Associate Director Regulatory Affairs
GrabJobs
Our client, a world leader in biotechnology and life sciences, is seeking a " Senior Program Director, Commercial Regulatory Affairs ". Location: South San Francisco, CA (Fully Remote) Duration: Long -Term Contract (Possibility Of Further Extension) Pay Rate: $120 -$127/hr on W2 Company Benefits: Medical, Dental, Vision, Paid Sick Leave, 401K Job Summary In this role, you will provide strategic regulatory guidance for U.S. commercial pharmaceutical products. You will lead Promotional Review Committees (PRCs), review and approve advertising and promotional materials, and partner closely with Marketing, Medical Affairs, Legal, and Compliance to ensure FDA‑compliant communications. This position offers the opportunity to shape commercial regulatory strategy for innovative therapies in a fast‑paced biotech environment. Key Responsibilities: Lead Promotional Review Committee (PRC) meetings Review and approve promotional and marketing materials Provide regulatory guidance on advertising and promotional claims Partner with Marketing, Medical, Legal, and Compliance teams Support FDA communications and Form 2253 submissions Ensure compliance with FDA regulations and healthcare industry guidelines Qualifications: Bachelor's degree required; advanced degree (PharmD, PhD, JD, MBA, MS) preferred 7+ years of Regulatory Affairs, Commercial Regulatory, Compliance, or Advertising & Promotion experience in the biotech/pharmaceutical industry Strong knowledge of FDA advertising & promotion regulations, promotional review, and healthcare compliance Experience leading cross -functional teams and Promotional Review Committees (PRCs) Excellent communication, stakeholder management, and project leadership skills Preferred Skills: Commercial Regulatory Affairs Advertising & Promotion (Ad/Promo) Promotional Review Committee (PRC) FDA Form 2253 Medical, Legal, Regulatory (MLR) review Product launch support If interested, please share your updated resume at View email address on click.appcast.io / View email address on click.appcast.io
$154.4k - $242.55k
...guidance to teams for the delivery of global regulatory strategies to support development and... ...represent the Global Regulatory Affairs (GRA) function in senior level interactions... ...guidance comments and supporting trade association working groups.Education & Competencies...SuggestedMinimum wageTemporary workLocal areaRemote work$103.6k - $288.6k
Job OverviewLine Management responsibilities for a team of Regulatory staff or may be responsible for the performance of one or more Regulatory Affairs sites. Responsible for the development of regulatory business, in accordance with Global Regulatory Affairs business...SuggestedFull timePart timeWork at officeImmediate startWorldwideFlexible hours$190k - $210k
...making a profound impact, together - for our patients, for your career, and for what’s beyond.About the Role >>>Associate Director, Global Regulatory Affairs, ComplianceAs the Global Associate Director, Regulatory Affairs Compliance, reporting to the Senior Director, Global...SuggestedWork at officeFlexible hours2 days per week- ...propel your career to new heights.Making animals’ lives better makes life better - join our team today!Your RoleAs Associate Director, Regulatory Affairs - Biologics, you will lead regulatory strategy for biologics and vaccine programs supporting Animal Health innovation...SuggestedFull timeSummer workRelocationFlexible hours
$138.75k - $231.25k
Associate Director Regulatory Affairs, OncologyAt GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. R&D is committed to discovering and delivering transformational vaccines and medicines to prevent...SuggestedFull timeLocal area$169k - $242k
Sunnyvale, CA / Washington, DCGeneral & Administration - Regulatory Affairs /Full-Time /RemoteOur mission is to detect cancer early, when... ...companies.For more information, please visit grail.comThe Director/Associate Director, International Regulatory Affairs supports the...16 hoursFull timeLocal areaFlexible hoursShift work$170.9k - $231.3k
OverviewThe Associate Director of Regulatory Affairs Strategy will work on assigned programs with the respective Global Regulatory Portfolio Lead, Global Regulatory Lead and cross-functional team to lead and define the regulatory strategy, facilitate submission of data...Full timeTemporary workLocal areaWorldwideFlexible hours2 days per week$154.4k - $242.55k
...global strategies to maximize global regulatory success towards achievement of program... ...regional counterparts.Accountabilities:The Associate Director will be responsible for complex or... ...understanding broad concepts within regulatory affairs and implications across the...Minimum wageTemporary workLocal areaRemote work$154.4k - $242.55k
...boundaries of what is possible in order to bring life-changing therapies to patients worldwide.This role is within the Global Regulatory Affairs (GRA) Chemistry Manufacturing & Controls (CMC) and Devices organization, and will contribute to the team’s delivery of...Minimum wageTemporary workLocal areaRemote workWorldwide- ...to Work in 2026, ranking No. 15 on the Top 100 list, reflecting the culture our employees experience every day.The Associate Director, Regulatory Affairs - Pulsed Field Ablation (PFA) is responsible for leading global regulatory strategy and execution for Boston Scientific...Hourly payWorldwideShift work
$135.3k - $202.9k
...development and career advancement across the globe.Scope: The Regional Regulatory Lead is responsible for the regulatory strategy and execution... ...degree and at least 5 years of regulatory affairs strategy experience in drug development in the US.Demonstrated...Local areaFlexible hours3 days per week$129.3k - $258.7k
...dilatation catheters, imaging catheters and software, vessel closure devices and peripheral stents.The Opportunity This Associate Director, Regulatory Affairs will work on-site at our Westford, MA location in the Vascular Division. As a manager, the function of an Associate...WorldwideShift work- JOB SUMMARYThe Associate Director/Director of Regulatory Affairs - Chemistry, Manufacturing and Controls (CMC) will lead global CMC regulatory strategy and execution across Iambic's development programs. The role will prepare and oversee high-quality CMC content for regulatory...Work at officeFlexible hours
