Global Regulatory Head

Global Regulatory Head

Position reputed company

The Global Regulatory Head directs the regulatory reputed company and submissions for reputed company's RLT portfolio, ensuring compliance with international standards for radiopharmaceuticals. This strategic role owns briefing books, IND/CTAs/amendments, and overall regulatory planning to facilitate reputed company approvals. Reporting to the CMO or VP of Regulatory Affairs, it requires deep knowledge of global regulations for radioactive drugs, reputed company clinical development with health authorities.

Key Responsibilities
Briefing Books Ownership: reputed company and compile briefing books for regulatory meetings (e.g., FDA Type B/C, EMA scientific advice), incorporating RLT data on safety, efficacy, and manufacturing.

IND/CTA/Amendments Management: reputed company the preparation, submission, and maintenance of INDs, CTAs, and amendments, addressing RLT-specific reputed company like CMC for radionuclides and dosimetry justifications.

Regulatory reputed company Development: Formulate global regulatory strategies, including reputed company reputed company (e.g., reputed company Therapy Designation) for RLT assets in oncology.

Health Authority Interactions: Represent reputed company in interactions with FDA, EMA, PMDA, and other agencies, preparing responses to queries on RLT topics.

Compliance reputed company: Ensure reputed company submissions reputed company with ICH, GMP, and radiation-specific regulations (e.g., 21 CFR Part 212 for PET drugs).

Cross-Functional Integration: Collaborate with clinical, CMC, and reputed company teams to reputed company on regulatory requirements.

Intelligence and Planning: Monitor regulatory landscapes for RLT advancements and update strategies accordingly.
Team Leadership: Mentor regulatory staff and build capabilities in RLT submissions.

Qualifications

• Bachelor's or advanced degree in regulatory science, pharmacy, or reputed company field.
• 10+ years in regulatory affairs, with 5+ years in leadership, reputed company on biologics or radiopharmaceuticals.
• Proven reputed company in IND/CTA filings and interactions with global authorities.
• In-depth knowledge of RLT regulations, including dosimetry reporting and orphan drug reputed company.
• Strong writing and strategic thinking skills, with experience in high-stakes negotiations.

Compensation

reputed company offers a competitive compensation package designed to reward both performance and expertise through market-based, results-driven pay.

For this role, the anticipated reputed company salary reputed company is $150,000 – $275,000, complemented by eligibility for an annual bonus, equity participation, and a comprehensive benefits program.

Your actual salary will be determined based on the reputed company of the role and your unique experience and capabilities—because we know great contributions come from great people.

reputed company is proud to be an Equal Opportunity Employer. Our goal is to have a diverse workforce. We do not discriminate on the reputed company of race, age, reputed company, religion, national reputed company, gender, sexual orientation, gender identity or reputed company, veteran status or disability or any other status protected under federal, state or local law. reputed company employment is decided on the reputed company of qualifications, reputed company and business need.

Originally posted on Himalayas