Temp - CMC Regulatory Affairs Manager

Regeneron Pharmaceuticals, Inc.; United States; Hybrid; USD 90,000 - 130,000; Full time

Job summary

Regeneron Pharmaceuticals, Inc. in Warren is seeking a Temporary-Manager, CMC Regulatory Affairs to help shape regulatory compliance and strategy for biologics and combination products.

This role offers on-site or remote work within the US and opportunities to contribute to a fast-growing science-driven organization making a meaningful difference to patients. You will support activities from early phase through post-market, review regulatory filing documents for compliance, develop regulatory

Qualifications

• Bachelor's degree with 6+ years in pharma/biotech, or an advanced degree with 3+ years.
• 2–4 years of worldwide CMC regulatory affairs experience.

Responsibilities

• Support regulatory activities from early phase through post-market.
• Review regulatory filing documents for compliance with regulations.
• Develop regulatory strategies and participate in global RA meetings.
• Create working instructions and SOPs for CMC/CP RA units.

Skills

CMC regulatory affairs

Regulatory submissions

FDA interactions

Biologics

Education

Bachelor's degree in a relevant field

Advanced degree

Job description

At Regeneron, we use science and innovation to develop life-changing medicines for people with serious diseases. We are seeking a Temporary-Manager, CMC Regulatory Affairs, to join our Global Regulatory Affairs organization in Warren in an on-site or remote work model. In this role, you will help shape regulatory compliance and strategy for biologic and combination products across the assigned portfolio, while collaborating with cross-functional IOPS teams. This position offers the opportunity to contribute to a fast-growing, science-driven organization making a meaningful difference to patients worldwide.

CMC Regulatory Affairs Manager - R50287

Location

Warren or remote in the US

Roles Responsibilities

• Support CMC/Combination product development activities from a regulatory standpoint during early phase, development, submissions and post market requirements.
• Perform the compliance activities of the portfolio to determine regulatory impact and associated submission requirement for clinical and commercial regulatory filings. Assist specialists and colleagues in regulatory assessment of compliance tasks.
• Review the content and format of regulatory filing documents ensuring compliance with applicable regulations and guidelines governing the development, licensure, and marketing of drugs and/or biologics.
• Participate in global RA meetings and help to develop regulatory strategies. Participate in communications between Global RA and IOPS as needed.
• Support preparations for interactions with global regulatory authorities (e.g., meetings, IR responses).
• Develop and create Working Instructions, SOPs, and/or Reviewer’s Guide to facilitate consistent and efficient practice across the CMC/CP RA units.
• Identify gaps in the IOPS and global RA processes, raise to higher management, help to improve business efficiency.
• Participate in IOPS cross-functional meetings for program-specific discussions, connect the dots across IOPS, proactively identify CMC/CP regulatory issues and suggest appropriate strategies to mitigate or fix them, translates ambiguity into actionable steps. Ensure appropriate communications between IOPS and global RA in a timely manner.
• Contribute to the CMC/CP RA group development (e.g., discussion, presentation, generation of deliverables for training programs).

Skills

• Bachelor's degree with a minimum of 6 years of relevant pharmaceutical/biotech industry experience, or an advanced degree with 3 years of experience, including 2-4 years of relevant worldwide CMC regulatory affairs experience.
• Combination products is a plus.
• Experience delivering CMC sections of marketing authorizations, clinical trial applications (CTA/IND), and post-approval submissions for biologic products or combination products is an advantage.
• Experience interacting with FDA or other regulatory health authorities is an advantage.

Education

• Bachelor's degree or advanced degree in a relevant field.