$148.7k - $297.3k
...States - California - AlamedaJob Type: Full timeCategory: Regulatory AffairsIndustry: HealthcarePosted Date: 2026-07-10... ...female executives, and scientists.The Opportunity This Associate Director Regulatory Affairs will work on-site out of our Alameda, CA location in the...Worldwide$177.4k - $238.96k
...portfolio of early-stage ADCs pursuing undisclosed solid tumor targets.Position OverviewImmunome is seeking an Associate Director / Director, Regulatory Affairs CMC, responsible for developing and executing global regulatory CMC strategies across multiple modalities....Flexible hours$170.9k - $231.3k
## Associate Director, Regulatory Affairs, CMCUnited StatesApply NowFind out how well you match with this jobJob ID3315This role is considered:Hybrid**Overview**The Associate Director, Regulatory Affairs CMC Development is responsible for developing and implementating...Full timeTemporary workWork at officeLocal areaFlexible hoursAlnylam Switzerland GmbH
Cambridge, MA2 days ago$145.6k - $279.4k
...Job Description Summary The Associate Director, Regulatory Affairs – Biosimilars (US) leads U.S. regulatory strategy and execution for biosimilar development and marketed products. The role serves as the U.S. regulatory lead for assigned biosimilar assets, delivering...Work at officeVisa sponsorshipWork visaRelocation packageU023 (FCRS = US023) Sandoz Inc
Princeton, NJ2 days ago$137k - $235.75k
...of our employees and recognize their merit.Job Function: Regulatory Affairs GroupJob Sub Function: Regulatory AffairsJob Category:ProfessionalAll... ...Learn more at We are searching for the best talent for an Associate Director, Regulatory Affairs, North American Regional Leader (NARL)...Full timeLocal areaImmediate startFlexible hours$132k - $193.6k
...best to work that truly matters for patients, we invite you to join us. Organization Overview:The purpose of the Associate Director, Global Regulatory Affairs - Product Communications role is to provide leadership and influence to deliver accurate, balanced, and...Full timeH1bWork at officeVisa sponsorshipWork visaFlexible hours- ...improvements in quality of life and survival for people with cancer. What you'll be doing As a key member of the Nuvation Regulatory Affairs team, you will collaborate with a cross-functional team and global licensing partners to further develop commercial stage...Full timeFor contractorsLocal areaRemote work
Nuvation Bio, Inc.
United States5 days ago - ...Associate Director, Regulatory Affairs -Advertising and Promotional Review Delcath is seeking for a well-rounded FDA regulatory professional with experience or familiarity with promotional and medical material review for approved prescription drugs and/or devices....Work at officeRemote work
Delcath
United States2 days ago $170k - $190k
...re exploring the potential of cutting-edge science as a subsidiary of Nippon Shinyaku Co., Ltd. In Japan Summary: CMC Regulatory Affairs develops and executes CMC regulatory strategies for investigational and marketed products in close collaboration with...Temporary workFor contractorsWork at officeFlexible hoursNS Pharma Inc
Paramus, NJ6 hours ago- ...of differentiated investigational therapeutic candidates for well-validated targets. Reporting to the Senior Director, Regulatory Affairs, the Associate Director, Regulatory Affairs will represent Regulatory Affairs on assigned cross-functional teams and lead day-to...Temporary workWork at officeLocal areaImmediate start3 days per week
Viridian Therapeutics, Inc.
Waltham, MA5 hours ago $175.35k - $219.2k
...About the Job: The Associate Director, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities...Foundation Medicine
Boston, MA4 days ago$150.1k - $225.15k
...Working here means being entrepreneurial, thinking big and working together to make the impossible a reality. The Associate Director Promotional Regulatory Affairs will work with a with a cross-functional review team and provide regulatory guidance and risk assessment to...Temporary workWork at officeFlexible hours3 days per weekJobleads-US
Gaithersburg, MD2 days ago$205k - $225k
...Associate Director, Regulatory Affairs Advertising and Promotion Foster City Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases. We are passionate about advancing scientific discoveries to become important...Work at officeLocal areaMirum Pharmaceuticals
San Mateo, CA5 days ago$170k - $195k
...Associate Director, Regulatory Affairs Remote Parabilis Medicines is a clinical-stage biopharmaceutical company dedicated to creating extraordinary medicines for patients with serious diseases by unlocking biologically important targets long considered undruggable...Work experience placementRemote workShift workParabilis Medicines
United States5 days ago- ...Anagram Therapeutics, Inc. in Natick, MA is seeking an experienced Associate Director to lead Regulatory Affairs CMC across development and lifecycle stages. You will plan submission strategies, prepare CMC documents for INDs/NDAs/BLAs, and collaborate with cross-functional...
Anagram Therapeutics, Inc.
Natick, MA4 days ago - ...Aspen Neuroscience, Inc. in San Diego, CA, is seeking an Associate Director of Regulatory Affairs (CMC) to lead strategic and operational CMC activities for biologics cell therapies and delivery devices from development through lifecycle management. This on-site role...
Socket
San Diego, CA4 days ago $164k - $213k
...patients, for each other, and for the future of science, we're in. Are you? About the Role: We're looking for an Associate Director, Regulatory Affairs on the Regulatory Affairs team to help us expand what's possible for patients with serious diseases. Reporting to...Local areaRemote workFlexible hoursInsmed Incorporated
United States4 days ago
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