Regulatory Strategist

Summary: 

We are seeking a highly motivated and experienced Regulatory Strategist to join our team. Reporting to the Director of Quality, this role involves a blend of regulatory (70%) and quality (30%) responsibilities, including quality assurance and external vendor quality. The ideal candidate will have a strong background in biologics and experience managing regulatory processes through multiple phases, from clinical to commercial. This position is based on-site in San Antonio, TX, five days a week.

Responsibilities:

• Develop and execute regulatory strategies for product development and approval.
• Ensure compliance with regional and global regulatory requirements.
• Collaborate with cross-functional teams to support product development and regulatory submissions.
• Prepare and review regulatory documents, including INDs, NDAs, and BLAs.
• Provide regulatory guidance and support to project teams throughout the product lifecycle.
• Monitor and interpret regulatory guidelines and policies and communicate changes to relevant stakeholders.
• Participate in regulatory agency meetings and negotiations.
• Manage timelines and deliverables for regulatory submissions.
• Oversee quality assurance and external vendor quality activities.

Qualifications:

• Bachelor’s Degree in Science or a related discipline.
• Minimum of 4 years of experience in the pharmaceutical or biotechnology industry.
• At least 2 years of relevant experience in regulatory affairs, both regionally and globally.
• Familiarity with INDs, NDAs, and BLAs (submission experience not required).
• Experience in early and late-stage development of multiple modalities.
• Strong knowledge of regulatory requirements and guidelines.
• Excellent communication and interpersonal skills.
• Ability to work effectively in a team environment.
• Strong organizational and project management skills.
• Background in biologics and experience managing regulatory processes through multiple phases, supporting clinical to commercial stages.
• Advanced degree in a related field.
• Experience with regulatory submissions in multiple regions.
• Knowledge of current regulatory trends and issues.