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Pharmaceutical Development Cmc Leader information

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$89K

$191.4K

$287.5K

How much do pharmaceutical development cmc leader jobs pay per year?

As of Sep 15, 2026, the average yearly pay for pharmaceutical development cmc leader in the United States is $191,412.00, according to ZipRecruiter salary data. Most workers in this role earn between $94,000.00 and $249,000.00 per year, depending on experience, location, and employer.

What is a pharmaceutical development CMC leader?

Pharmaceutical Development CMC (Chemistry, Manufacturing, and Controls) Leaders are professionals responsible for overseeing the development and implementation of strategies related to the chemistry, manufacturing, and quality control aspects of pharmaceutical products. They ensure that drug candidates are developed in compliance with regulatory standards and are manufacturable at scale. Their role involves coordinating cross-functional teams, managing timelines, and ensuring successful submission of CMC sections for regulatory filings. CMC Leaders play a critical role in bridging the gap between drug discovery and commercial manufacturing, helping to bring new therapies to market efficiently and safely.

What are the key skills and qualifications needed to thrive as a pharmaceutical development CMC leader?

To thrive as a Pharmaceutical Development CMC Leader, you need expertise in chemistry, manufacturing, and controls (CMC), pharmaceutical sciences, and regulatory requirements, typically supported by an advanced degree in a relevant field. Familiarity with regulatory submission systems, project management tools, and quality assurance frameworks is essential. Strong leadership, cross-functional collaboration, and strategic communication skills set outstanding candidates apart. These capabilities are crucial for ensuring compliant, efficient drug development processes and successful product approvals.

What are some typical cross-functional collaborations that a pharmaceutical development CMC leader is involved in during drug development projects?

Pharmaceutical Development CMC Leaders frequently collaborate with teams across regulatory affairs, clinical development, quality assurance, and manufacturing. They play a central role in ensuring that Chemistry, Manufacturing, and Controls (CMC) strategies are aligned with overall project timelines and regulatory requirements. This position often involves leading multidisciplinary meetings, coordinating with external partners such as contract manufacturing organizations (CMOs), and ensuring smooth communication among scientific, operational, and regulatory teams to facilitate successful product development and commercialization.

What are popular job titles related to Pharmaceutical Development Cmc Leader jobs?

For Pharmaceutical Development Cmc Leader jobs, the most frequently searched job titles are:

Assistant Director / Associate Director, Pharmaceutical Development ‒ Regulatory Writing

