Director of Global Regulatory Affairs, Pharma Job Listing at Kelly Services in Foster City, CA (Job ID US3556173_BH9795175)

Description

Kelly® Science & Clinical is seeking a Director of Regulatory Affairs for a fulltime, Direct Hire role with a pharmaceutical client based in 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.

Base Salary Starting at: $190,000

Location: San Francisco Bay Area (Hybrid)

Schedule: M-F 8AM - 5PM

 

Job Title: Global Regulatory Affairs Director

 

Position Overview: The Global Regulatory Affairs Director will play a pivotal role in leading and managing our global regulatory strategy to ensure the successful approval and commercialization of our promising HBV small molecule drug. This position requires a seasoned regulatory expert who can navigate complex international regulations and manage relationships with regulatory authorities worldwide.

 

Key Responsibilities:

• Develop and implement robust global regulatory strategies
• Lead the preparation, submission, and maintenance of regulatory filings and correspondence with regulatory agencies (e.g., FDA, EMA).
• Ensure compliance with all relevant regulations and guidelines throughout the drug development process.
• Provide strategic direction and guidance on regulatory requirements to internal teams, including clinical, manufacturing, and marketing.
• Monitor changes in the regulatory landscape and assess their impact on ongoing and future drug development activities.
• Act as the primary point of contact between the company and global regulatory authorities.
• Manage regulatory risks and develop risk mitigation strategies to ensure timely submissions and approvals.
• Up to 10% travel to industry meetings and conferences

 

Qualifications:

• BS/MS/PhD in Life Sciences, Pharmacology, Pharmacy, or a related degree
• Minimum of 10 years of experience in U.S. regulatory affairs, specifically within the pharmaceutical industry. Global experience is a plus.
• Proven track record of successfully leading regulatory strategy and submissions for small molecule drugs.
• Experience working with the FDA and filing NDAs.
• In-depth knowledge infectious disease related therapeutic areas is a plus.
• Excellent communication and interpersonal skills, with the ability to engage and negotiate with regulatory authorities.

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 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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