Director, Regulatory Affairs CMC

1 week ago


Rockville MD United States Proclinical Staffing Full time

Director, Regulatory Affairs CMC - Permanent - Rockville, MD

Are you passionate about driving impactful regulatory strategies in a rapidly evolving environment?

Proclinical is working with a leading biotech company dedicated to advancing therapies for unmet medical needs. This role is a fantastic opportunity to make a difference across the entire product lifecycle and contribute to the development of cutting-edge therapies.

Primary Responsibilities:

As a Director in Regulatory Affairs - CMC, the successful candidate will be the go-to expert for global CMC strategy, overseeing regulatory submissions and aligning with cross-functional teams in CMC, Manufacturing, and Quality. This role will guide the development and implementation of CMC plans, ensuring compliance across major territories. Working closely with regulatory leadership, this role will contribute to the strategic and operational goals of high-impact projects.

Skills & Requirements:

The successful candidate must have over 10 years of experience in regulatory affairs or related fields, and be an expert in biologics and advanced therapies. Possessing strong technical writing skills, an in-depth understanding of ICH and FDA guidelines, and the ability to lead complex regulatory projects in a collaborative, matrixed environment.

The Director, Regulatory Affairs' responsibilities will be:

  • Shape and execute CMC strategies and regulatory submissions
  • Lead cross-functional collaborations to provide regulatory guidance
  • Participate in product teams, advising on CMC and regulatory compliance
  • Plan, author, and review strategic regulatory documents for submissions
  • Maintain awareness of evolving regulatory requirements and trends

Compensation:

  • $215,000 to $220,000 per annum.

If you're ready to make a meaningful impact in a role that challenges and rewards, we'd love to connect

Reach out to Nicholas Walker at N.Walker@proclinical.com

Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.



  • Rockville, MD, United States Proclinical Staffing Full time

    Director, Regulatory Affairs CMC Permanent - Rockville, MDAre you passionate about driving impactful regulatory strategies in a rapidly evolving environment?Proclinical is working with a leading biotech company dedicated to advancing therapies for unmet medical needs. This role is a fantastic opportunity to make a difference across the entire product...


  • Rockville, United States Proclinical Staffing Full time

    Director, Regulatory Affairs CMC - Permanent - Rockville, MDAre you passionate about driving impactful regulatory strategies in a rapidly evolving environment?Proclinical is working with a leading biotech company dedicated to advancing therapies for unmet medical needs. This role is a fantastic opportunity to make a difference across the entire product...


  • Rockville, United States Proclinical Staffing Full time

    Director, Regulatory Affairs CMC - Permanent - Rockville, MDAre you passionate about driving impactful regulatory strategies in a rapidly evolving environment?Proclinical is working with a leading biotech company dedicated to advancing therapies for unmet medical needs. This role is a fantastic opportunity to make a difference across the entire product...


  • Rockville, Maryland, United States Arcellx, Inc. Full time

    About Arcellx, Inc.Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by developing innovative immunotherapies for patients with cancer and other incurable diseases. Our mission is to destroy cancer and advance humanity by creating cell therapies that are safer, more effective, and more accessible.Job SummaryWe are seeking an...


  • Rockville, Maryland, United States Arcellx, Inc. Full time

    About Arcellx, Inc.Arcellx, Inc. is a clinical-stage biotechnology company reimagining cell therapy by developing innovative immunotherapies for patients with cancer and other incurable diseases. Our mission is to destroy cancer and advance humanity by creating cell therapies that are safer, more effective, and more accessible.Our TeamOur team members are...


  • Rockville, Maryland, United States GlaxoSmithKline Full time

    Job Title: Regulatory Affairs DirectorAt GlaxoSmithKline, we are committed to discovering and delivering transformational vaccines and medicines to prevent and change the course of disease. We are seeking a highly skilled Regulatory Affairs Director to join our team and play a key role in ensuring the development and execution of our regulatory strategy.Key...


  • Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration pathway,...


  • Boston, MA, United States Monte Rosa Therapeutics Full time

    Senior Manager, Regulatory Affairs - CMCLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our teams. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible for developing and implementing regulatory strategies to...


  • Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs. Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...


  • Princeton, NJ, United States Sun Pharma (Taro Pharma) Full time

    Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs.  Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...


  • Princeton, NJ, United States Sun Pharmaceutical Industries, Inc. Full time

    Senior Director, Global Regulatory Affairs Strategy The position will provide regulatory affairs strategic leadership for the company and novel drug development programs.  Of each program this position supports, the individual will be responsible for developing and executing the overall regulatory strategy, which includes developing the registration...


  • , IL, United States AbbVie Full time

    Job SummaryWe are seeking a highly skilled and experienced CMC Regulatory Specialist to join our team at AbbVie. As a key member of our regulatory affairs team, you will be responsible for leading global regulatory dossier preparation activities, coordinating cross-functional teams, and ensuring consistent preparation of high-quality regulatory submission...


  • Boston, MA, United States Takeda Pharmaceutical Full time

    By clicking the "Apply" button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda's Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge. Job...


  • Gaithersburg, MD, United States Invenia Group Full time

    Invenia is working with a growing manufacturer of scientific instrumentation to hire a Director of Regulatory Affairs.The company manufactures cell biology tools to advance workflows in the cell & gene therapy and bioproduction markets. They have an has an excellent culture and truly value their employees.The role:The Director of Regulatory Affairs will be...


  • Rockville, United States MaxCyte Inc Full time

    Job DescriptionJob DescriptionDescription:The Director, Regulatory Affairs will head the Regulatory function at MaxCyte. The Director, Regulatory Affairs develops and implements regulatory compliance and strategies that enable MaxCyte to meet business needs as well as safety, quality, and regulatory requirements. Utilizes knowledge of regulatory requirements...


  • Boston, MA, United States Spur Therapeutics Full time

    Why Spur?Gene therapy is at an inflection point. Amidst the noise of countless emerging modalities, we've been hard at work refining our science and advancing our programs with quiet determination and a bold ambition to unlock the true potential of gene therapy to change the trajectory of more patients' lives. Come join Spur's dedicated team of scientists,...


  • Boston, MA, United States AVEO Pharmaceuticals Full time

    JOB TITLE: Sr. Director, Global Regulatory Affairs REPORTS: Vice President, Regulatory Affairs DEPARTMENT: Regulatory Affairs DATE PREPARED: October 17, 2024 JOB SUMMARY: AVEO Oncology is seeking an experienced Senior Director, Regulatory Affairs who will develop and execute global regulatory strategies in support of the development for assigned...


  • Boston, MA, United States Monte Rosa Therapeutics Full time

    Director, Regulatory Affairs - Small Molecule StrategyLocation: Boston, MA USAMonte Rosa Therapeutics is seeking a highly skilled and self-motivated regulatory professional to join our team as an Associate Director of Regulatory Affairs. This role will focus on oncology, immunology, and related therapeutic areas. The successful candidate will be responsible...


  • Rockville, Maryland, United States Proclinical Staffing Full time

    Lead Regulatory Affairs for Innovative Biotech PortfolioProclinical Staffing is seeking a seasoned Regulatory Affairs professional to spearhead strategic regulatory decisions for a cutting-edge biotech portfolio.This key role will be responsible for guiding global regulatory pathways, overseeing a growing team, and reporting directly to the c-suite. The...


  • Rockville, Maryland, United States MaxCyte Inc Full time

    The Director, Regulatory Affairs will lead the Regulatory function at MaxCyte. The successful candidate will develop and implement regulatory compliance and strategies that enable MaxCyte to meet business needs, as well as safety, quality, and regulatory requirements.Key Responsibilities:Interpret and implement regulatory requirements and regulations to...