Carlsbad, CA • On-site

Ionis
See more jobs at Ionisexternal

Full-time

Re-posted 16 days ago

Job description

Headquartered in Carlsbad, California, and with offices in Boston, Massachusetts, and Dublin, Ireland, Ionis has been at work for more than three decades discovering medical breakthroughs that have redefined life for people with serious diseases. We're pioneers in RNA-targeted medicines, and our platform continues to revolutionize drug discovery and transform lives for patients with unmet needs. With multiple marketed medicines and a leading pipeline in neurology, cardiology and select areas of high patient needs, we continue to drive innovation in RNA therapies in addition to advancing new approaches in gene editing to provide greater value to patients and are well positioned financially to deliver on our strategic goals.
At Ionis, we pride ourselves on cultivating a challenging, motivating and rewarding environment that fosters innovation and scientific excellence. We know that our success is a direct result of the exceptional talents and dedication of our employees.
With an unprecedented opportunity to change the course of human health, we look to add diverse individuals, skill sets and perspectives to our exceptional team. We continue to invest time, money and energy into making our onsite, hybrid and remote work environments a place where solid and lasting relationships are built and where our culture and employees can thrive.
We're building on our rich history, and we believe our greatest achievements are ahead of us. If you're passionate about the opportunity to have meaningful impact on patients in need, we invite you to apply and join us. Experience and contribute to our unique culture while you develop and expand your career!
Assistant Director / Associate Director, Pharmaceutical Development - Regulatory Writing
SUMMARY:
Ionis Pharmaceuticals is seeking an experienced Pharmaceutical Development professional with a primary focus on preparation of CMC documents in support of development and late-stage drug product programs. This role is well-suited for an individual who can independently author, coordinate, and defend high-quality CMC content for global regulatory submissions and internal reports, while partnering closely with Pharmaceutical Development, Analytical, Quality, Regulatory CMC, Clinical Supply, Device, Project Management, and external stakeholders.
The ideal candidate will bring strong technical expertise in drug product development, along with excellent scientific writing, cross-functional coordination, and document management skills. This position will focus primarily on dossier and report authoring, with occasional support for routine laboratory execution or other departmental activities as needed. The ability to interpret development, manufacturing, analytical, and stability data with scientific rigor and sound judgment is essential.
The successful candidate will drive progress by synthesizing complex technical information quickly to produce polished regulatory documents that accurately communicate the technical information with strategic clarity. They will proactively elevate the quality and efficiency of CMC authoring across Pharmaceutical Development programs to ensure submissions are accurate, complete, and on time.
RESPONSIBILITIES:
  • Serve as the primary author and / or coordinator for drug product CMC sections of regulatory submissions and supporting documents, including INDs, IMPDs, NDAs, briefing packages, and responses to regulatory questions.
  • Translate technical data from formulation development, drug product / device development and manufacturing, analytical testing, stability studies, specifications, and control strategies into clear, accurate, phase-appropriate regulatory narratives and summaries.
  • Partner with Pharmaceutical Development leads and cross-functional CMC teams to define authoring strategy, align messaging across drug product sections, identify data gaps early, and drive document completion within aggressive timelines.
  • Lead document planning, content integration, version control, review cycles, comment reconciliation, and finalization of submission-ready CMC documents.
  • Author and/or review related technical documents that support regulatory filings, such as development reports, justification documents, protocols, specifications, batch records, stability summaries, and change assessments.
  • Develop and standardize templates, best practices, and authoring workflows that improve consistency, efficiency, and quality across multiple concurrent programs.
  • Contribute strategically to late-stage and commercial readiness activities by helping shape regulatory content for lifecycle changes, platform justifications, comparability arguments, and global expansion efforts.
  • Communicate effectively with internal stakeholders, external partners, and vendors to obtain data, resolve issues, and keep submission activities moving forward.
  • Support process development of drug product manufacturing and formulation development for early stage and late-stage drug products as needed.

REQUIREMENTS:
  • BA/BS or higher degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, Biochemistry, or a related scientific discipline with a minimum of 8 years (BA/BS), 6 years (MA/MS), or 3 years (PhD) drug product development experience is preferred.
  • Experience in sterile drug product development and manufacture with responsibility authoring CMC content for regulatory submissions.
  • Ability to write clearly, accurately, and persuasively for regulatory audiences while maintaining scientific rigor and presentation clarity.
  • Experience authoring technical and administrative CMC documents and working within controlled documentation systems.
  • Good judgment in interpreting data, identifying risks or inconsistencies, and facilitating practical resolutions to support submission quality and timelines.
  • Knowledgeable in FDA, ICH, USP, ISO and other relevant regulatory guidance applicable to pharmaceutical development and CMC submissions.
  • Competent in common laboratory practices relevant to drug product formulation and development.
  • Excellent organizational, project management, and communication skills, with the ability to manage multiple time-sensitive deliverables independently.

Please visit our website, http://www.ionis.com for more information about Ionis and to apply for this position; reference requisition # IONIS004082
Ionis offers an excellent benefits package! Follow this link for more details: Ionis Benefits
Full Benefits Link: https://ionis.com/careers#:~:text=Highly%20competitive%20benefits
The pay scale for this position is $93,200 to $186,749
The pay scale for the Assistant Director position is $93,200 to $186,749
The pay scale for the Associate Director position is $156,216 to $190,120
NO PHONE CALLS PLEASE. PRINCIPALS ONLY.
Ionis Pharmaceuticals, Inc. and all its subsidiaries are proud to be EEO employers.
Equal Opportunity Employer
This employer is required to notify all applicants of their rights pursuant to federal employment laws.
For further information, please review the Know Your Rights notice from the Department of Labor.

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