Associate Director, Regulatory Affairs
Larimar is seeking a Regulatory Affairs Associate Director to support the global regulatory strategy and regulatory activities for products in development. The Regulatory Affairs Associate Director will be a key member of project teams. The role reports to the Regulatory Affairs Senior Director.
- Interface with other Larimar departments and outside consultants to obtain timely regulatory deliverables and ensure regulatory compliance
- Advise other departments on regulatory health authority requirements for product development and regulatory submissions
- Plan, author and review high quality regulatory submissions
- May serve as back up to Regulatory Operations for filing regulatory submissions
- Maintain ongoing awareness of global regulations and guidelines relevant to projects
- Develop internal regulatory procedures and practices
- Minimum of 4-year undergraduate degree
- 8+ years experience in a Regulatory Affairs role in the pharmaceutical industry
- 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.
- Knowledge of eCTD structure, components and basic regulatory operations which support in-house regulatory submissions
- Experience with preparation (authoring and review) of documents for global Health Authority submissions including but not limited to IND amendments, CTA submissions and Health Authority Meeting packages and 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