Manager/Sr. Manager of Regulatory Affairs

Job Code: GRMRA
Category: Medicinal Chemistry

 

To apply, send email with a subject of “Job Code GRMRA” to careers@ironwoodpharma.com Please include a CV and cover letter with your email message.

 Position description:

The Manager of Regulatory Affairs participates in the development and implementation of regulatory strategy for specific programs. Working in a team environment, the Manager will be responsible for planning and coordinating all aspects of regulatory submissions necessary to support clinical trials and product registration. The Regulatory Affairs Manager will represent the department on multidisciplinary product development teams.

 Responsibilities:

 Works with the Sr. Director to implement the regulatory strategy to move our products through development and regulatory approval Assesses and communicates regulatory requirements for clinical, preclinical and CMC submissions and programs to assure that all development activities are in compliance with applicable regulations and guidelines  — This will entail keeping abreast of changes and meaningful trends in the regulatory environment in the US and pertinent international jurisdictionsParticipates on project teams or subteams for the planning of activities needed to meet development program objectives —  This includes preparing and managing timelines for all regulatory submission such as initial INDs, IND amendments, CTx, NDAs, meeting requests, briefing books etc.Serves as primary liaison with regulatory authorities and participates in meetings with regulatory agenciesWrites FDA correspondence, meeting minutes, and introductory sections of regulatory submissionsReviews documentation associated with regulatory submissions such as clinical study reports, preclinical reports and CMC reports and informationWorks with the Regulatory Operations to develop submissions in electronic and legacy formatCooperates with the regulatory team and the cross-functional team to promote an environment of knowledge sharing and team effectiveness

 

  Requirements:

§ Knowledgeable and experienced in interpretation of regulations and guidelines related to drug development

§ Capable of strategic thinking and proposing innovative solutions to regulatory problems

§ Demonstrates excellent teamwork and communication skills with ability to impact and influence the decisions of a team

 

Minimum Education Requirements

 Bachelor's Degree in chemistry, biology or health-related major. Advanced degrees are desirable but not required.At least 5 years experience in regulatory affairs in the drug industry.Experience with original IND or NDA submissions.

 

 

 

Ironwood Pharmaceuticals is an equal opportunity employer welcoming diversity in our workforce.