Manager of Regulatory Affairs will be responsible for providing regulatory strategy for therapeutic candidates in the metabolic and oncology space. Responsible for working closely with the Associate Director, Regulatory Affairs to develop regulatory strategies for therapeutic candidates and global submissions and planning, coordination, and authoring of regulatory submissions.
MAJOR DUTIES AND RESPONSIBILITIES:
• Responsible for filing INDs, CTAs, briefing documents and maintenance of approved applications including authoring annual reports, amendments as needed.
• Provide regulatory representation to cross-functional product development teams.
• Lead and facilitate development of Health Authority meeting requests and briefing packages in preparation for Agency meetings
• Expected to help lead, coordinate, write, critically review and provide strategic input on regulatory filing documents (e.g. IMPD, responses to Agency requests, IND module 2 documents)
• Proactively develop regulatory strategies to support CMC, clinical and non-clinical development programs.
• Responsible for project timelines and management of regulatory submissions including authoring and preparing regulatory documentation.
• Establish, track and manage regulatory project timelines, status and documents.
• Provide regulatory assistance and review in clinical operations activities, including review of essential documents and adverse event reporting
• Perform regulatory research and stay abreast of new/emerging regulations and communicates relevant changes to management and project teams.
• Provide regulatory support for regulatory compliance activities as required.
• Develop and maintain standard operating procedures or local working practices.
EDUCATION / REQUIREMENTS:
• Minimum of Bachelor’s degree in life sciences or equivalent required. Advanced degree preferred. RAC certification preferred.
QUALIFICATIONS and EXPERIENCE REQUIREMENTS:
• A minimum of 4 years related experience in regulatory affairs with experience in oncology therapeutic space preferred
• Experience with FDA and EMA regulatory environment
• Experience with early-stage CMC submissions
• Experience in developing and submitting successful regulatory submissions with a thorough understanding of FDA regulations and ICH guidelines.
• Demonstrated ability to work effectively in a team based environment.
• Must be detail-oriented with well-developed organizational and analytical skills.
• Demonstrated excellent written, oral, communication, presentation, planning and interpersonal skills.
• Ability to manage critical projects as part of an interdisciplinary team.
• Must enjoy working in a fast-paced dynamic environment with proven ability to be flexible and adaptable.