Senior Director Regulatory Affairs

ClinLab Staffing; Waltham (MA); On-site; USD 300,000 - 350,000; Full time

Job summary

A leading company in the pharmaceutical industry is seeking a Senior Clinical Recruiter to lead regulatory affairs. This role involves developing regulatory strategies and mentoring professionals in a dynamic environment. The ideal candidate will possess extensive experience in biologics and a strong understanding of FDA regulations. This position requires onsite presence at least four days a week, offering a competitive salary and benefits.

Benefits

Medical Insurance

401(k)

Vision Insurance

Qualifications

• 5-7 years of biologics experience required.
• Experience with filing a BLA and managing regulatory professionals.

Responsibilities

• Developing and executing regulatory strategy.
• Optimizing global health authority interactions.
• Providing regulatory intelligence and CMC oversight.

Skills

Biologics Experience

Regulatory Strategy

FDA Knowledge

Education

PhD

PharmD

MS

Job description

1 day ago Be among the first 25 applicants

Direct message the job poster from ClinLab Staffing

Senior Clinical Recruiter at ClinLab Staffing

This is a highly visible leadership role responsible for:

• Developing and executing regulatory strategy,
• Optimizing global health authority interactions,
• Collaborating cross-functionally with internal teams,
• Providing regulatory intelligence and CMC oversight.

Required:

• Strong biologics experience (5 - 7 years),
• Experience with filing a BLA,
• Managing and mentoring regulatory professionals,
• Advanced degree in a relevant field (PhD, PharmD, MS, or equivalent),
• Immunology and/or nephrology regulatory experience preferred,
• 15+ years of regulatory affairs experience,
• Strong knowledge of FDA, EMA, PMDA, and ICH regulatory requirements for biologics and advanced therapeutics,
• Onsite at least 4 days a week.

Full JD available upon request.

Seniority level

• Director

Employment type

• Full-time

Job function

• Research

Industries

• Pharmaceutical Manufacturing and Biotechnology Research

Referrals increase your chances of interviewing at ClinLab Staffing by 2x.

Inferred from the description for this job

Medical insurance, 401(k), Vision insurance.

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