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Cmc Program Manager Jobs in Michigan (NOW HIRING)

Citizens

Mortgage Area Manager-MI, OH

Southfield, MI

$100K - $250K/yr

Enhance community awareness of CMC products and the attainment of CRA goals through conducting ... programs and more. Note, Citizens' paid time off policy exceeds the mandatory, paid sick or paid ...

Citizens

Mortgage Area Manager-MI, OH

Birmingham, MI

$100K - $250K/yr

Enhance community awareness of CMC products and the attainment of CRA goals through conducting ... programs and more. Note, Citizens' paid time off policy exceeds the mandatory, paid sick or paid ...

Citizens

Mortgage Area Manager-MI, OH

Birmingham, MI

$100K - $250K/yr

Enhance community awareness of CMC products and the attainment of CRA goals through conducting ... programs and more. Note, Citizens' paid time off policy exceeds the mandatory, paid sick or paid ...

Citizens Bank

Mortgage Area Manager-MI, OH

Southfield, MI · On-site

$100K - $250K/yr

Enhance community awareness of CMC products and the attainment of CRA goals through conducting ... programs and more. Note, Citizens' paid time off policy exceeds the mandatory, paid sick or paid ...

Citizens

Mortgage Area Manager-MI, OH

Southfield, MI · On-site

$100K - $250K/yr

Enhance community awareness of CMC products and the attainment of CRA goals through conducting ... programs and more. Note, Citizens' paid time off policy exceeds the mandatory, paid sick or paid ...

Citizens

Mortgage Area Manager-MI, OH

Southfield, MI

$100K - $250K/yr

Enhance community awareness of CMC products and the attainment of CRA goals through conducting ... programs and more. Note, Citizens' paid time off policy exceeds the mandatory, paid sick or paid ...

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Cmc Program Manager information

What are the key skills and qualifications needed to thrive as a CMC Program Manager, and why are they important?

To thrive as a CMC Program Manager, you need expertise in chemistry, manufacturing, and controls (CMC), project management experience, and an advanced degree in life sciences or a related field. Familiarity with regulatory submission systems, quality management tools, and certifications such as PMP or Six Sigma are highly valued. Strong leadership, cross-functional communication, and problem-solving skills help manage diverse teams and complex projects effectively. These skills ensure the successful development, regulatory compliance, and timely delivery of pharmaceutical products.

What are some typical challenges a CMC Program Manager faces when coordinating cross-functional teams?

A CMC Program Manager often encounters challenges in aligning the goals and timelines of diverse teams such as process development, analytical, regulatory, and manufacturing. Communication gaps and shifting priorities can complicate project execution, especially when managing external partners or contract manufacturing organizations. Proactive stakeholder engagement and clear documentation are essential to ensure that everyone remains on track and regulatory requirements are met. Successfully navigating these complexities is key to advancing products efficiently through the development pipeline.

What are CMC Program Managers?

CMC Program Managers are professionals responsible for overseeing the Chemistry, Manufacturing, and Controls (CMC) aspects of pharmaceutical or biotechnology product development. They coordinate cross-functional teams to ensure that drug development activities related to product formulation, manufacturing, quality, and regulatory submissions are completed on time and within budget. Their role is crucial in advancing products through clinical development to commercialization while ensuring compliance with global regulatory requirements.

What is the difference between Cmc Program Manager vs Cmc Project Manager?

AspectCmc Program ManagerCmc Project Manager
CredentialsTypically requires a Bachelor's degree in life sciences, engineering, or related field; often certifications like PMP or PgMPUsually holds a Bachelor's degree in a relevant field; PMP certification is common
Work EnvironmentOversees multiple projects within a program, coordinating cross-project activities in biotech or pharma industriesManages individual projects, focusing on specific deliverables within the CMC scope
Employer & IndustryPharmaceutical, biotech, or life sciences companies managing complex product developmentSimilar industry, often within the same companies, focusing on specific project execution

The Cmc Program Manager oversees multiple related projects, ensuring alignment with strategic goals, while the Cmc Project Manager focuses on executing individual projects within the CMC domain. Both roles require similar credentials and work in the same industry, but differ in scope and responsibilities.

