Principal Scientist, Regulatory Liaison – Immunology

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

📋 Description

• Formulate global product regulatory strategies for designated indications to enhance labeling and achieve the quickest approval time.

• Evaluate regulatory and competitive environments to define global regulatory strategies that promote expedited market entry and tailored product labeling.

• Deliver expert guidance as the Global Regulatory Lead to Product Development Teams.

• Act as the regulatory liaison for products both within and outside of GRACS throughout the drug lifecycle.

• Direct the Global Regulatory Team, ensuring coordinated cross-functional regulatory support for development initiatives and marketed products.

• Oversee the preparation, submission, and follow-up with regulatory agencies and subsidiaries for applications and submissions.

• Execute regulatory reviews and grant final approval for submissions and related documentation.

• Assess and approve local registration study protocols as necessary for marketing authorization in secondary markets.

• Engage independently with regulatory agencies, including the FDA and EMA, through meetings, teleconferences, and written communications.

• Align regional regulatory strategies and submissions with Regulatory Affairs Europe and local affiliate teams.

• Review global marketing applications, clinical study reports, protocols, and investigator brochures.

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

• Take part in regulatory due diligence for licensing candidate evaluations.

• Independently oversee complex projects as the accountable global point of contact.

⛳️ Requirements

• B.S. or M.S. with at least 7 years of relevant drug development experience, primarily in regulatory, OR M.D. or PhD/PharmD with a minimum of 5 years of relevant drug development experience, including three years in regulatory.

• Strong strategic thinking, problem-solving abilities, and a mindset geared towards continuous learning.

• Proficient written and verbal communication skills.

• Capacity to influence, lead, and negotiate across various levels and functions.

• Experience leading or supporting direct interactions with major Health Authorities, such as the FDA and EMA.

• Proven expertise in leading regulatory submissions across global regions.

• Preferred therapeutic area expertise in immunology.

• Experience with both small and large molecules preferred.

• Regulatory affairs experience in primary markets (U.S., EU, Japan, China) preferred.

• Background in drug development, global regulatory, pharmaceutical industry, pharmaceutical research, product registrations, regulatory affairs management, regulatory communications, regulatory processes, regulatory strategies, regulatory submissions, and strategic leadership.

• Immunology expertise preferred.

• Eligibility for residency in the U.S. and Puerto Rico required.

• Visa sponsorship is not available.

🏝️ Benefits

• Annual bonus.

• Long-term incentive, if applicable.

• Medical, dental, and vision healthcare.

• Additional insurance benefits for employees and their families.

• Retirement benefits, including 401(k).

• Paid holidays.

• Vacation.

• Compassionate and sick days.

• Remote work arrangement.