Assoc CMC Regulatory Sciences Specialist

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

Job summary

Regeneron Pharmaceuticals, Inc. is seeking a regulatory professional to provide Chemistry, Manufacturing, and Controls (CMC) support across its sites.

You will prepare global CMC documents for clinical and commercial submissions, ensuring accuracy and compliance with FDA and ICH guidelines. In this role you will manage authoring, review, and finalization of CMC submissions, coordinate with cross-functional teams and external partners, and help develop regulatory strategies.

Qualifications

• BA/BS degree or equivalent is required.
• Degree in a scientific field preferred.
• Advanced degree preferred.

Responsibilities

• Prepare global CMC documents for regulatory submissions.
• Coordinate authoring, review, and finalization of CMC documents.
• Collaborate with cross-functional teams and external partners.
• Identify issues and contribute to risk mitigation strategies.
• Prepare for meetings with global regulatory authorities.

Job description

Summary: Responsible for providing Chemistry, Manufacturing, and Controls (CMC) support across Regeneron's sites. Routine activities include dossier development for clinical trial applications, marketing applications, amendments, post approval variations and other regulatory submissions.

Essential Duties and Responsibilities

• Prepares global CMC documents and sections for a variety of clinical and commercial biopharmaceutical regulatory submissions, ensuring that all submissions are complete, accurate and meet relevant requirements.
• Manages and coordinates the authoring, review and finalization of CMC documents and responses to CMC-related inquiries from Regulatory agencies, in accordance with submission timelines, keeping all stakeholders, including external partners, informed of progress.
• Collaborates and develops excellent relationships with functional area and cross functional teams, contract manufacturing organizations and global Regulatory partners.
• Applies in-depth understanding of regulatory guidance and regulations, as well as industry and government agency best practices and trends.
• May review relevant CMC documents and reports for completeness, accuracy and compliance with regulations and regulatory guidance.
• May proactively identify issues and contributes to the development of appropriate strategies to mitigate risk.
• May assist in preparation for meetings with global regulatory authorities.
• May contribute to developing CMC regulatory strategy.
• May review regulatory submission documents to ensure that all submissions are complete, accurate and meet relevant requirements.
• May oversee and assign projects to other specialists; may have direct reports.

Education and Experience

• Associate Specialist: Requires BA/BS degree or equivalent combination of education and experience.
• Specialist: Requires BA/BS degree and 2 years of relevant experience or equivalent combination of education and experience.
• Senior Specialist: Requires BA/BS degree and 5 years of relevant experience or equivalent combination of education and experience.
• Degree in a scientific field preferred.
• Advanced degree preferred.

Knowledge, Skills and Abilities

• Excellent written and verbal communication skills.
• Ability to work independently, prioritize, coordinate and complete multiple projects within deadline while maintaining a high level of attention to detail.
• Knowledge of relevant drug development regulations and guidelines (i.e. FDA regulations and ICH guidelines) as well as an understanding of CGMPs (Current Good Manufacturing Practices).
• Strong skills in planning, critical thinking and problem-solving.

Does this sound like you?

We are committed to building a workplace with an inclusive culture.

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, sexual orientation, gender identity or expression, gender reassignment, marital or civil partnership status, civil status, pregnancy or parental status, age, disability, nationality, citizenship status, ethnic or national origin, membership of the Traveler community, familial status, genetic information, military or veteran status, or any other characteristic protected under applicable law. Where required, we will provide reasonable accommodation to applicants with known disabilities or chronic illnesses during the recruitment process, unless such accommodation would impose undue hardship.

Where necessary, we disclose salary ranges for roles in all countries in which we operate. The final offer will be determined within the relevant range based on the country of employment, specific role level, and your skills and experience. In some countries, collective bargaining agreements (CBAs) may apply and influence certain elements of pay or benefits. Regeneron offers a competitive and comprehensive total rewards package which may include, depending on country and role: annual bonuses or other incentive plans, equity awards, pension or retirement benefits, 401(k) company match, health and wellness programs, fitness centers, insurance benefits (e.g. medical, dental, vision, life and disability), paid time off, and family support benefits. For additional information about Regeneron benefits in the U.S., please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/ . For other locations, additional information will be provided during the recruitment process.

Please be advised that at Regeneron, we believe we do our best work when we are together. For that reason, many roles are required to be performed on‑site.