Senior Director Regulatory Affairs

This biopharmaceutical company is developing and commercializing an innovative pipeline of cancer therapies and immunology treatments. They are seeking a Regulatory Affairs Senior Director who can develop and implement global regulatory strategies for an approved immunology product and support their portfolio of oncology programs. Reporting into the SVP of Regulatory & Quality, you will manage assets through all phases of development and work closely with Health Authorities. This company offers flexible work arrangements, a strong cash position, and a collaborative company culture. With two approved products and an innovative pipeline, now is an exciting time to join this growing organization! Responsibilities:Serve as Global Regulatory Lead for an approved immunology product and support a portfolio of oncology programs.Ensure the development and execution of regulatory strategies for the assigned products/projects.Serve as a strategic partner for internal cross functional stakeholders both within and external to the regulatory organization.Ensure strategic messaging and content of global regulatory dossiers. May serve as the primary regulatory interface with the Asset Strategy Team and sub teams.Represents company to regulatory health authorities, e.g. FDA, for all products and businesses.Lead the preparation of submissions, which may include INDs, Briefing Documents, Orphan Drug Applications, and Marketing Applications, etc. Work with cross-functional groups to define contributions to submissions. Lead regulatory submission teams for projects assigned.Prepare company team for health agency meetings, as required.Serve as the primary interface with Regulatory CROs for coordination and preparation of submissions.Responsible for maintaining a working knowledge of the global regulatory environment in relevant disease areas and identify and communicate the implications of identified regulatory trends that may impact the business.Maintain knowledge of global competitive landscape, regulatory environment, regulations and guidance.Prepare, plan and implement new processes and policies to improve efficiency of the Company.Qualifications:Bachelor degree in a scientific discipline. Advanced degree (MS, PharmD or PhD) preferred.10+ years pharmaceutical industry experience, including 8+ years in Regulatory Affairs roles.Must have Regulatory experience in the oncology therapeutic area. Experience with Rare Disease or Immunology a plus.Must have drug development experience in the US and EU/UK/EEA. Experience in Asia PAC, a plus.Experience directly interfacing with health authorities in a major market.Experience in multiple phases of development is required.Knowledge of global regulatory guidelines as they relate to the overall global regulatory strategy.Cross functional partnering skills, team-oriented and ability to drive outcomes are necessary skills in the environment.Strong business acumen and strategic thinking capabilities, able to navigate complex challenges and contribute to the business's long-term vision.Must be solution oriented with demonstrated skills to innovate, analyze, solve problems, and foster a collaborative working environment.Excellent communication skills, with the ability to articulate complex issues clearly and persuasively to a diverse stakeholder group. Must be flexible and comfortable with ambiguity in a fast-paced, small company environment. This is a hybrid position and the Senior Director must be in the office 1-2 times per quarter. Our client has offices in the NY/NJ area and also in the Boston area. Candidates in the Northeast are strongly preferred.The budgeted salary range for this position is $250,000 to $275,000 plus an annual target bonus, equity, and comprehensive benefits. Actual salaries may be based on a number of factors including, but not limited to, a candidate's skill set, experience, education, and other qualifications. Posted salary ranges do not include incentive compensation or any other type of renumeration.

Created: 2025-01-15