Senior Associate/Manager, Regulatory Affairs at Cambridge

Job Description

Job Number: 414838

Senior Associate/Manager, Regulatory Affairs

Regulatory Affairs Senior Associate/Manager will be responsible for managing the regulatory aspects of our development programs, including the preparation and submission of documents to regulatory agencies. This position will be responsible for providing regulatory guidance and oversight for compounds at various stages of development. Responsibilities include providing regulatory leadership to multidisciplinary project teams, and management of submissions and associated timelines.

Responsibilities

• Coordinate and prepare regulatory submissions to health authorities including FDA, EMA and other national authorities to support clinical trials
• Coordination and preparation of all regulatory submissions including INDs/CTAs, annual reports, study protocols, study reports, investigator brochures, new investigator information, IMPDs, safety reports, etc.
• Provide regulatory support to the clinical study teams (review clinical protocols, informed consent forms, Investigators Brochures, and site documentation)
• Monitor regulatory requirements to assure programs are in compliance with applicable regulations and standards
• Develop and maintain regulatory knowledge of US, EU and ROW regulations
• Coordinate and prepare responses to requests for information from health authorities
• Serve as a liaison with FDA and other regulatory agencies, in coordination with regional regulatory representatives (internal or CRO) on a global basis.
• Represent the RA function on assigned cross-functional clinical study teams
• Manage external vendors and CROs
• Provide analyses of regulatory guidance documents, regulations, or directives that impact Regulatory Affairs CMC and advice personnel in other departments regarding their applicability.
• Assess regulatory impact on site and process related changes in change control management system.

Qualifications

• BA/BS in Life Science/Health related degree
• At least 3 years of Regulatory Affairs experience
• Knowledge and understanding of global regulatory regulations and guidelines
• Previous experience in the preparation and submission of regulatory documents for IND/IMPD/CTAs
• Experience with investigational products
• Ability to work in a cross-functional team environment and a flexible team-oriented perspective
• Strong attention to detail and the ability to handle multiple tasks
• Excellent organizational, computer and documentation skills
• Strong interpersonal skills and the ability to deal effectively with various team members including medical, scientific and manufacturing staff

Job Requirements

 
Country: USA, State: Massachusetts, City: Cambridge, Company: Advanced Clinical.