Sr. Director, Regulatory Affairs

Enveda; Boulder (CO); Remote; USD 80,000 - 100,000; Full time

Job summary

A forward-thinking company is seeking a Sr. Director of Regulatory Affairs to spearhead drug development initiatives. This pivotal role involves leading the regulatory strategy, ensuring compliance with FDA regulations, and preparing critical submission packages. The ideal candidate will have a strong background in FDA regulatory affairs within the biotech or pharma industry, and will excel in communication, representing the company in regulatory meetings. Join a dynamic team that values diversity and fosters a respectful workplace culture, where your expertise will play a crucial role in advancing innovative drug development projects.

Qualifications

• Experience in FDA regulatory affairs in biotech or pharma.
• Strong communication skills for regulatory meetings.

Responsibilities

• Lead the regulatory affairs strategy for drug development.
• Prepare and submit IND applications and NDA submissions.

Skills

FDA regulatory affairs

Communication skills

Drug development strategy

Job description

Sr. Director, Regulatory Affairs

Boulder, CO

Drug Development – Drug Development Leadership

Full-time / Remote

Job Responsibilities

1. Lead the regulatory affairs strategy for drug development.
2. Prepare and submit IND applications and NDA submissions.
3. Ensure compliance with FDA regulatory requirements.
4. Represent the company in meetings with regulatory authorities.
5. Utilize ethnopharmacological evidence and Real World Data to support FDA approval processes.

Qualifications

1. Experience in FDA regulatory affairs within the biotechnology or global pharma industry.
2. Familiarity with preclinical studies, toxicology, clinical, and CMC requirements.
3. Proven track record in preparing submission packages.
4. Strong communication skills for representing the company in regulatory meetings.

Additional Information

Enveda believes in a respectful workplace culture. We value diversity and invite you to voluntarily provide demographic information.