The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.
Biologics, Pharmaceuticals, Quality/Risk Management, US Regulatory Affairs
4 Year Degree
The Senior Manager, Regulatory Affairs Manager will support our global regulatory strategy and regulatory activities for products in development. This role reports to the Director, Regulatory Affairs and will be a key member of multi-functional project teams.
Responsibilities will include but are not limited to:
Interface with other departments and outside consultants to obtain timely regulatory deliverables and ensure regulatory compliance
Advise other departments on regulatory authority requirements for product development and regulatory submissions
Plan, author and review high quality regulatory submission sections
Serve as back up to the Senior Manager, Regulatory Operations for filing regulatory submissions
Maintain ongoing awareness of regulations and guidelines relevant to projects
Develop internal regulatory procedures and prac
This role requires a Bachelors degree and a minimum of 6 years of experience in a Regulatory Affairs role in the pharmaceutical industry, and a strong understanding of GxP systems and Quality principles. Experience with preparation (authoring and review) of documents for Health Authority submissions including but not limited to IND amendments, CTA submissions and Health Authority Meeting packages and marketing authorization applications is also required, as is knowledge of eCTD structure, components and basic regulatory operations which support in-house regulatory submissions. The ability to research global regulatory guidance and precedence to assist in the development and execution of global regulatory strategies with emphasis on CMC regulatory strategy, and/or specialized expertise in CMC regulatory and/or regulatory project management is desirable. The successful candidate will have excellent communication, time management and project management skills; a continuous quality improvement mindset and attention to details; and a can-do attitude, flexibility, and mental agility.
Internal Number: SMRA001
About Larimar Therapeutics
We are Larimar Therapeutics, based in the Philadelphia area, and committed to discovering and developing therapeutics to dramatically improve the lives of patients with complex rare diseases.
At Larimar we embrace everyone’s contribution to our Mission, have fun while working passionately. Our values connect us and ensure we communicate openly, treat each other with respect, help us grow from our successes and failures, and innovate.
If you are searching for a company where urgency, agility, and commitment to science win the day – we welcome you!