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Alcon

Regulatory Affairs Manager I

Lake Forest, CA · On-site

The Manager I, Regulatory Affairs Strategy (Professional Path) ), reporting to the Senior Manager of Regulatory Affairs (LLSI), is primarily responsible for coordinating regulatory affairs activities ...

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How much do regulatory affairs strategy jobs pay per hour?

As of Aug 7, 2026, the average hourly pay for regulatory affairs strategy in the United States is $56.97, according to ZipRecruiter salary data. Most workers in this role earn between $42.07 and $66.59 per hour, depending on experience, location, and employer.

What does a regulatory affairs strategy do?

A regulatory affairs strategy involves planning and implementing approaches to ensure that a company's products comply with relevant regulations and standards. It includes preparing documentation, navigating approval processes, and staying updated on regulatory changes to facilitate product approval and market access.

What are the key skills and qualifications needed to thrive in regulatory affairs strategy?

To thrive in Regulatory Affairs Strategy, you need a deep understanding of regulatory guidelines, scientific backgrounds (often with a degree in life sciences or pharmacy), and experience in regulatory submissions and compliance. Familiarity with regulatory databases, submission management systems, and certifications such as RAC (Regulatory Affairs Certification) are highly valued. Strong analytical thinking, attention to detail, and effective communication skills help professionals anticipate regulatory changes and collaborate across departments. These skills ensure that products meet global regulatory requirements efficiently, reducing approval risks and supporting successful market entry.

What is the difference between Regulatory Affairs Strategy vs Regulatory Affairs Specialist?

AspectRegulatory Affairs StrategyRegulatory Affairs Specialist
CredentialsTypically requires a degree in life sciences, regulatory affairs certification preferredSimilar credentials, often with a focus on specific regulations or regions
Work EnvironmentStrategic planning, cross-department collaboration, senior-level projectsOperational tasks, document preparation, regulatory submissions
Employer & IndustryPharmaceutical, biotech, medical device companies, often in a strategic roleSame industries, more focused on compliance and submission processes
Search & Comparison IntentUnderstanding strategic roles in regulatory affairsOperational regulatory tasks and responsibilities

Regulatory Affairs Strategy professionals focus on planning and aligning regulatory pathways with business goals, while Regulatory Affairs Specialists handle the day-to-day compliance and submission tasks. Both roles require similar credentials and work within the same industries, but differ in scope and focus.

What is regulatory affairs strategy?

Regulatory Affairs Strategy refers to the planning and execution of processes to ensure that products—such as pharmaceuticals, medical devices, or food—meet all regulatory requirements for approval and ongoing compliance in different markets. Professionals in this field develop strategies to navigate complex regulations, communicate with regulatory agencies, and help bring products to market efficiently and legally. They play a critical role in minimizing delays, reducing risks, and ensuring that products remain compliant throughout their lifecycle.

Is regulatory affairs strategy high paying?

Regulatory affairs strategy roles are generally well-compensated, especially for professionals with advanced degrees, certifications, and experience in the field. Salaries can vary based on industry, location, and level of responsibility, but they tend to be higher than average for similar roles in healthcare, pharmaceuticals, and biotech sectors.

How does a regulatory affairs strategy professional typically collaborate with cross-functional teams during product development?

Regulatory Affairs Strategy professionals play a pivotal role in product development by working closely with R&D, clinical, marketing, and legal teams to ensure products meet all necessary regulatory requirements. They provide regulatory guidance during early development stages, help interpret changing regulations, and facilitate communication between internal teams and regulatory agencies. This collaboration ensures that regulatory considerations are integrated into project timelines and strategies, reducing risks of delays or non-compliance. Effective cross-functional teamwork is essential for timely submissions and successful product launches.
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What cities are hiring for Regulatory Affairs Strategy jobs? Cities with the most Regulatory Affairs Strategy job openings:
What job categories do people searching Regulatory Affairs Strategy jobs look for? The top searched job categories for Regulatory Affairs Strategy jobs are:
Regulatory Affairs Strategy jobs near you
Infographic showing various Regulatory Affairs Strategy job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 86% Full Time, 9% Part Time, and 4% Contract. Highlights an 91% Physical, 3% Hybrid, and 6% Remote job distribution, with an average salary of $118,493 per year, or $57 per hour.

Vice President of Regulatory Affairs

Mohr Talent

Huntington Beach, CA • On-site

$260 - $300/hr

Other

Posted 4 days ago

Job description

Vice President of Regulatory Affairs

Huntington Beach, California Direct Hire $260000 /


Job Description
Vice President of Regulatory Affairs

A patient-focused biotechnology organization is hiring a senior regulatory executive to provide enterprise leadership across Regulatory Affairs, Clinical Operations and Medical Affairs.


This role is ideal for an experienced biotechnology leader who has successfully guided complex regulatory submissions, worked directly with the FDA, and overseen clinical development and Medical Affairs programs. The position offers significant executive visibility and the opportunity to shape the future of an established oncology and cellular immunotherapy platform.


Actual worksite: Seal Beach, California 90740. This position requires onsite presence.


