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Regulatory Affairs Cmc Remote Jobs (NOW HIRING)

BrainChild Bio

Director, Regulatory Affairs, CMC

$153K - $202K/yr

BrainChild Bio is seeking a Director, Regulatory Affairs, CMC , to support implementation of the global regulatory CMC strategy across our clinical-stage cell therapy programs. BrainChild Bio is a ...

Recursion

Director, CMC Regulatory Affairs

New York, NY · Remote

$207K - $255K/yr

The Team You'll Join As Director CMC Regulatory Affairs, you will be an essential member of the ... This role is remote-friendly, with most work conducted from home. There may be occasional ...

BeiGene, Inc.

Executive Director, Regulatory Affairs, CMC

$153K - $202K/yr

Biologics Regulatory CMC organization. This role provides strategic and operational leadership for U.S.-based biologics Regulatory CMC activities and serves as a key partner to the China-based ...

Vaxcyte

Sr. Manager, Regulatory Affairs

San Carlos, CA · On-site +1

$183K - $194K/yr

Executive Director, Regulatory CMC Location: US - Remote Work Arrangement (may be adjusted based on business needs, job responsibilities, or changes to company policy): Remote Compensation: The ...

Altimmune

CMC Director, Regulatory Affairs

Morristown, NJ · Remote

$153K - $202K/yr

This position reports to the Head of Regulatory Affairs.Essential Functions:Responsible for high-quality CMC regulatory submissions in support of approval of global marketing and clinical trial ...

Watton Hall

CMC Specialist

CMC Specialist The CMC Specialist in Regulatory Affairs is responsible for overseeing the Chemistry ... Remote working opportunity * Competitive salary, bonus and other benefits * Opportunity for ...

Vaxcyte

Associate Director, Regulatory CMC

San Carlos, CA · On-site +1

$180K - $210K/yr

Biology, Chemistry, Pharmacy, Regulatory Affairs for Drugs, Biologics or Medical Devices). Minimum ... Remote Compensation: The compensation package will be competitive and includes comprehensive ...

Travere

Director, Regulatory Affairs Strategy

San Diego, CA · On-site +1

$159K - $210K/yr

San Diego, USA- Remote Be a part of a global team that is inspired to make a difference in the ... Collaborate with Clinical, Medical, CMC, Nonclinical, and Commercial teams to integrate regulatory ...

Revolution Medicines

Director, Global CMC Regulatory

$153K - $202K/yr

Partner with Regulatory Affairs, technical SMEs, and CROs to ensure alignment of global submission strategies while addressing region-specific CMC requirements and serve as the CMC regulatory ...

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How much do regulatory affairs cmc remote jobs pay per hour?

As of Aug 14, 2026, the average hourly pay for regulatory affairs cmc remote in the United States is $39.57, according to ZipRecruiter salary data. Most workers in this role earn between $31.73 and $46.88 per hour, depending on experience, location, and employer.

What is a regulatory affairs CMC remote job?

Regulatory Affairs CMC (Chemistry, Manufacturing, and Controls) remote jobs involve managing and overseeing the regulatory compliance aspects of pharmaceutical product development and manufacturing, specifically focusing on CMC documentation and submissions. Professionals in these roles ensure that all CMC-related materials meet the requirements of regulatory agencies such as the FDA or EMA, even while working remotely. They collaborate with cross-functional teams to prepare, review, and submit necessary documents for drug approvals, amendments, and renewals. Remote positions allow these professionals to perform their duties from any location, using digital tools to communicate and submit documentation securely.

What skills and qualifications are needed to thrive as a regulatory affairs CMC professional in a remote role?

To thrive as a Regulatory Affairs CMC Remote professional, you need a deep understanding of regulatory guidelines, CMC documentation, and pharmaceutical development processes, often supported by a science degree and relevant experience. Familiarity with electronic submission systems like eCTD, regulatory databases, and knowledge of global regulations (FDA, EMA, ICH) are essential. Strong project management, attention to detail, and effective communication skills are crucial for collaborating with cross-functional teams and ensuring regulatory compliance. These abilities ensure accurate and timely submissions, maintain product quality, and facilitate successful market approvals in a virtual work environment.

