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Regulatory Affairs Cmc Remote Jobs (NOW HIRING)

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Director, Regulatory Affairs - CMC/Biologics

Blue Bell, PA · Remote

$143K - $189K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

Director, Regulatory Affairs CMC Location The position may be remote based across the US, or East Coast preferred The Role As a Director in CMC Regulatory Affairs, you will provide expert knowledge ...

New

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 ...

BeiGene, Inc.

Intern - Regulatory Affairs, CMC (year-round)

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The Regulatory Affairs CMC Intern will support regulatory projects consistent with company goals by working closely with the hiring manager and cross-functional team members, including Quality ...

BeiGene USA

Intern - Regulatory Affairs, CMC (year-round)

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

The Regulatory Affairs CMC Intern will support regulatory projects consistent with company goals by working closely with the hiring manager and cross-functional team members, including Quality ...

Otsuka

Senior Manager, CMC Global Regulatory Affairs

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

Job Summary The Chemistry, Manufacturing and Controls (CMC) Global Regulatory Affairs (GRA) professional is responsible for developing and executing global regulatory strategies for CMC aspects of ...

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 USA

Executive Director, Regulatory Affairs, CMC

$153K - $202K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

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 ...

BeiGene, Inc.

Executive Director, Regulatory Affairs, CMC

$153K - $202K/yr

  • Medical

  • Dental

  • Vision

  • Life

  • Retirement

  • PTO

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 ...

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

As of Aug 16, 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/Biologics

410 ICR United States USA

Raleigh, NC • Remote

$145K - $192K/yr

Full-time

Medical, Dental, Vision, Life, Retirement

Posted 2 days ago

New

Job description

Director, Regulatory Affairs - CMC/Biologics

ICON is a global healthcare intelligence and clinical research organisation united by a mission to bring new medicines and treatments to patients faster.


As a values-driven organisation, integrity, collaboration, agility, and inclusion are at the heart of how we work and interact with each other, customers, patients and suppliers.


Director, Regulatory Affairs CMC

Location

The position may be remote based across the US, or East Coast preferred

The Role

As a Director in CMC Regulatory Affairs, you will provide expert knowledge on exciting area of small and large molecules within the Global Regulatory Affairs, CMC team which forms part of our Regulatory Consulting Services Group.

The department is growing and there are excellent prospects for professional development and enhancing your skills. With a variety of new projects, we are looking to enhance the knowledge within our team with the addition of this hire. Activities encompass early and late stage drug development, marketing application and approval, and product maintenance.

We are seeking individuals with experience in technical development, testing, and manufacturing of small and large molecules (Biologics [mAb, bSAb & Recombinant Protein, RNA, mRNA, SiRNA], Biosimilars, CGT, ADC & Vaccines), Peptides and Radiopharmaceuticals in particular with CMC experience.

Responsibilities

  • Serve as a technical expert in development, testing and manufacturing of Biologics and resource to ICON colleagues, and clients providing advice

  • Effectively manage the preparation of regulatory CMC submission documents for INDs/NDAs/BLAs/NDSs/ANDAs and Post approval supplements

  • Facilitate submission approvals and amendments through leading communications and negotiations with client, government agencies, and project teams.

  • Actively anticipate and develop initial or alternative regulatory strategies, consulting with other resources within the organization as required.

  • Provide clients with strategic advice in response to their queries, based on regulatory experience and area of expertise.

  • Enthusiastically monitors for new regulatory requirements and shares key findings.

  • Lead and/or participate in the preparation of quotations for projects that may cross multiple service areas within the company and manage projects within budget, preparing change orders as needed.

  • Experience in US FDA Drug listing (NDC) process, Drug establishment Registrations, Lot Distribution Reports

  • Serve as US Agent for client submissions and act as interface with local agency and sponsor

  • Support right from preclinical to post approval activities for client submissions.

Education/Experience

  • Bachelors degree in a relevant discipline, preferably in a life sciences, or other healthcare field.

  • Advanced degree (MSc., PhD., M.D., Pharm.D., MBA) in the biological, medical, chemical or engineering field may be beneficial.

  • Relevant experience i.e. pharmaceutical, biologics with regulatory experience in the global environment (e.g. US, EU, Canada).

  • Technical development, testing and manufacturing of wide range of dosage forms

  • Demonstrable experience in a regulatory CMC role or in the delivery of regulatory CMC strategy and documentation during drug development and/or product maintenance.

  • Experience supporting business development activities and people management an asset.

  • Certification in regulatory affairs (RAC) or post-secondary institution beneficial.

#LI-SB4

#LI-Remote


Employment with ICON is contingent upon having the legal right to work in the country where the role is based.


Rewards & Benefits

ICON offers a competitive and comprehensive total rewards package designed to support your health, wellbeing, and career development.


Benefits may include:

  • Competitive base salary and performance related incentives
  • Health and wellbeing programmes including medical, dental, and vision coverage where applicable
  • Retirement and pension plans
  • Life assurance and disability coverage
  • Employee assistance programmes and wellbeing resources
  • Learning and development opportunities through structured training and career pathways

Benefits may vary depending on role and location.


Visit our careers site to read more about the benefits ICON offers.


Inclusion and Accessibility

ICON is an equal opportunity employer. We are committed to building an inclusive and accessible workplace where everyone feels valued and supported.


If you require reasonable accommodations during the recruitment process, please let us know or submit a request here.

Are you a current ICON Employee? Please click here to apply