Associate Director, Regulatory Affairs CMC

Iovance Biotherapeutics, Inc.

Associate Director in Regulatory Affairs managing CMC documentation and regulatory submissions for Iovance Biotherapeutics' cell therapy products. Collaborating with cross-functional teams to ensure compliance and quality standards.

Posted 5/8/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $170,000 - $195,000 per yearWebsite

Tech Stack

Tools & technologies

Google Cloud PlatformVault

About the role

Key responsibilities & impact

Works closely with functional leaders to 1) create the optimal development path for Iovance product candidates, 2) negotiate optimal development paths within internal cross-functional teams and with health authorities, 3) execute clinical-regulatory development plans on-time and while managing all identified risks.
Collaborates with RA CMC Product Lead to execute CMC Submission and Authoring strategy for assigned project.
Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy.
Ensures that evolving global regulations, guidelines and health authority expectations, especially those related to cell therapies, are incorporated into program decision making.
Ensures writing activities meet quality standards and expectations and adhere to applicable Corporate SOPs, policies, guidelines, and regulation.
Assures that standardized practices are implemented and maintained across regulatory documents.
Collaborates with Regulatory Operations to ensure timely and accurate submissions
Critically review source documents for consistency, completeness, and quality.
Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics
Perform miscellaneous duties as assigned.

Requirements

What you’ll need

Minimum of a BA/BS in Life Science
5-8 years pharmaceutical/biotechnology experience related to analytical/pharmaceutical chemistry and/or regulatory affairs.
Demonstrated expertise in writing/developing CMC content in Briefing Documents, Quality Amendments, Module 2 and Module 3 updates and CMC source documents in support of US and global regulatory submissions (with primary interest in the areas of Biologic and Cell Therapy Products).
Understanding of biological lifecycle drug development
Experience with ICH, CTD and electronic submission guidelines for regulatory reports.
Excellent written and verbal skills
Ability to collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization
Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook); experience with electronic document management systems and other content authoring technologies (e.g. Veeva Vault)
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Proven track record with project management and experience with GDP, GCP, and GMP. Ability to handle multiple projects simultaneously.
Excellent attention to accuracy and detail.
Create and maintain core dossier and CMC Authoring templates

