Staff CMC Regulatory Specialist - Commercial Submissions

BioSpace; City of Troy (NY); On-site; USD 90,000 - 203,000; Full time

Job summary

A leading biopharmaceutical company seeks a highly motivated Staff CMC Regulatory Specialist for overseeing Chemistry, Manufacturing, and Controls for commercial submissions. This role involves ensuring compliance with regulatory standards and supporting CMC strategies across markets. Ideal candidates will have significant experience in CMC regulatory settings and strong technical writing skills.

Benefits

Health and wellness programs

Fitness centers

Annual bonuses

Paid time off for eligible employees

Qualifications

• 8-12 years of relevant experience in biopharmaceutical or CMC regulatory setting.
• Strong knowledge of CMC regulatory requirements.
• Ability to manage Module 3: Quality submissions.

Responsibilities

• Oversee Chemistry, Manufacturing, and Controls aspects of submissions.
• Ensure compliance with US and ex-US regulatory standards.
• Prepare, coordinate, and compile Module 3 for license applications.

Skills

Technical writing

Project management

Communication

Cross-functional teamwork

Education

BS/BA degree in a scientific discipline

Advanced degree (MS or PhD)

Job description

Staff CMC Regulatory Specialist - Commercial Submissions

Join to apply for the Staff CMC Regulatory Specialist - Commercial Submissions role at BioSpace

Staff CMC Regulatory Specialist - Commercial Submissions

1 week ago Be among the first 25 applicants

Join to apply for the Staff CMC Regulatory Specialist - Commercial Submissions role at BioSpace

We are seeking a highly motivated and experienced Staff CMC Regulatory Sciences Specialist (Commercial Submissions) to join our dynamic CMC Regulatory Sciences team. The successful candidate will play a critical role in overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of commercial submissions, ensuring compliance with US and ex-US regulatory standards. Strong technical writing skills are essential for effectively communicating complex scientific information.

As a Staff CMC Regulatory Sciences Specialist, a typical day might include the following:

• Create and refine processes and tools for the preparation of global marketing applications.
• Support the development and execution of CMC regulatory strategies for US and ex-US markets.
• Oversee the preparation, coordination, and compilation of Module 3: Quality (CMC information) for license applications, ensuring alignment with applicable regulations and guidelines.
• Ensure that all written materials meet regulatory standards and effectively convey the necessary information to regulatory authorities.
• Assist in the timely and accurate assembly of responses to regulatory agency inquiries.
• Act as the project manager related to program submission strategies, including timelines, approach, and deliverables. Maintain clear communication with all stakeholders and escalate risks with mitigation options as necessary.
• Stay informed on regulatory trends, changes, and agency feedback and update relevant submission planning processes to reflect these changes.
• When applicable, engage with regulatory authorities to support the CMC modules of regulatory submissions.
• May have direct reports.
  
  
  

This Role May Be For You If You Have

• Strong project management and communication skills.
• Ability to work effectively in a cross-functional team environment.
• Experience managing Module 3: Quality (CMC information) submissions, reviews, and approvals
• Strong knowledge of CMC regulatory requirements and guidelines in at least one major market.
• Excellent written and verbal communication skills, particularly in technical writing.
• Can work cross-functionally and manage multiple projects simultaneously.
  
  
  

In order to be considered for this position, you must hold a BS/BA degree in a scientific discipline and

• Principal CMC Regulatory Sciences Specialist: 8 years of relevant experience in a biopharmaceutical and/or CMC regulatory or industry setting
• Staff CMC Regulatory Sciences Specialist: 10 years of relevant experience in a biopharmaceutical and/or CMC regulatory or industry setting
• Senior Staff CMC Regulatory Sciences Specialist: 12 years of relevant experience in a biopharmaceutical and/or CMC regulatory or industry setting
• May consider experience in lieu of education; level decided upon completion of an interview process
• Advanced degree preferred (MS or PhD).
  
  
  

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, equity awards, annual bonuses, and paid time off for eligible employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or parental status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

Salary Range (annually)

$90,800.00 - $203,000.00

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Legal

• Industries

  Internet News

Referrals increase your chances of interviewing at BioSpace by 2x

Get notified about new Regulatory Specialist jobs in Troy, NY.

Staff CMC Regulatory Specialist - Commercial Submissions

Senior CMC Regulatory Specialist - Commercial Submissions

Compliance Specialist (Regulatory Affairs)

Senior CMC Regulatory Specialist - Commercial Submissions

Specialist Quality Improvement (Residential S

Associate Attorney – Energy, Utility & Regulatory

Albany, NY $115,000.00-$150,000.00 3 days ago

Quality Assurance Specialist III (Analytical Labs)

Albany, NY $73,000.00-$91,600.00 2 weeks ago

Ballston Spa, NY $75,000.00-$85,000.00 22 hours ago

Ballston Spa, NY $75,000.00-$85,000.00 3 days ago

Principal QA Validation Specialist (Aseptic Fill Finish)

Principal QA Validation Specialist (Aseptic Fill Finish)

Financial Risk - Regulatory Reporting - Manager

Clinical Manager - New York State - Field

Albany, NY $106,604.71-$170,567.55 2 weeks ago

Schenectady, NY $140,252.00-$140,252.00 1 week ago

We’re unlocking community knowledge in a new way. Experts add insights directly into each article, started with the help of AI.