Top 39 Pharmaceutical manufacturing Jobs in Ann Arbor Mi

Senior Regulatory Affairs Specialist -FDA Medical, Cosmetics, Dietary Supplements
Wacker Chemie AG —Ann Arbor, MI
- Online Application
- Bachelor of Science
- Office
- Master's degree
- Paid parental leave
- Paid holidays
Part Time Service Technician (Canton, MI)
Innovative Refrigeration Systems —Canton, MI
- $25 - $30 an hour
- Part-time
- Heavy lifting
- Pass drug screening
- High school diploma or GED
- Flexible schedule
Quick Apply
Logistics Coordinator
Johnson Controls —Farmington Hills, MI
- $26.92 - $37.01 an hour
- Full-time
- Background check
- Mid-level
- High school diploma or GED
- Paid training
- Wellness program
Production Associate Shift Premiums Available (Day, Afternoon & Night Openings Available)
Biovire —Brighton, MI
- $20 - $22 an hour
- Full-time
- English
- High school diploma or GED
- Ability to lift 50 pounds
- Disability insurance
- Health insurance
Quick Apply
Assembly Coordinator
Piab Group —Canton, MI
- Data analysis skills
- Mid-level
- 3 years
- Opportunities for advancement
10d
Production Technician (ALL SHIFTS AVAILABLE)
Biovire —Brighton, MI
- Full-time
- Mid-level
- High school diploma or GED
- Bachelor's degree
- Paid training
- Disability insurance
Quick Apply
4d
Exec Director, Drug Substance Development & Manufacturing
ESPERION THERAPEUTICS INC —Ann Arbor, MI
- $320,500 - $365,000 a year
- Full-time
- Remote
- Bachelor of Science
- 8 years
- Bachelor's degree
- Paid holidays
- Health insurance
Quick Apply
Quality Control Technician
Jogue, Inc. —Plymouth, MI
- $20 - $23 an hour
- Full-time
- Background check
- Basic math
- Mid-level
- Health insurance
- Dental insurance
Quick Apply
13d
Supplier Quality Engineer
Katalyst Healthcares & Life Sciences —Dexter, MI
- Contract
- Engineering
- ERP systems
- 8 years
Quick Apply
Warehouse Associate – Materials & Logistics
Biovire —Brighton, MI
- Full-time
- Forklift
- Ability to lift 50 pounds
- Warehouse experience
- Disability insurance
- Health insurance
Quick Apply
Program Manager, Strategy & Business Development
BIRDI, INC —Plymouth, MI
- Remote
- Microsoft Excel
- Microsoft Outlook
- 5 years
Quick Apply
Pharmacy Technician
Corewell Health —Farmington Hills, MI
- Part-time
- High school diploma or GED
- Manufacturing
- Entry level
Calibration Lead
Biovire —Brighton, MI
- Full-time
- 5 years
- High school diploma or GED
- Mentoring
- Disability insurance
- Health insurance
Quick Apply
Fire Detection Inspector
Johnson Controls —Farmington Hills, MI
- $19.13 - $26.35 an hour
- Weekends as needed
- Clean driving record
- Microsoft Outlook
- Computer literacy
- Paid training
- Wellness program
Controls Engineer
Daniels Health —Ann Arbor, MI
- $99,395 - $115,395 a year
- Full-time
- Hybrid work
- Mid-level
- Continuous improvement
- Travel
- Health insurance
- Dental insurance
Quick Apply
NDE Assistant
Diamond Technical Services —Livonia, MI
- Part-time
- High school diploma or GED
- Ability to lift 50 pounds
- Driver's License
- Health insurance
- Dental insurance
13d
Validation Engineer
BWI Chassis Dynamics (NA) Inc. —Brighton, MI
- Email
- Microsoft Outlook
- Computer literacy
- English
Quick Apply
Senior Controls Engineer
Daniels Health —Ann Arbor, MI
- $125,375 - $141,079 a year
- Full-time
- Hybrid work
- 8 years
- Continuous improvement
- Travel
- Health insurance
- Dental insurance
Quick Apply
Head of Validation
Biovire —Brighton, MI
- Full-time
- Management
- 5 years
- Engineering
- Disability insurance
- Health insurance
Quick Apply
RT/CRT Technician
Diamond Technical Services —Livonia, MI
- $180 a day
- Weekends as needed
- Mid-level
- Travel
- Communication skills
- Disability insurance
- Dental insurance

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Senior Regulatory Affairs Specialist -FDA Medical, Cosmetics, Dietary Supplements

Wacker Chemie AG -
Ann Arbor, MI

Apply Now

Job Details

Benefits

Paid parental leave
Paid holidays
Health insurance
Dental insurance
Paid time off
Parental leave
Vision insurance
401(k) matching
Opportunities for advancement

Qualifications

Legal analysis
Drug regulation
Bachelor's degree
Biomedical regulatory compliance
Cross-functional collaboration
Cross-functional communication

Full Job Description

Job Title: Senior Regulatory Affairs Specialist -FDA Medical, Cosmetics, Dietary Supplements
Job Location (Short): Ann Arbor, MI, USA, 48108

Posting Start Date: 6/19/26

Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future.