Benefits

Comp & perks

🌐 Worldwide ❌ Jobs You've Hidden ⭐️ Saved Jobs ✅ Applied Jobs ✉️ Email Alerts 👤 Account Iovance Biotherapeutics, Inc. Website LinkedIn All Job Openings 501 - 1000 employees Founded 2014 🧬 Biotechnology 💊 Pharmaceuticals ⚕️ Healthcare Insurance Biotechnology
Pharmaceuticals
Healthcare Insurance Iovance Biotherapeutics, Inc. is pioneering a transformational approach to treating cancer by harnessing the human immune system's ability to recognize and attack diverse cancer cells in each patient. The company focuses on T-cell-based immunotherapy, specifically Tumor Infiltrating Lymphocyte (TIL) therapy, which involves reinvigorating a patient’s TILs to fight cancer. Iovance's TIL therapy is being investigated in clinical trials across multiple advanced solid tumor cancers. Additionally, the company is advancing genetically modified TIL therapies and exploring potential applications of PBL (peripheral blood lymphocyte) therapy for blood cancers. As a leader in cell therapy, Iovance owns a state-of-the-art Cell Therapy Center in Philadelphia for manufacturing their therapies using proprietary GMP. The company is at the forefront of developing personalized and patient-specific cancer treatments. Associate Director, Regulatory Affairs CMC Job not on LinkedIn 🔥 4 minutes ago 🇺🇸 United States – Remote 💵 $170k - $195k / year ⏰ Full Time 🟠 Senior 🚔 Compliance Apply Now Find Hiring Managers Customize resume + cover letter Report problem ☆ Save ☑️ Mark as applied ❌ Hide 📋 Description
Works closely with functional leaders to 1) create the optimal development path for Iovance product candidates, 2) negotiate optimal development paths within internal cross-functional teams and with health authorities, 3) execute clinical-regulatory development plans on-time and while managing all identified risks.
Collaborates with RA CMC Product Lead to execute CMC Submission and Authoring strategy for assigned project.
Ensures that submission documents and correspondence are of the highest quality in terms of content, organization, clarity of writing, and accuracy.
Ensures that evolving global regulations, guidelines and health authority expectations, especially those related to cell therapies, are incorporated into program decision making.
Ensures writing activities meet quality standards and expectations and adhere to applicable Corporate SOPs, policies, guidelines, and regulation.
Assures that standardized practices are implemented and maintained across regulatory documents.
Collaborates with Regulatory Operations to ensure timely and accurate submissions
Critically review source documents for consistency, completeness, and quality.
Must adhere to Iovance Biotherapeutics’ core values, policies, procedures, and business ethics
Perform miscellaneous duties as assigned. 🎯 Requirements
Minimum of a BA/BS in Life Science
5-8 years pharmaceutical/biotechnology experience related to analytical/pharmaceutical chemistry and/or regulatory affairs.
Demonstrated expertise in writing/developing CMC content in Briefing Documents, Quality Amendments, Module 2 and Module 3 updates and CMC source documents in support of US and global regulatory submissions (with primary interest in the areas of Biologic and Cell Therapy Products).
Understanding of biological lifecycle drug development
Experience with ICH, CTD and electronic submission guidelines for regulatory reports.
Excellent written and verbal skills
Ability to collaborate with a wide variety of internal customers and relate effectively to people at all levels of the organization
Excellent computer skills including MS Office (Word, Excel, Power Point, Outlook); experience with electronic document management systems and other content authoring technologies (e.g. Veeva Vault)
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Proven track record with project management and experience with GDP, GCP, and GMP. Ability to handle multiple projects simultaneously.
Excellent attention to accuracy and detail.
Create and maintain core dossier and CMC Authoring templates Apply Now 📊 Check your resume score for this job Improve your chances of getting an interview by checking your resume score before you apply. Check Resume Score Similar Jobs Senior GRC Engineer 🔥 17 minutes ago Flock Safety 501 - 1000 🔐 Security Website LinkedIn All Job Openings Senior GRC Engineer developing systems and frameworks to automate compliance in a safety tech company. Collaborating across departments to streamline governance, risk, and compliance processes. 🇺🇸 United States – Remote 💵 $130k - $150k / year 💰 $150M Series E on 2022-02 ⏰ Full Time 🟠 Senior 🚔 Compliance 🦅 H1B Visa Sponsor Senior Manager, Contract Compliance, Value Realization 🔥 1 hour ago Danaher Corporation 10,000+ employees 🧬 Biotechnology 🔬 Science 🤝 B2B Website LinkedIn All Job Openings Senior Manager leading post-sale contract compliance and revenue optimization at Beckman Coulter Diagnostics. Collaborating cross-functionally to enhance contract structures and drive compliance and recovery initiatives. 🇺🇸 United States – Remote 💵 $170k - $195k / year ⏰ Full Time 🟠 Senior 🚔 Compliance 🦅 H1B Visa Sponsor Manager, Global Regulatory Affairs – CMC 🔥 2 hours ago Telix Pharmaceuticals Limited 501 - 1000 🧬 Biotechnology 💊 Pharmaceuticals ⚕️ Healthcare Insurance Website LinkedIn All Job Openings Manager in Global Regulatory Affairs at Telix Pharmaceuticals focusing on CMC submissions and cross-functional collaboration with regulatory teams. 🇺🇸 United States – Remote ⏰ Full Time 🟠 Senior 🔴 Lead 🚔 Compliance Regulatory Labeling Manager – NA, LATAM 🔥 2 hours ago Syneos Health 10,000+ employees 🧬 Biotechnology 💊 Pharmaceuticals ⚕️ Healthcare Insurance Website LinkedIn All Job Openings Regulatory Labeling Manager responsible for leading labeling updates and ensuring compliance with regulations in North America and LATAM. Collaborating with teams for document management and approvals. 🇺🇸 United States – Remote ⏰ Full Time 🟡 Mid-level 🟠 Senior 🚔 Compliance 🦅 H1B Visa Sponsor Employee Screening & Compliance Specialist 🔥 3 hours ago WM 10,000+ employees 📋 Compliance Website LinkedIn All Job Openings Compliance expert managing Drug and Alcohol Testing Programs for WM. Supporting quarterly data analysis and ensuring adherence to DOT requirements. 🇺🇸 United States – Remote 💵 $62.2k - $82.2k / year 💰 Post-IPO Debt on 2023-07 ⏰ Full Time 🟡 Mid-level 🟠 Senior 🚔 Compliance 🦅 H1B Visa Sponsor View More Compliance Jobs 🌐 Worldwide Built by Lior Neu-ner. I'd love to hear your feedback — Get in touch via DM or support@remoterocketship.com Search Search Jobs by country Search jobs by city Search jobs by job title Search entry-level jobs Search junior-level jobs Search senior-level jobs Search jobs by tech stack Search jobs by contract type Search remote internships Search remote part-time jobs Remote jobs Anywhere in the World Companies Hiring Anywhere in the World Companies Hiring Sales People Anywhere in the World Companies Hiring Software Engineers Anywhere in the World Resources Advice Tips for finding remote jobs Interview questions and answers Resume examples Cover letter examples Post a job Affiliates Privacy policy Terms of service Job board SEO course AI Apply Copilot OpenClaw job finder Jobs by Country Remote jobs anywhere in the world (Worldwide remote jobs) Remote jobs United States Remote jobs Australia Remote jobs Brazil Remote jobs Canada Remote jobs France Remote jobs Ireland Remote jobs Germany Remote jobs Netherlands Remote jobs Spain Remote jobs UK Popular Jobs Remote data analyst jobs Remote customer support jobs Remote executive assistant jobs Remote marketing jobs Remote product designer jobs Remote product manager jobs Remote project manager jobs Remote recruiter jobs Remote sales jobs Remote software engineer jobs Jobs by Type Remote full-time jobs Remote part-time jobs Remote contract jobs Remote internship jobs Remote entry-level jobs Remote jobs with no experience required Remote junior jobs (1-3 years of experience) Digital nomad jobs Remote jobs with no degree required Freelance remote jobs Temporary remote jobs Remote jobs hiring now Stay at home mom jobs

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Hard Skills & Tools

CMC content writinganalytical chemistrypharmaceutical chemistryregulatory affairsbiological lifecycle drug developmentICH guidelinesCTD guidelinesGMPGCPGDP

Soft Skills

excellent written skillsexcellent verbal skillscollaborationproblem-solvingattention to accuracyadaptabilityproject managementorganizational skillsinterpersonal skillscommunication