Assoc CMC Regulatory Sciences Specialist

Regeneron; United States; Presencial; USD 62.000 - 92.000; Tempo integral

Resumo da vaga

Regeneron 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 marketing submissions and coordinate responses to agency inquiries to meet timelines.

The role emphasizes collaboration with cross-functional teams, contract manufacturers and regulatory partners, applying FDA/ICH CGMP guidelines and contributing to CMC regulatory strategy. On-site work is required in many cases.

Qualificações

• BA/BS degree or equivalent required.
• 2 years of relevant experience for Specialist level.
• 5 years of relevant experience for Senior Specialist level.
• Degree in a scientific field preferred.
• Advanced degree preferred.

Responsabilidades

• Prepare global CMC documents for regulatory submissions.
• Coordinate authoring, review and responses to CMC inquiries.
• Collaborate with cross-functional teams and external partners.
• Apply regulatory guidance and CGMP knowledge.
• Review CMC documents for completeness and regulatory compliance.
• May oversee projects and staff assignments.

Conhecimentos

Regulatory knowledge

CMC submissions

Communication

Project management

Formação

BA/BS degree

Scientific degree preferred

Descrição da vaga

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 include, but are not limited to, the following:

• 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.

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. If you have any questions, please speak with your recruiter.

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. Please speak with your recruiter and hiring manager for more information about on‑site expectations for your role and location.

As part of the recruitment process, certain background checks may be conducted in accordance with the laws of the country where the position is based. The purpose of such checks is to verify certain information prior to the commencement of employment such as identity, right to work and educational qualifications.

For jobs in Canada: this posting is for an existing position.

Salary Range (annually)

$62,355.00 - $92,400.00