Principal Consultant, Regulatory Strategy

Job overview

The Principal Consultant, Regulatory Strategy role is listed in Miami, FL; the posting does not specify whether the work is onsite, hybrid, or remote. The anticipated base salary is $230,000–$300,000 per year. Opus Regulatory provides regulatory consulting to biotechnology and pharmaceutical clients across areas including regulatory strategy, CMC, labeling, advertising and promotion, medical review, and medical information. The consultant advises client teams on regulatory pathways and leads strategy and regulatory activities across product development. The role also provides quality oversight, mentors consultants, and contributes to internal tools and practices so clients can navigate regulatory requirements and health authority interactions.

What you'll do

• Advise client teams on development pathways, regulatory requirements, submissions, and health authority interactions
• develop risk-informed strategies
• identify regulatory issues and recommend mitigation
• lead regulatory planning and submission coordination
• author, review, and oversee regulatory documents
• prepare for and participate in health authority meetings
• direct responses to agency questions
• represent Regulatory Affairs on cross-functional teams
• monitor regulatory changes
• oversee client deliverables
• mentor consultants
• contribute to internal tools and best practices.

What we're looking for

Skills & competencies

principal consultant

regulatory strategy

regulatory affairs

pharmaceuticals

biotechnology

fda

ema

regulatory submissions

client advisory

miami fl

opus regulatory

$230k–$300k/year

Work arrangement

• Weekend coverage required

Benefits & perks

• Medical, dental, vision, and prescription coverage
• life insurance
• short-term disability
• employee assistance program
• 401(k)
• 20 vacation days, 5 sick days, and 10 paid company holidays annually.

Why this role

Requires at least 15 years of progressive Regulatory Affairs experience, including at least 10 years focused on regulatory strategy; consulting experience may substitute for some industry experience.

About the employer

Opus Regulatory is hiring for this role. Industry: Administrative Management and General Management Consulting Services. Sector: 54.