The Head of Regulatory Affairs is responsible for leading and developing regulatory strategies, ensuring compliance with global and regional regulations, and managing interactions with health authorities. This hands-on role involves developing regulatory submissions, influencing policy, and supporting business objectives through timely actions. When appropriate, consider innovative strategies to expedite development of Elion's investigational products with ability to evaluate and communicate regulatory risk on path chosen. This position reports to the President/Chief Executive Officer.
Responsibilities
Functions as primary contact for interfacing with Health Authorities (HA) such as FDA and EMA, including:
Leads HA interactions, including, internal planning and preparing for formal meetings with regulatory agencies and interpreting HA feedback from these interactions.
Maintains record of all HA interactions (emails, notes of phone calls, correspondence)
Regulatory Operations:
Implement and oversee effective global regulatory operations and submissions
Maintain log of all regulatory submissions
identify potential risks and mitigation
Regulatory Strategy and Leadership:
Monitors and interprets evolving regulatory policies, guidances, and precedents, advising leadership on potential impacts and risk.
Anticipate issues and guide cross-functional teams on risk mitigation strategies for any development challenges
Act as the regulatory lead on relevant project teams to define and execute development strategies.
Ensure cross-functional alignment among stakeholders involved during key steps & stages within and across multiple projects simultaneously
Lead the development and preparation of high-quality global submissions (including IND, CTAs, NDAs, and MAAs) for early and late-stage programs in collaboration with project teams to support and accelerate clinical development and regulatory approval.
Directs time, tone, and content of interactions with the respective global regulatory Health Authorities (HA) including the request, preparation and execution of meetings with regulatory authorities for product specific issue and policy related issues.
Manage/work with consultants and contractors as needed. Proactively identify resource gaps and provide recommendations to address.
Minimum Qualifications
B.A./B.S. required; M.S., Ph.D., PharmD, MD, or other related advanced scientific degree strongly preferred
Over 15 years of progressive advancement within global regulatory affairs in the pharmaceutical /biotech industry
Prior in-depth regulatory experience in drug development with demonstrated leadership in lifecycle management process and successful submissions to FDA (e.g., INDs, briefing packages, NDAs) and other regulatory agencies (e.g., EMA)
Thorough understanding of the drug development process along with knowledge of current regulatory legislation (ICH, FDA, EMA) industry trends, developing regulations and guidelines, as well as health care business practices in the global arena
Familiarity with Chemistry, Manufacturing, and Control (CMC), Pharmacovigilance and Quality, related matters, and their intersection with Regulatory Affairs
Ability to manage in a consensus environment through teamwork, trust and shared expectations, influencing strategic direction of complex global regulatory issues, solicit information, listen well, persuade others, make recommendations that feed important company decisions and shape outcomes
Flexible and dynamic interpersonal approach, entrepreneurial by nature, a collaborative team player who works well with internal & external team members and stakeholders
Outstanding written, oral, organizational, presentation and people skills
Ability to travel domestically and internationally
The content of this position description provides a summary of the general nature of the job and may include other duties as assumed or assigned. Elion Therapeutics reserves the right to change this description at any time and require the employee to perform other tasks as required due to business needs.