Mgr CMC Regulatory Intelligence

We are currently looking to fill a Manager, CMC Regulatory Intelligence position. The role entails proactive monitoring and communicating of changes in the global chemistry, manufacturing, and controls (CMC) regulatory landscape to ensure the manufacturing organization remains in compliance with global regulatory requirements.

As a Manager, CMC Regulatory Intelligence, a typical day might include the following:

• Supervise and assess global CMC regulatory intelligence information for relevance and impact to the company’s internal processes, drug development projects and/or regulatory strategies and communicate effectively to internal stakeholders.
• Establish working groups, facilitate discussions, and lead presentations that examine regulatory intelligence and analysis on emerging trends and risks by bringing together subject matter experts from across all departments and levels to ensure compliance.
• Engage with the quality management system to record and track actions required to stay in compliance with new and updated regulatory guidance.
• Collaborate with Regeneron Regulatory Intelligence Department to facilitate commenting on regulatory drafts for public comment and monitor evaluation and implementation of final CMC regulation or guidelines.
• Write CMC regulatory intelligence reports/newsletters that are distributed to the manufacturing organization.
• Provide CMC regulatory intelligence support for queries and requests related to global CMC requirements.
• May be consulted on global regulatory strategy for CMC change controls to ensure compliance with current regulatory guidance.
• Where applicable, represent Regeneron on industry teamwork forums that examine existing and emerging CMC topics to produce connected solutions that drive change.
• Participate in shaping the tools and processes supporting regulatory intelligence operations at Regeneron.

This role may be for you if you:

• Strong project management leadership skills essential
• Good understanding of the drug development and commercialization process, with a focus on CMC
• Experienced in understanding and interpreting regulatory guidelines and documents
• Ability to research, analyze and extrapolate critical regulatory information
• Team-oriented and strong relationship builder, ability to effectively collaborate with a range of individuals across the organization at all levels

To be considered you must have the following education and requirements.

• A completed life science degree (BS/BA)
• 6 years of experience in the pharmaceutical industry with a focus on Regulatory and/or Quality Assurance and cGMP compliance

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides comprehensive benefits including health and wellness programs, fitness centers and 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. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.
The salary ranges provided are shown in accordance with U.S. law and apply to U.S. based positions, where the hired candidate will be located in the U.S. If you are outside the U.S, please speak with your recruiter about salaries and benefits in your location.
$101,800.00 - $166,000.00

Salary : $101,800 - $166,000