Associate Director CMC Regulatory Sciences

1 month ago

Troy, Michigan, United States Regeneron Pharmaceuticals, Inc. Full time

Regeneron is seeking a highly motivated and experienced Associate Director of CMC Regulatory Sciences to join our global team. This role is pivotal in leading post-approval commercial and global lifecycle management activities for Regenerons portfolio of commercial products. The ideal candidate will have demonstrated leadership skills and the ability to direct a function effectively.

As an Associate Director of CMC Regulatory Sciences your remit will include the following:

Leading and managing the global CMC Regulatory Sciences Post-Approval Commercial team, providing strategic direction and oversight Fostering a collaborative and innovative environment, encouraging team development and growth Building and leading relationships with partners, regulators, and internal/external organizations Establish key performance indicators and capacity of the team and manage resources across program portfolio according to business priority Supervising post-approval regulatory activities, including new registrations, variations, and renewals Interacting with regulatory authorities from US, Canada, and other international health agencies in support of CMC topics Providing updates and reports to senior leadership on regulatory status and progress Being accountable for the performance of the post-approval commercial team Leading all aspects of development and execution of CMC regulatory strategies for new and existing products Ensuring alignment of CMC regulatory strategies with overall business objectives Ensuring the accuracy, quality, and clarity of written technical information/communications and ensure compliance with global regulatory requirements and guidelines Monitoring changes in regulatory landscapes and industry trends and collaborate cross-functionally to drive improvements in the business This role might be for you if: You demonstrate leadership experience, with the ability to direct a global function effectively You possess in-depth knowledge of global regulatory requirements and guidelines You display strong technical skills and understanding of biopharmaceutical manufacturing processes and controls You have strong strategic thinking and problem-solving skills You possess excellent communication and interpersonal skills You thrive in a multifaceted and fast-paced environment To be considered for this opportunity you should have a BS/BA in Life Sciences or a related field and 10+ years of relevant work experience. Relevant experience may be substituted in lieu of educational requirement. #LI-Onsite # #JOBSIEPR #IREADV

Does this sound like you? Apply now to take your first step towards living the Regeneron Way We have an inclusive and diverse culture that provides comprehensive benefits, which often include (depending on location) health and wellness programs, fitness centers, 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. The Company will also provide reasonable accommodation to the known disabilities or chronic illnesses of an otherwise qualified applicant for employment, unless the accommodation would impose undue hardship on the operation of the Company's business.

For roles in which the hired candidate will be working in the U.S., the salary ranges provided are shown in accordance with U.S. law and apply to U.S.-based positions. For roles which will be based in Japan and/or Canada, the salary ranges are shown in accordance with the applicable local law and currency. If you are outside the U.S, Japan or Canada, please speak with your recruiter about salaries and benefits in your location.

Please note that certain background checks will form part of the recruitment process. Background checks will be conducted in accordance with the law of the country where the position is based, including the type of background checks conducted. The purpose of carrying out such checks is for Regeneron to verify certain information regarding a candidate prior to the commencement of employment such as identity, right to work, educational qualifications etc.

  • Client Director

    3 weeks ago

    Troy, Michigan, United States opentext Full time

    OPENTEXT OpenText is a global leader in information management, where innovation, creativity, and collaboration are the key components of our corporate culture. As a member of our team, you will have the opportunity to partner with the most highly regarded companies in the world, tackle complex issues, and contribute to projects that shape the future of...

  • Senior Director of Data Management

    2 days ago

    Troy, Michigan, United States New York Community Bank Full time

    About the RoleThe Senior Director of Data Management will provide vision and strategy for all data management activities at New York Community Bank. This position will act as the champion of data management, governance, and quality for the organization.Key ResponsibilitiesCreate a comprehensive data management strategy that aligns with the bank's business...

  • Rehabilitation Associate

    13 hours ago

    Troy, Michigan, United States Premier Health Partners Full time

    Job SummaryWe are seeking a highly skilled and detail-oriented Rehabilitation Associate to join our team at Premier Health Partners. As a key member of our healthcare team, you will be responsible for providing exceptional patient care and support services.Key ResponsibilitiesFinancial Counseling: Provide financial counseling to patients and their families,...

  • Loan Servicing Associate I

    6 days ago

    Troy, Michigan, United States Michigan Schools and Government Credit Union Full time

    Michigan Schools & Government Credit Union (MSGCU) has been a pillar of financial support in the community for 70 years, dedicated to empowering individuals across Michigan. As the sixth largest credit union in the state, we pride ourselves on our commitment to our members, boasting over 140,000 satisfied clients and a robust asset base of $3.5 billion. Our...

  • Facility Maintenance Associate

    6 days ago

    Troy, Michigan, United States ABM Full time

    Available Shifts: Monday to Friday 5am - 1:30pm OR Monday to Friday 2:30pm - 11pm The Facility Maintenance Associate is responsible for the cleanliness and maintenance of designated areas.Benefits Overview: ABM provides a comprehensive benefits package. For details regarding ABM's benefits, please refer to the company resources. Essential Qualifications:...

  • HV Power Generation Operator

    11 hours ago

    Troy, Michigan, United States InsideHigherEd Full time

    Position Type: Full-timeLocation: Troy, New York, United StatesApplication closes:Founded in 1953, Hudson Valley Community College (HVCC) is a prominent educational institution offering a diverse range of degree and certificate programs across three schools: Business and Liberal Arts, Health Sciences, and Science, Technology, Engineering, and Math (STEM)....

