Regulatory Strategy Consultant
Employment type
Full-time
Work setting
On-site
Location
Pierre, SD
Schedule
Day shift
Posted
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Job overview
The Regulatory Strategy Consultant is a remote role based in Pierre, SD. Compensation is not specified for this position, which supports Parexel's regulatory team. This role provides strategic leadership for major regulatory decisions, authority engagement, and high-impact submissions. The consultant guides biopharmaceutical partners through regulatory pathways and lifecycle management to advance clinical development.
What you'll do
- Develop regulatory strategy across significant programs.
- Lead authority engagement models and submission strategies.
- Oversee high-impact regulatory submissions.
- Develop long-range development and lifecycle management plans.
- Collaborate with clinical and commercial teams.
- Monitor regulatory landscape changes.
What we're looking for
- Skills & competencies
- full-timeday shiftpierre sdparexelregulatory strategyconsultantremoteclinical developmentbiologicsvaccinesregulatory affairslife sciences
- Work arrangement
- Weekend coverage required
Benefits & perks
- Health, Vision & Dental Insurance, Tuition Reimbursement, 401(k) with Company match, Pet Insurance.
Why this role
Requires 10+ years of experience in regulatory affairs and experience with vaccine/biologic products.
About the employer
Parexel is hiring for this role. Industry: Administrative Management and General Management Consulting Services. Sector: 54.
Additional details
- Industry sector
- 54
- Industry
- Administrative Management and General Management Consulting Services
- Occupation code
- 11-9199.01
You'll be redirected to the employer's application page.
Listing ID: 331f9cb3-7c97-45f6-8b74-da03ed975030