Key Responsibilities

  • Set global regulatory strategy for commercial products, clinical programs, manufacturing changes and future pipeline initiatives

  • Lead IND, BLA, amendment, supplement and post-approval submission activities

  • Represent the organization in FDA meetings, health authority interactions, inspections and regulatory responses

  • Oversee clinical trial execution, CROs, vendors, budgets, timelines, enrollment and operational risk

  • Guide Medical Affairs strategy, scientific publications, advisory boards, KOL relationships and medical education

  • Support investigator-sponsored studies, real-world evidence and post-marketing clinical programs

  • Ensure compliance with FDA requirements, GCP, ICH, GMP and applicable global regulations

  • Advise executive leadership on regulatory, clinical and medical risks and opportunities

  • Establish departmental objectives, budgets, KPIs and long-term organizational plans

  • Recruit, develop and lead high-performing regulatory and clinical teams


Required Background

  • MS, PharmD, PhD, MD or equivalent advanced scientific degree

  • 15+ years in biotechnology, pharmaceuticals or biopharmaceuticals

  • 10+ years of Regulatory Affairs leadership

  • Successful IND and BLA submission leadership

  • Direct FDA and health authority meeting experience

  • Significant Clinical Operations and clinical trial oversight experience

  • Medical Affairs, scientific communications and KOL engagement experience

  • Product development, approval, commercialization and lifecycle management experience

  • Oncology, immunotherapy, cell therapy, cellular therapy or biologics experience preferred

  • Experience managing multidisciplinary teams, CROs, vendors and consultants

  • Willngness to work onsite in Seal Beach, California

  • Availability for up to 30% domestic and international travel


Opportunity Highlights

  • Commercial-stage biotechnology organization

  • Established FDA-approved cellular immunotherapy platform

  • Executive ownership across Regulatory Affairs, Clinical Operations and Medical Affairs

  • Direct interaction with senior leadership and board members

  • Meaningful influence over commercial and pipeline strategy

  • Executive bonus opportunity and relocation assistance


MOHR Talent is an equal-opportunity employer and complies with all applicable federal, state, and local nondiscrimination laws. We provide equal employment opportunities regardless of race, color, religion, sex, national origin, age, disability, marital status, sexual orientation, gender identity, genetic information, military/veteran status, or any other protected status. If you believe you have been discriminated against or have concerns about our compliance, please contact our Human Resources department at hr@themohrgrp.com


Vice President of Regulatory Affairs

Huntington Beach, CA | $260,000–$300,000 Base + 30%+ Target Bonus + Benefits + Relocation Assistance


A patient-focused biotechnology organization is hiring a senior regulatory executive to provide enterprise leadership across Regulatory Affairs, Clinical Operations and Medical Affairs.


This role is ideal for an experienced biotechnology leader who has successfully guided complex regulatory submissions, worked directly with the FDA, and overseen clinical development and Medical Affairs programs. The position offers significant executive visibility and the opportunity to shape the future of an established oncology and cellular immunotherapy platform.


Actual worksite: Seal Beach, California 90740. This position requires onsite presence.


Key Responsibilities

  • Set global regulatory strategy for commercial products, clinical programs, manufacturing changes and future pipeline initiatives

  • Lead IND, BLA, amendment, supplement and post-approval submission activities

  • Represent the organization in FDA meetings, health authority interactions, inspections and regulatory responses

  • Oversee clinical trial execution, CROs, vendors, budgets, timelines, enrollment and operational risk

  • Guide Medical Affairs strategy, scientific publications, advisory boards, KOL relationships and medical education

  • Support investigator-sponsored studies, real-world evidence and post-marketing clinical programs

  • Ensure compliance with FDA requirements, GCP, ICH, GMP and applicable global regulations

  • Advise executive leadership on regulatory, clinical and medical risks and opportunities

  • Establish departmental objectives, budgets, KPIs and long-term organizational plans

  • Recruit, develop and lead high-performing regulatory and clinical teams


Required Background

  • MS, PharmD, PhD, MD or equivalent advanced scientific degree

  • 15+ years in biotechnology, pharmaceuticals or biopharmaceuticals

  • 10+ years of Regulatory Affairs leadership

  • Successful IND and BLA submission leadership

  • Direct FDA and health authority meeting experience

  • Significant Clinical Operations and clinical trial oversight experience

  • Medical Affairs, scientific communications and KOL engagement experience

  • Product development, approval, commercialization and lifecycle management experience

  • Oncology, immunotherapy, cell therapy, cellular therapy or biologics experience preferred

  • Experience managing multidisciplinary teams, CROs, vendors and consultants

  • Willngness to work onsite in Seal Beach, California

  • Availability for up to 30% domestic and international travel


Opportunity Highlights

  • Commercial-stage biotechnology organization

  • Established FDA-approved cellular immunotherapy platform

  • Executive ownership across Regulatory Affairs, Clinical Operations and Medical Affairs

  • Direct interaction with senior leadership and board members

  • Meaningful influence over commercial and pipeline strategy

  • Executive bonus opportunity and relocation assistance


MOHR Talent is an equal-opportunity employer and complies with all applicable federal, state, and local nondiscrimination laws. We provide equal employment opportunities regardless of race, color, religion, sex, national origin, age, disability, marital status, sexual orientation, gender identity, genetic information, military/veteran status, or any other protected status. If you believe you have been discriminated against or have concerns about our compliance, please contact our Human Resources department at hr@themohrgrp.com



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Job Summary

Published: 7/30/2026


Type: Direct Hire


Location: Huntington Beach, California


Category: Medical Wellness


At MOHR Talent, your progress is our passion. We are a national, minority-owned firm committed to empowering diverse talent. Our team provides personalized, growth-driven solutions whether you are looking for a new career move or eager to drive your enterprise further.


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