Senior Regulatory Affairs Leader: Strategy & Submissions

Groe Advisors LLC; Aliso Viejo (CA); On-site; USD 120,000 - 150,000; Full time

Benefits offered by this job

Medical insurance

401(k)

Job summary

A leading recruitment firm is seeking a Sr. Manager, Regulatory Affairs to drive regulatory strategies for innovative drug/device products. This mid-senior level role requires expertise in preparing global submissions and engaging with regulatory authorities. Ideal candidates have a strong background in life sciences and at least 6 years in Regulatory Affairs. Benefits include medical insurance and 401(k).

Qualifications

• 9+ years of experience in the life sciences industry, including 6+ years in Regulatory Affairs.
• Proven experience preparing INDs, NDAs, CTAs, and associated amendments.
• Prior involvement in regulatory interactions with FDA and/or EMA.

Responsibilities

• Drive and implement global regulatory strategies for products.
• Oversee planning and authoring of high-quality global submissions.
• Engage with global regulatory authorities, including FDA and EMA.

Skills

Regulatory strategy development

Cross-functional collaboration

Leadership and mentorship

Project management

Excellent communication skills

Education

Bachelor’s degree in a scientific discipline

Advanced degree (MS, PharmD, PhD)

Tools

Microsoft Office

Document management systems

Job description

A leading recruitment firm is seeking a Sr. Manager, Regulatory Affairs to drive regulatory strategies for innovative drug/device products. This mid-senior level role requires expertise in preparing global submissions and engaging with regulatory authorities. Ideal candidates have a strong background in life sciences and at least 6 years in Regulatory Affairs. Benefits include medical insurance and 401(k).