REGULATORY AFFAIRS PROFESSIONALS at Boston

Job Description

WE ARE LOOKING FOR EXPERIENCED REGULATORY AFFAIRS PROFESSIONALS OF ALL SPECIALTIES AND LEVELS NATIONWIDE!!
 

Under general supervision, the Regulatory Affairs Specialist will develop, coordinate, review, and prepare documentation packages for pharmaceutical regulatory submissions (primarily US). These submissions include INDs, NDAs, ANDAs, sNDA/sANDAs, CBEs, Annual Reports, and PSURs. Act as FDA liaison for assigned projects. Prepare for agency interactions, such as FDA meetings, by writing and organizing associated documentation, including letters and briefing packages. Review and advise on manufacturing and control changes for marketed products, labels, and clinical materials for products in development.

Provide regulatory assessment and support, including the following activities: Evaluate and assess regulatory impact of proposed product changes. Contribute to strategic planning as regulatory representative on interdepartmental drug development teams. Support product development teams by interpreting and strategically applying regulations, guidances, and available research/information. Plan, prepare, and submit to FDA and other appropriate Health Authorities varied regulatory filings and correspondence. Keep to internal and federal timelines, and ensure that content, quality, accuracy and format of submission comply with applicable laws, regulations, and corporate standards. Critically review all types of documents for regulatory submission, including product labeling and promotional and advertising material. Conduct regulatory intelligence as required for in-licensing candidates and products in development. Ensure that all submission documentation, record keeping, and reporting remain in compliance with regulatory filings and in accordance with current regulatory requirements. Maintain awareness of all current, pertinent regulations, guidelines, policies, procedures, and practices. Analyze changes and updates, and advise and provide recommendations to the department and interested personnel as needed. Participate in departmental continuous improvement activities. Make recommendations for process improvements for efficiency and accuracy of drug submissions and other processes. Enhance implementation of eCTD system by restructuring document format with new submissions. Other duties as assigned 

 

Job Requirements

Minimum requirements include a BA/BS degree in a scientific discipline; graduate degrees a plus. 5 to 8 years regulatory experience in the pharmaceutical or biologics industries. Demonstrated working knowledge of scientific principles and regulatory requirements is essential, as well as the ability to interpret and strategically apply such knowledge. Previous experience in preparation of RA documents is required. Able to work independently with minimal direction. Able to work collaboratively in a team setting. Highly detail-oriented, well organized, and driven to meet deadlines and program goals. Excellent interpersonal, verbal, and written communication skills, including the ability to make effective and persuasive presentations. Good computer skills with knowledge of Microsoft Word (excellent), Excel (good), and Project (basic) and experience with Word templates. Prior experience with eCTD submissions highly preferred.
Country: USA, State: Massachusetts, City: Boston, Company: Valesta Clinical Research Solutions.