The most important aspect of the position of the Assistant/Associate Director of Regulatory Affairs is being responsible for managing the more complex regulatory aspects of projects, including the preparation and submission of correspondence and applications to regulatory agencies worldwide, with an emphasis on FDA premarket submissions. This person will assist the Regulatory Affairs Director or VP of Regulatory Affairs in the development of appropriate responses to FDA enforcement actions (e.g. Warning Letters Responses).
POSITION SUCCESS FACTORS
- Ability to work with internal employees and external clients simultaneously
- Ability to manage multiple projects and deliverables in a timely fashion
- Regulatory Lead on product development team(s) in some cases, in others based upon experience and level of complexity of the technology might work under direction of a more senior or more qualified Regulatory Lead. Provides regulatory input and advice and ensures regulatory compliance throughout the product lifecycle. Defines regulatory submission strategies throughout product development; manages submission timelines, interprets applicable regulations and guidelines for product team use; keeps project team and DLSS management informed of regulatory decisions, issues, potential problems, and new regulations.
- Works closely with other Company department leads to ensure regulatory compliance in the requirements and preparation of submissions to FDA and international regulatory authorities.
- Coordinates timely submissions and amendments consistent with company strategies, regulatory requirements and timelines. Areas of expertise include preclinical, clinical, labeling development, and safety reporting.
- As appropriate, manages the entire meeting process with relevant regulatory authorities- including submission of request, coordination of briefing package preparation, meeting facilitation, and minute compilation.
- Communicates with regulatory authorities as needed.
- Prepares and writes complex submissions and other regulatory filings as required.
- Evaluates new regulatory intelligence, including new and revised regulations and guidance, assesses potential impact on the organization and communicates to Senior Management
- Ensures all clients and DLSS management are immediately and properly informed of any regulatory, compliance, project, or personnel risks to projects, processes, and to the organization.
- Monitor new drug, biologic, medical device approvals in relevant therapeutic areas and communicate appropriately.
- Evaluate and recommend project specific regulatory filing strategies.
- Cross functional collaboration to ensure corporate objectives and milestones are met in a timely manner.
- Prepare policies and SOPs in accordance with company and regulatory requirements.
- Assisting the VP of Regulatory Affairs and/or Regulatory Affairs Director with other duties as assigned.
- Managing, training and mentoring regulatory associates and/or quality specialists.