To strengthen our team in Ann Arbor ,
we are looking for you as a(n) Senior Regulatory Affairs Specialist -FDA Medical, Cosmetics, Dietary Supplements .

Senior Regulatory Affairs Specialist-FDA Medical

Responsible for managing Wacker Chemical Corporation’s corporate compliance program for Medical and Drug applications per the requirements of the 21 CFR regulations
Responsible for refining Wacker’s corporate procedures and strategy regarding FDA compliance toward medical device components, drugs, ad healthcare applications.
Evaluates and responds to incoming internal and external customer product compliance requests and will review and access the chemical composition of Wacker product formulas and incoming raw material chemicals used in medical device, drug, and healthcare applications such as wound care
Prepars and submits forms and applications for Wacker FDA Drug and Device Master Files. Prepare portions of Drug Master File (DMF) packages, establishing project work as needed with outside consultation and preparing and submitting Medical Device Master File (MAF) packages and updates.
Experience in Natural Health Products, as well as in the process for filing new drug ingredient notifications and the technical data required by the agency, even if the customer is doing the actual filing.
Awareness of drug facility registration requirements would be useful. For medical devices, working knowledge of biocompatibility testing (USP Class VI & ISO 10993) and their applicability to different types of products.
Recognition of the differences between US and Canadian regulations. Familiarity with Canadian Medical Device regulations, Drug regulations, and Cosmetic regulations and serving as the liaison between Wacker and our Canadian Regulatory Agent
Work with other departments to ensure compliance to Good Manufacturing (GMP), FDA-CFR, ISO, Responsible Care standards and regulations.
Will interpret FDA regulations and utilizing government and 3rd party databases such as the FDA Electronic Submission Gateway (ESG). Familiarity with appropriate FDA cGMP or other applicable guidance such as the USP Good Manufacturing Processes for Bulk Pharmaceutical Excipients and FDA Active Pharmaceutical Ingredient (API) regulatory approval process.

Requirements :

Bachelor of Science Degree in Biology, Chemistry, Toxicology, or Pharmacology. Master's Degree is preferred.
7+ years of experience preferred.
Strong organizational and professional skills with extensive knowledge of FDA regulations and reading and interpreting legal documents.
Knowledge and experience in 21 CFR regulations on Drugs (API, OTC, Excipient), Veterinary products, Medical Devices, and products which can cross categories, like transdermal patches.
Strong leadership, interpersonal and problem-solving skills.
Experience working in cross-functional teams.
Experience working with leadership and team members to ensure a safety, quality and environmentally conscience culture.
Experience in polymer chemistry is preferred.

What do we offer?

WACKER is an equal opportunity employer committed to diversity, equity, inclusion, and sustainability. We are innovators, researchers, and pioneers and we believe that our individual differences are our collective strength. We foster an inclusive environment that promotes individuality, celebrates diversity, and builds cohesive teams. Together, we create exceptional value for our employees, our customers, and our communities by creating a culture of inclusion and equity that enables, empowers, and values our diverse contributions.

WACKER strives to reward its employees in a fair and equitable manner. Our Total Rewards Package considers employee wellbeing and is comprised of compensation, benefits, work-life balance, performance & recognition, and career development.

Compensation and Incentive plans
Medical, Dental, and Vision Insurance effective day 1
Paid Time Off in addition to personal days and holidays
Paid parental leave
Wellbeing fund
Flexible hybrid work arrangements
401(k) with company match
Education Assistance Program
Career development and advancement opportunities
Support for Community Involvement

We are looking forward to your online application at www.wacker.com.
Reference Code: 31073
#LI-LGI
The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job.
A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis. Visa sponsorship is not available for this position, including for any type of US permanent residency (e.g., for a green card).
WACKER is proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.
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Refine Your Search

pharmaceutical manufacturing jobs in ann arbor mi

Senior Regulatory Affairs Specialist -FDA Medical, Cosmetics, Dietary Supplements

Part Time Service Technician (Canton, MI)

Logistics Coordinator

Production Associate Shift Premiums Available (Day, Afternoon & Night Openings Available)

Assembly Coordinator

Production Technician (ALL SHIFTS AVAILABLE)

Exec Director, Drug Substance Development & Manufacturing

Quality Control Technician

Supplier Quality Engineer

Warehouse Associate – Materials & Logistics

Program Manager, Strategy & Business Development

Pharmacy Technician

Calibration Lead

Fire Detection Inspector

Controls Engineer

NDE Assistant

Validation Engineer

Senior Controls Engineer

Head of Validation

RT/CRT Technician

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