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.