Regulatory Affairs Director, CMC (Biologicals) – Remote - Provide regulatory strategic support for global activities (IND/CTAs/NDAs/BLAs/MAAs)

Reference: KLT514A

Expiry Date: 29-11-2022

Categories Biotech, Regulatory Affairs

Salary: Competitive

Job Type: Full Time

San Francisco County
Съединени щати
Remote Working

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Job Description

Location: Remote, if based on the West Coast (Washington, California, Oregon)

Our client is an established and medium sized global biopharmaceutical company with a robust and innovative pipeline, who have been bringing forward transformative therapies to address unmet needs across a number of interesting therapy areas for over a hundred years.  As they continue to grow, they are moving into new modalities and expanding/moving products into new regions. The pipeline is well balanced with indications in Phases 2 and 3, and they have a recently filled product (via a successful BLA), where there are plans to register next into China, Japan, Brazil, and Canada.

With operations on both the East and West Coast, and also in Central Europe, this is a global organization that is offering the opportunity for you to be fully remote.  You will also be joining a company consistently rated by employees (and also within the industry) as one of the vest places to work, who listen and learn from patients and care partners so that they can bring forward better solutions.

Reporting into the VP of Global Regulatory affairs you will be responsible for providing regulatory strategic support for global regulatory activities for innovative biologicals throughout the lifecycle of the product (IND/CTAs/NDAs/BLAs/MAAs) from early development through to global commercialization, so a full project lifecycle role.

This position is seen as key role in the continued growth and development of this expanding Global Biologicals Regulatory CMC team, and you will like this position if:

  • You want to work in a Global role that covers US/EU development and new lifecycle regimes
  • You want to lead the strategic input for commercialized products to major countries including China, Japan, Brazil, Canada  
  • You want to lead a BLA for a highly rated indication
  • You want to join an organization ranked in the top tier for a number of categories including patient-centricity and corporate integrity

Employee Benefits:

You will receive a comprehensive benefits package that includes Medical, Dental, Life insurance, Short-term disability, Long-term disability, discounted childcare, numerous employee discounts, extended parental leave, a generous 401k retirement plan and over 5 weeks of PTO.

On offer is very competitive package at Director grade, including strong basic, bonus and stock, but you will also have the opportunity to work remotely or if you prefer in a Hybrid home/office system.


To Apply!

To apply for this role, please press the red “Apply for position” button, or contact me, Theo Moore, on US 908-348-6714 or send us a copy of your resume to We will support you throughout the interview and on-boarding experience!

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