What are common challenges faced by regulatory affairs CMC professionals working remotely, and how can they be addressed?

Remote Regulatory Affairs CMC professionals often face challenges such as coordinating effectively with cross-functional teams and ensuring timely access to up-to-date documentation. Communication can be more complex when collaborating with global stakeholders across time zones. To address these challenges, it’s important to establish clear protocols for document sharing, utilize collaborative project management tools, and schedule regular virtual meetings to maintain alignment. Building strong relationships with colleagues and proactively seeking updates can also help ensure smooth regulatory submissions and compliance.
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Regulatory Affairs Cmc Remote jobs near you
Infographic showing various Regulatory Affairs Cmc Remote job openings in the United States as of August 2026, with employment types broken down into 50% Full Time, and 50% Part Time. Highlights an 100% Remote job distribution, with an average salary of $82,307 per year, or $39.6 per hour.

Director, Regulatory Affairs, CMC

BrainChild Bio

Remote

$153K - $202K/yr

Full-time

Re-posted yesterday

Job description

BrainChild Bio is seeking a Director, Regulatory Affairs, CMC, to support implementation of the global regulatory CMC strategy across our clinical-stage cell therapy programs. BrainChild Bio is a kids-first company focused on developing innovative cell therapies for patients with devastating diseases, and this role plays a critical part in ensuring that every product delivered meets the highest standards of quality, safety, and reliability.
The Director, Regulatory Affairs, CMC is accountable for executing on the global CMC regulatory strategies across multiple products. This role contributes to the planning, preparation, and submission of regulatory CMC documentation. The individual will be expected to provide guidance to the program teams and will be responsible for preparation of CMC and Quality related agency correspondences and regulatory applications ensuring all applicable regulatory requirements are considered and appropriately incorporated into the lifecycle of each program.
The ideal candidate is detail-oriented, highly organized, and motivated by the opportunity to make a direct impact on patients' lives. This role offers the opportunity to work cross-functionally with development teams, and with relevant external parties including contract manufacturing organizations, expert consultants, and global health authorities.
Responsibilities:
  • Lead all operational and lifecycle management aspects of Regulatory CMC submissions (e.g., INDs, IMPDs, BLAs, MAAs, variations, amendments) supporting cell therapy development programs.
  • Develop and execute global regulatory CMC strategies that align with program objectives, regulatory requirements, and overall business strategy.
  • Serve as the Regulatory CMC lead on cross-functional program teams, providing strategic regulatory guidance for cell therapy development and lifecycle management.
  • Author, review, and coordinate Module 3 (M3) content, ensuring consistency, quality, and alignment across global regulatory submissions (e.g., US, EU, and other international health authorities).
  • Evaluate the regulatory impact of CMC changes through formal change control processes and define and execute appropriate filing strategies.
  • Proactively identify CMC regulatory risks, anticipate Health Authority questions, and develop of mitigation and contingency strategies to support successful outcomes.
  • Lead or contribute to interactions with health authorities by preparing briefing packages, technical justifications, responses to information requests, and regulatory meeting support.
  • Collaborate cross-functionally to ensure CMC deliverables meet regulatory requirements, quality standards, and program timelines.
  • Drive continuous improvement and best-practice sharing for Regulatory CMC processes in a rapidly growing, dynamic environment.

Qualifications:
  • Bachelor's degree in scientific discipline (e.g., Chemistry, Biochemistry, Biology, Chemical Engineering, or related field).
  • 8+ years of Regulatory CMC and/or drug development experience, including direct experience supporting FDA-regulated cell therapy products.
  • Familiarity with GMP principles and documentation practices.
  • Strong attention to detail, organizational skills, and ability to manage multiple priorities.
  • Effective communication skills and ability to work cross-functionally.
  • Ability to thrive in a fast-paced, mission-driven, small company environment and adapt to shifting priorities.
  • Occasional travel required.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.

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