Director, Global Regulatory Affairs Job Listing at Kelly Services in South San Francisco, CA (Job ID US3534846_BH9727950)

Description

Kelly® Science & Clinical is seeking a Director of Global Rgulatory Affairs for a fulltime, Direct Hire role with a pharmaceutical client based in the San Fran Bay area. If you're passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts.

Position Overview:

The Director, Global Regulatory Affairs is responsible for contributing to the development and execution of regulatory strategies and managing regulatory submissions for our client's products. This role involves collaborating with cross-functional teams to ensure compliance with global regulatory standards and efficient management of regulatory activities throughout the product lifecycle.

 

This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to the Vice President, Global Regulatory Affairs.

 

Key Duties & Responsibilities:

Key responsibilities of this role include, but are not limited to:

• Contribute to the regulatory strategy, development, and execution for company's products, including nonclinical and clinical regulatory strategy, INDs, marketing applications, and post-approval changes.
• Collaborate with internal teams, such as R&D, Corporate Development, Quality Assurance, and Clinical, to ensure alignment of regulatory strategies with product development goals.
• Identify regulatory risks and proactively work with cross-functional teams to develop mitigation strategies.
• Perform critical review and provide strategic input on submission documents to ensure compliance with regulatory requirements, health authority guidance, and company policies.
• Oversee the preparation, review, and submission of regulatory submissions to health authorities.
• Coordinate, prepare, and contribute to the development of document packages for regulatory submissions, including INDs, NDAs, meeting requests, meeting briefing documents, responses to FDA comments and IRs, DSURs/Annual Reports, clinical study protocols, clinical study reports, and application amendments for assigned projects.
• Lead regulatory project timelines, ensuring that deliverables are met in a timely and efficient manner, and resolve issues that may arise during the product lifecycle.
• Act as a primary regulatory point of contact for IND(s) with the U.S. FDA.
• Manage and mentor Regulatory Affairs direct report(s), providing guidance on regulatory issues, career development, and project management.
• Stay up-to-date with evolving global regulations and industry trends, ensuring that the company remains compliant with current standards and best practices.

 

Qualifications:

• Bachelor's degree in Life Sciences, Pharmacy, or related field. Advanced degree (Master's, PhD, or PharmD) is preferred.
• 8-10 years of experience in Regulatory Affairs.
• Proven track record of successful regulatory submissions and approvals in relevant markets.
• Management and mentoring experience preferred.
• In-depth knowledge of regulatory requirements and guidelines (e.g. FDA, ICH).
• Experience with electronic submission systems (e.g. eCTD, SPL).
• Regulatory writing and liaison experience is required.
• Excellent written and verbal communication skills, with the ability to present complex information clearly.
• Strong problem-solving abilities and attention to detail.
• Strong project management and organizational skills.
• Ability to work under pressure and manage competing priorities.

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® Science & Clinical?

Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the world's most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goals—it's the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed.

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 Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kelly's 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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