What are popular job titles related to Cmc Program Manager jobs in Michigan? For Cmc Program Manager jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Cmc Program Manager jobs in Michigan look for? The top searched job categories for Cmc Program Manager jobs in Michigan are:
What cities in Michigan are hiring for Cmc Program Manager jobs? Cities in Michigan with the most Cmc Program Manager job openings:
Cmc Program Manager jobs near you
Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

Associate Director, CMC Regulatory Affairs (Hematology/Oncology)

Regeneron Pharmaceuticals

Warren, MI • Hybrid

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 15 days ago

Regeneron rating

8.7

Company rating: 8.7 out of 10

Based on 42 frontline employees who took The Breakroom Quiz

14th of 70 rated pharmaceutical

Job description

As an Associate Director you will lead the development and execution of global CMC regulatory strategies for the hematology and oncology portfolios. You will guide regulatory activities across development stages, mentor CMC Regulatory Affairs (RA) staff, supporting cross-functional and external partners, and serving as a key liaison in regulatory authority interactions.

For US locations, this role is on-site 4 days in the office and 1 day from home. For Uxbridge, UK or Dublin, Ireland this role would be on-site 3 days per week and 2 days from home. A fully remote role is not possible for this position . If eligible, we can offer relocation benefits.

A typical day may include the following:
Lead product development activities from a CMC regulatory standpoint with input from senior management.
Represent CMC RA at program meetings and independently provide regulatory interpretation, position, and covering clinical development, initial market applications, and approval/post-approval activities.
Identify program issues and develop appropriate regulatory strategies to mitigate risks to filings, independently find alternative solutions/work-arounds, and obtain consensus.
Critically review and provide meaningful and strategic input on regulatory filing documents (e.g., INDs, IMPDs, meeting packages, scientific advice, BLAs, MAAs, BPDRs, annual reports, DSUR, amendments, supplements) to facilitate and expedite the development, licensure, and marketing of drugs and/or biologics.
Lead and facilitate interactions with global regulatory authorities (e.g., meetings, IR responses, inspections).
Perform final review and approval of the compliance activities of the portfolios to confirm regulatory impact and associated submission requirements for clinical and commercial regulatory filings in accordance with country-specific regulatory guidance documents;
Mentor colleagues in difficult compliance assessment discussions with SMEs or Senior Management; find opportunities for improvement of processes for compliance tasks.
Develop and create working instructions, SOPs, and/or templates to facilitate consistent and efficient practice across the CMC RA groups.
Identify gaps in the IOPS and global RA processes, bring up to higher management, and help to improve business efficiency.
Support establishing, managing, and maintaining a knowledge base of current and emerging regulatory requirements and guidelines in the CMC field.
Find opportunities to initiate operational changes and policy modifications.
Manage and coach team member(s).

This may be for you if you:
Have a strong grasp of CMC worldwide regulations and guidelines.
Have been successful in building collaboration and teamwork across cross-functional teams.
Can demonstrate a proven track record managing and mentoring people.
Demonstrated skill in managing multiple priorities.


To be considered a bachelor's degree with a minimum of 10 years of pharmaceutical/biotech industry experience, including 5+ years of relevant CMC experience. An advanced degree is preferred. Proven track record supporting biological products through development and approval is a distinct advantage. It is required to have a good understanding of current CMC worldwide regulations and guidelines. Experience in interacting with the US FDA and other regulatory authorities. Experience with device regulatory requirements and development processes for combination products is a plus.

Does this sound like you? Apply now to take your first step towards living the Regeneron Way! We have an inclusive culture that provides comprehensive benefits, which vary by location. In the U.S., benefits may include health and wellness programs (including medical, dental, vision, life, and disability insurance), fitness centers, 401(k) company match, family support benefits, equity awards, annual bonuses, paid time off, and paid leaves (e.g., military and parental leave) for eligible employees at all levels! For additional information about Regeneron benefits in the US, please visit https://careers.regeneron.com/en/working-at-regeneron/total-rewards/. For other countries' specific benefits, please speak to your recruiter.
Please be advised that at Regeneron, we believe we are most successful and work best when we are together. For that reason, many of Regeneron's roles are required to be performed on-site. Please speak with your recruiter and hiring manager for more information about Regeneron's on-site policy and expectations for your role and your location.

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.

Salary Range (annually)

$157,200.00 - $256,600.00

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