Senior Manager, Regulatory Affairs - CDMO - New York

New York, New York Permanent USD130,000 - USD170,000 per year
  • Join rapidly growing CDMO with state of the art manufacturing facility
  • Build out the entire Regulatory function from the ground up as first hire

About Our Client

My client was newly founded in the United States in 2022 with the global parent company operating for the past decade. They have a full suite of cGMP biologics/antibody development and manufacturing capabilities for both large and small companies. Their United States facilities are state of the art and pioneering the next phase of drug development and manufacturing. With rapid growth over the past 8 months, they play to hire an additional 50 employees by the end of the year.

Job Description

As the Senior Manager of Regulatory Affairs, you will play a pivotal role in shaping and leading the regulatory function within the organization. You will be the first hire within the regulatory group, responsible for building and establishing the entire regulatory framework. With a deep understanding of FDA regulations, cGMP, CMC, and regulatory submission processes, you will drive regulatory strategy, submissions, and compliance, while collaborating closely with cross-functional teams including manufacturing and quality.

  • Develop and execute regulatory strategies to ensure successful product development, registration, and commercialization, in line with industry standards and FDA regulations.
  • Lead the preparation, compilation, and submission of regulatory dossiers, including INDs, BLAs, and other relevant submissions, ensuring accuracy, completeness, and timeliness.
  • Provide expert guidance on CMC (Chemistry, Manufacturing, and Controls) aspects, ensuring alignment with regulatory requirements.
  • Collaborate closely with cross-functional teams to integrate regulatory requirements into manufacturing processes, ensuring compliance with cGMP and other relevant standards.
  • Stay up-to-date with evolving regulatory guidelines, assessing their impact on our operations, and proactively adjusting strategies and processes as necessary.
  • Represent the company in interactions with regulatory authorities, leading discussions and negotiations as needed.
  • Mentor and develop regulatory team members as the group expands, fostering a culture of excellence, collaboration, and continuous improvement.

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

The Successful Applicant

  • B.S., M.S.m of Ph.D. in a scientific discipline or related field.
  • Minimum of 10 years of experience in the biopharmaceutical industry with 5+ years of direct experience in regulatory affairs, including experience with FDA, EU, ICH, PIC/S guidelines and cGMP/CMC requirements.
  • Proven track record of successful regulatory submissions for biologics products
  • Strong knowledge of current regulatory guidelines and standards, with the ability to interpret and apply them effectively.
  • Previous experience within a Contract Development Manufacturing Organization (CDMO) or similar environment is highly advantageous and preferred.
  • Excellent leadership, communication, and interpersonal skills, with the ability to influence and collaborate across functions.

What's on Offer

  • Competitive base salary
  • First hire in Regulatory Team at entire site
  • Opportunity to grow and build out Regulatory function
  • On-site position in Western New York
  • State of the art manufacturing facility
  • Excellent benefits package
  • Relocation package
  • Pivotal role for company's aggressive expansion
Contact
Connor Colombo
Quote job ref
JN-082023-6153684

Job summary

Sector
Life Sciences
Sub Sector
Biotechnology
Industry
Healthcare / Pharmaceutical
Location
New York
Contract Type
Permanent
Consultant name
Connor Colombo
Job Reference
JN-082023-6153684