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Director, CMC Industry and Regulatory Intelligence

Employer
Regeneron Pharmaceuticals, Inc.
Location
Troy, New York
Start date
Feb 16, 2024

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Job Details

The Director of CMC Industry and Regulatory Intelligence is responsible for enabling chemistry manufacturing and controls (CMC) quality and compliance excellence by ensuring Regeneron IOPS maintains effective systems for monitoring, analyzing, communicating, implementing, and influencing global regulatory and industry trends, regulations, and pharmacopoeia. In this role, you will be expected to develop and implement strategies to translate CMC intelligence gathering into action and influence policy and standards for all CMC operations across Regeneron.

As a Director of CMC Industry and Regulatory Intelligence, a typical day might include the following

  • Provides oversight on the IOPS CMC intelligence program
  • Collaborates with the Regulatory Intelligence and GMP Compliance and Inspections teams to support and drive activities that ensure appropriate regulatory intelligence and compliance information is maintained and made available throughout IOPS
  • Monitors and assesses all sources of global CMC intelligence information, including industry trends, for relevance and impact to internal processes, drug development projects and/or regulatory strategies and ensures that internal procedures are introduced or adapted to respond to changes in the regulatory environment
  • Develops internal guidance, position papers, training materials and communications to ensure leadership and staff are informed on regulatory compliance information, risks and trends, and how existing procedures might need to be amended to remain in compliance
  • Develops and implements strategies to ensure that our products and processes are compliant with relevant regulations, collaborates with internal and external stakeholders, and provides guidance to teams across the organization
  • Establishes working groups, facilitates discussions, and leads presentations that examine regulatory intelligence and analysis of emerging trends and risks by bringing together subject matter experts from across all departments and levels to ensure compliance
  • Engages in industry trade/professional associations in leadership positions to represent Regeneron and influence the external regulatory environment. Contributes to conference presentations, journal publications, and actively participates in appropriate professional bodies and regulatory forums

This role may be for you if you have:

  • Experience working in complex and matrix environment. Strong negotiation skills to reach consensus. Strong communication skills, both oral and written.
  • 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

In order to be considered for this position, you must hold a bachelor's degree in life science, preferably related to health, environment or politics or related degree and:

  • Associate Director: 15+ years of related experience in regulated industry or health authority
  • Director: 18+ years of related experience regulated industry or health authority
  • Senior Director: 20+ years of related experience regulated industry or health authority
  • Preferred Education: Relevant Masters degree in a scientific, health, legal or business discipline. Regulatory certifications a plus.
  • Experience can be in lieu of education; leveling is decided on during an interview process

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.

Salary Range (annually)

$142,700.00 - $326,900.00

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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