Senior Principal Scientist, Regulatory Liaison

This is a fully remote position, open to applicants in New Jersey, +2 more states.

📋 Description

• Formulate and execute global regulatory strategies for designated General Medicine initiatives, particularly in Immunology development programs.

• Offer regulatory guidance to enhance product labeling and achieve the fastest approval timelines from international regulatory bodies.

• Effectively manage projects as the primary global contact for project teams.

• Engage with global regulatory agencies and subsidiaries concerning international regulatory strategies and registration prerequisites.

• Analyze regulatory and competitive environments to devise strategies that promote expedited market entry and precise product labeling.

• Act as the Global Regulatory Lead and the sole regulatory contact throughout the product life cycle.

• Direct Global Regulatory Teams to coordinate cross-functional regulatory support.

• Oversee the preparation, submission, and follow-up communications with regulatory authorities.

• Evaluate global applications and the related documentation.

• Review and authorize local registration study protocols for secondary markets.

• Conduct regulatory meetings, teleconferences, and written communications with agencies such as the FDA and EMA.

• Guide cross-functional preparations for FDA advisory committee meetings.

• Assess worldwide marketing applications, clinical study reports, protocols, and investigator brochures.

• Prepare INDs/CTAs for global trials involving investigational drugs and biologics.

• Contribute to regulatory due diligence during licensing candidate evaluations.

⛳️ Requirements

• B.S. or M.S. with at least 10 years of pertinent drug development experience, primarily in regulatory affairs, OR M.D. or PhD/PharmD with a minimum of 7 years of relevant drug development experience, including five years in regulatory.

• Proven experience leading or supporting direct engagements with major Health Authorities, such as the FDA and EMA.

• Proficiency in steering regulatory strategies across global regions.

• Experience in global regulatory affairs within key markets: U.S., EU, Japan, and China.

• Strategic mindset, adept problem-solving abilities, and a commitment to continuous learning.

• Exceptional written and verbal communication skills, with the ability to influence, lead, and negotiate across various levels and functions.

• Leadership experience in building and managing high-performing teams or projects.

• Integrity in corporate and ethical matters.

• Preferred: expertise in the therapeutic area of immunology.

• Preferred: experience with both small and large molecules.

• Preferred: previous experience in people management.

• Required skills: Drug Development, Global Regulatory, Pharmaceutical Industry, Pharmaceutical Research, Product Registrations, Regulatory Affairs Management, Regulatory Communications, Regulatory Documents, Regulatory Processes, Regulatory Strategies, Regulatory Strategy Development, Regulatory Submissions, Strategic Leadership.

• Open to residents of the U.S. and Puerto Rico only.

• No visa sponsorship available.

🏝️ Benefits

• Annual bonus.

• Long-term incentive, if applicable.

• Comprehensive medical, dental, and vision healthcare.

• Additional insurance benefits for employees and their families.

• Retirement benefits, including a 401(k) plan.

• Paid holidays.

• Vacation time.

• Compassionate leave days.

• Sick leave.

• Flexible remote work arrangements.