Larimar Therapeutics, Inc.

Director, Regulatory Affairs, Ex-US

Larimar Therapeutics, Inc. • $120K — $150K *
Philadelphia, PA 19120In-Person
Pharmaceuticals & Biotech
5 - 7 years of experience
More than 3 months ago
Job Overview by Ladders

Qualifications

  • 4-year undergraduate degree required
  • 5 to 8 years of Regulatory Affairs experience in the pharmaceutical industry
  • Experience with European regulatory agencies (EMA, MHRA) preferred
  • Knowledge of GxP systems and Quality principles
  • Proven ability to prepare documents for global Health Authority submissions
  • Strong communication, time management, and project management skills
  • Attention to detail and continuous improvement mindset

Responsibilities

  • Define, develop, and lead global regulatory strategies for complex projects
  • Provide tactical advice for timely and efficient program development
  • Lead regulatory submissions to ex-US health authorities
  • Collaborate on advertising and promotional materials and OPDP submissions
  • Assess global regulatory intelligence and impact on projects
  • Develop internal regulatory procedures and practices
  • Assist the Regulatory Affairs Senior Director with global activities

Benefits

  • Equal opportunity employment policies
  • Commitment to developing and retaining qualified talent
  • Diverse work environment fostering professional growth
Full Job Description
Position Summary:

Larimar is seeking a Director, Regulatory Affairs, to support the global regulatory strategy and drive regulatory activities for products in development specific to European and other global regions. The Regulatory Affairs Director will be a key member of project teams. The role reports to the Regulatory Affairs Senior Director.

Job Duties/Responsibilities:
  • The Director of Regulatory Affairs ex-US will be a key member of project teams to define, develop and lead strategies to maximize global regulatory success towards achievement of program objectives for complex development projects
  • Provide tactical advice to project teams, functional heads and other stakeholders to achieve timely and efficient program development, submissions and approval, while ensuring compliance with applicable global regulatory requirements
  • Lead regulatory submissions to ex-US health authorities (medicine regulatory and reimbursement groups) to ensure high-quality, timely submissions that align with Larimar's global regulatory strategy and plan
  • Collaborate with colleagues in Commercial, Medical, Legal, Compliance and other expertise areas in creation of advertising and promotional materials as assigned; and preparation of timely OPDP submissions
  • Prepare Larimar impact assessment of global regulatory intelligence including but not limited to ICH and global Health Authority guidances, global Health Authority Pilot programs and initiatives, rare disease product approvals, and FDA advisory committee meetings
  • Develop internal regulatory procedures and practices
  • Work closely with RA Sr. Director and serve as backup to other global region regulatory activity


Requirements

Key Experience, Skills and Knowledge:
  • Minimum of 4-year undergraduate degree
  • 5 to 8 years' experience in a Regulatory Affairs role in the pharmaceutical industry, experience with EMA, MHRA and other local European agencies preferred
  • Understanding of GxP systems and Quality principles
  • Ability to research global regulatory guidance (nonclinical, clinical and CMC) and precedence to assist in the development and execution of global regulatory strategies
  • Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions, Global Health Authority Meeting packages and global marketing authorization applications
  • Excellent communication, time management and project management skills
  • Continuous quality improvement mindset and attention to details
  • Can do attitude, flexibility, and mental agility

About Larimar Therapeutics, Inc.

Larimar Therapeutics, Inc. is a clinical-stage biotechnology company focused on developing treatments for complex rare diseases. The company's lead product candidate, CTI-1601, is a recombinant fusion protein that is being developed for the treatment of Friedreich's ataxia, a rare genetic disease that causes progressive damage to the nervous system. Larimar Therapeutics was founded in 2018 and is headquartered in Philadelphia, Pennsylvania.
Learn more about Larimar Therapeutics, Inc.
Size
31 employees
Market Cap
$183.6 million
Industry
Pharmaceuticals & Biotech
Net Income
-$42.4 million
NASDAQ
LRMR
* Ladders Estimates

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