Biologics Reg/CMC Strategy Director (Consultant)

RegDev, Inc.; United States; On-site; USD 110,000 - 150,000; Full time

Job summary

RegDev, Inc. is looking for a seasoned Regulatory Affairs Professional to support global biotech clients. Candidates must have 10-15 years of experience in Regulatory CMC and biologics. Responsibilities include developing regulatory strategies, preparing documentation for US INDs and BLAs, and advising clients on compliance. Strong communication and critical thinking skills are crucial. The role may require some travel and offers the opportunity to work independently and collaboratively with clients.

Qualifications

• A minimum of 10-15 years’ experience in Regulatory CMC is required.
• Experience preparing and managing US and global biologics Regulatory filings is essential.

Responsibilities

• Interpret global regulatory requirements and advise clients on strategies.
• Develop and execute regulatory and RegCMC strategies.
• Lead preparation and finalization of regulatory documents for US INDs and BLAs.
• Conduct risk assessments and advise clients on mitigation strategies.

Skills

Regulatory Strategy

RegCMC biologics development

Relationship building

Critical thinking

Communication skills

Education

10-15 years’ experience in Regulatory CMC

Experience with US and global biologics Regulatory filings

Job description

RegDev, Inc. is looking for a seasoned Regulatory Affairs Professional to support global biotech clients. Candidates must have 10-15 years of experience in Regulatory CMC and biologics. Responsibilities include developing regulatory strategies, preparing documentation for US INDs and BLAs, and advising clients on compliance. Strong communication and critical thinking skills are crucial. The role may require some travel and offers the opportunity to work independently and collaboratively with clients.