Senior Regulatory Affairs Consultant Job Listing at Kelly Services in Westlake Village, CA (Job ID US3618642_BH10008070)

Description

Senior Regulatory Affairs Consultant
Location: Remote (U.S.)
Pay Range: $170,000 – $190,000 annually + full benefits (Medical, Dental, PTO, 401k)
Type: Full-Time, Direct Hire
Travel: 20–30% domestic/international

About the Opportunity

Our client is a global regulatory consulting firm serving the biotech, pharmaceutical, and medical device industries. They specialize in supporting the development and market authorization of drug-device combination products and delivery systems.

This position is ideal for a Regulatory Affairs expert who enjoys strategic consulting, complex submissions, and leading client-facing projects in a fast-paced environment.

Position Summary

The Senior Regulatory Affairs Consultant – Combination Products will lead regulatory strategy, authoring, and submission management for combination product and drug delivery system programs. The role requires broad experience with global submissions, regulatory guidance, and cross-functional leadership.

Key Responsibilities

• Manage and author eCTD submissions (NDA, BLA, IND, PMA, 510k, IDE, MAA, CE Mark, NB Opinion, etc.).

• Develop and execute global regulatory strategies for product development and lifecycle management.

• Provide consulting expertise across the full regulatory pathway.

• Mentor junior consultants and coordinate technical collaboration.

• Support creation of internal SOPs, templates, and best practices.

Required Qualifications

• Bachelor's degree in Engineering, Biology, Chemistry, or related scientific discipline.

• 7+ years of Regulatory Affairs experience in combination product or drug delivery systems.

• Strong eCTD authoring and submission management experience.

• Familiarity with DHF documentation, design control, and relevant FDA/EMA regulations.

• Excellent leadership, organizational, and communication skills.

Preferred Qualifications

• Experience with autoinjectors, pre-filled syringes, or wearable delivery systems.

• Prior consulting or sponsor-side regulatory leadership experience.

Additional Details

• Fully remote position with 20–30% domestic/international travel.

• Comprehensive benefits package (Medical, Dental, Vision, PTO, 401(k)).

• Reports to the Director of Regulatory Strategy.

• Opportunity to join a growing, collaborative regulatory team supporting global clients.

As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community.

Why Kelly® Engineering?

Your engineering skills are in demand, but how do you find the right fit? Easy. At Kelly Engineering, our team creates expert talent solutions to solve the world's most critical challenges. We connect you with leading organizations where you can collaborate on innovative projects, work with cutting-edge technologies and accelerate your growth. Whether you prefer the variety and flexibility of short-term projects or are looking for a long-term opportunity, we're here to guide you to the next step in your engineering career.

About Kelly

Work changes everything. And at Kelly, we're obsessed with where it can take you. To us, it's about more than simply accepting your next job opportunity. It's the fuel that powers every next step of your life. It's the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your life—just ask the 300,000 people we employ each year.

Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of California's state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.

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