other regions.

You will lead submissions, provide tactical guidance to cross-functional teams, and ensure alignment with Larimar's global regulatory plan. The role reports to the Regulatory Affairs Senior Director and collaborates with Commercial, Medical, Legal and Compliance to prepare advertising materials and regulatory submissions while