  • HV Power Generation Operator

    6 days ago

    Troy, Michigan, United States InsideHigherEd Full time

    Position Type: Full-timeLocation: Troy, New York, United StatesApplication closes:Founded in 1953, Hudson Valley Community College (HVCC) is a distinguished multi-campus institution situated in scenic Upstate NY, with campuses in Troy and Malta.HVCC provides a diverse array of over 80 degree and certificate programs across three primary schools: Business and...

  • HV Power Generation Operator

    4 hours ago

    Troy, Michigan, United States InsideHigherEd Full time

    Position Type: Full-timeLocation: Troy, New York, United StatesApplication closes:Founded in 1953, Hudson Valley Community College (HVCC) is a prominent educational institution located in scenic Upstate NY, offering a diverse range of degree and certificate programs across three schools: Business and Liberal Arts, Health Sciences, and Science, Technology,...

  • Fitness Membership Sales Associate

    6 hours ago

    Troy, Michigan, United States CycleBar of United Fitness Full time

    Job OverviewCycleBar of United Fitness is on the lookout for a dedicated Membership Sales Associate to join our innovative team. Our ideal candidate is enthusiastic about fitness and committed to providing an exceptional customer experience. The primary focus of this role is to enhance sales and drive revenue within our studio.Key Responsibilities:Support...

  • Senior Power Generation Technician

    4 hours ago

    Troy, Michigan, United States InsideHigherEd Full time

    Position Type: Full-timeLocation: Troy, New York, United StatesApplication closes:Founded in 1953, Hudson Valley Community College (HVCC) is a distinguished institution located in the picturesque Upstate NY, operating multiple campuses in Troy and Malta.HVCC provides a diverse array of over 80 degree and certificate programs across three primary schools:...

  • Human Resources Director

    11 hours ago

    Troy, Michigan, United States Dunham's Sports Full time

    Job SummaryDunham's Sports, a leading Midwest Specialty Sporting Goods retailer, is seeking a highly skilled Human Resources Manager to join our team. As a key member of our HR department, you will play a critical role in administering pay, benefits, and leave, while ensuring compliance with federal, state, and local employment laws and regulations.Key...

  • Product Marketing Associate

    2 months ago

    Troy, Michigan, United States Aptiv Full time

    Summary:We're seeking a highly motivated Product Marketing associate to support content development for our next-generation AS&UX offerings aligned to our go-to-market strategy. Our ideal candidate will show initiative by diving in alongside a talented team to support and grow a profitable and sustainable multi-billion dollar business. You will be a part of...

  • Healthcare Coding Education Specialist

    6 days ago

    Troy, Michigan, United States Henry Ford Health Full time

    Are you prepared to connect clinical expertise with coding proficiency? Transforming Healthcare Documentation and Coding: If you are enthusiastic about enhancing healthcare processes, this role may be ideal for you. The Medical Coding Education Coordinator position offers the flexibility of 95% remote work, with occasional travel required. Enjoy a work-life...

  • Head of IT Risk Management

    6 days ago

    Troy, Michigan, United States Flagstar Bank Full time

    Position Overview: The Head of IT Risk Management is tasked with the formulation and execution of a comprehensive IT risk management strategy that aligns with the broader Enterprise Risk Management framework at Flagstar Bank. This role is pivotal in identifying, evaluating, and prioritizing both current and potential IT risks throughout the organization. The...

  • Rehabilitation Support Specialist

    6 days ago

    Troy, Michigan, United States Premier Health Partners Full time

    Premier Health PartnersRehabilitation Support SpecialistPRN - *AS NEEDED, 8 HOUR SHIFTSThe Rehabilitation Support Specialist at Premier Health Partners plays a crucial role in assisting patients and their families with financial guidance, managing appointment schedules, verifying insurance details, and ensuring adherence to regulatory standards. This...

  • Fraud Prevention and Risk Analysis Specialist

    6 days ago

    Troy, Michigan, United States Flagstar Bank, N.A. Full time

    Position Title: Fraud Prevention and Risk Analysis SpecialistJob Summary: The Fraud Prevention and Risk Analysis Specialist plays a pivotal role in safeguarding against fraudulent activities across various banking sectors, including consumer, commercial, and small business check processing. This position is crucial for identifying and mitigating risks...

  • Information Security Specialist

    6 days ago

    Troy, Michigan, United States Venteon Full time

    The Information Security Specialist at Venteon will be instrumental in protecting the organization's digital assets by overseeing, evaluating, and addressing security threats. This position is tailored for a dynamic environment typical of small to mid-sized enterprises, where flexibility and practical experience are essential.Core...

  • RBO Risk Management Specialist

    3 weeks ago

    Troy, Michigan, United States Flagstar Bank Full time

    Position Title RBO Risk Management Specialist Location Troy/5151 Corporate Drive/112300 Job Summary The RBO Risk Management Specialist is primarily responsible for preventing fraud loss across consumer, commercial and small business check processing. Analysis of checks presented for payment to identify fraud activity and anomalous activity is the primary...

  • Executive Administrative Coordinator

    6 days ago

    Troy, Michigan, United States Harvard Resource Solutions LLC Full time

    We are currently seeking an Executive Administrative Coordinator for our nonprofit client.Location: Troy, MITitle: Executive Administrative CoordinatorWorking Arrangement: Hybrid (In-office on designated days)Reason for Opening: Open VacancyPosition OverviewThe successful candidate will be responsible for:Reconciling monthly grant records and assisting in...

  • Print Production Specialist

    8 hours ago

    Troy, Michigan, United States InsideHigherEd Full time

    Position Type: Part-time Location: Troy, New York, United States Application closes: Founded in 1953, Hudson Valley Community College (HVCC) is a prominent institution in Upstate NY, offering a diverse range of over 80 degree and certificate programs across three schools: Business and Liberal Arts, Health Sciences, and Science, Technology, Engineering, and...