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J&J Family of Companies
Columbus
Senior Regulatory Affairs Specialist - 2406193618W **Description** Abiomed, part of Johnson & Johnson's MedTech, is recruiting for a Senior Regulatory Affairs Specialist. _Remote work options may be considered on a case-by-case basis and if approved by the Company_ Abiomed, part of Johnson & Johnson MedTech, is a leading provider of medical devices
Job Source: J&J Family of CompaniesImbria Pharmaceuticals
Columbus, OH, United States
Company Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor
Job Source: Imbria PharmaceuticalsImbria Pharmaceuticals
Columbus, OH, United States
Company Overview Imbria Pharmaceuticals is a privately held, clinical stage company developing novel therapies for patients with life-altering cardiometabolic disorders. Our clinical programs are focused on restoring or improving the cells ability to produce energy in cardiovascular disorders where energetic impairment is a fundamental contributor
Job Source: Imbria PharmaceuticalsTakeda Pharmaceuticals
Columbus
By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Takeda’s Privacy Notice and Terms of Use . I further attest that all information I submit in my employment application is true to the best of my knowledge.
Job Source: Takeda PharmaceuticalsAlene Candles
New Albany, OH, United States
Who We Are Alene Candles LLC & Midwest is a private label, contract manufacturer that produces high-quality candles for some of the worlds most recognized retail, boutique, and cosmetic brands. With our headquarters in New Hampshire and additional locations in Ohio, weve been in business for over 25 years. We are passionate about making the best pr
Job Source: Alene CandlesAlene Candles
New Albany
Who We Are Alene Candles LLC & Midwest is a private label, contract manufacturer that produces high-quality candles for some of the world’s most recognized retail, boutique, and cosmetic brands. With our headquarters in New Hampshire and additional locations in Ohio, we’ve been in business for over 25 years. We are passionate about making the best
Job Source: Alene CandlesClean Team, Inc.
Columbus, OH, United States
Open Position for Site Manager in the Columbus, Ohio Area Full Job Description At Clean Team we take great pride in our work and strive to meet and exceed our clients' expectations. To get there, it takes outstanding, driven, and organized leaders to manage our accounts and coordinate team members. That's where you come in! As a Site Manager at
Job Source: Clean Team, Inc.Clean Team, Inc.
Columbus, OH, United States
Open Position for Site Manager in the Columbus, Ohio Area Full Job Description At Clean Team we take great pride in our work and strive to meet and exceed our clients' expectations. To get there, it takes outstanding, driven, and organized leaders to manage our accounts and coordinate team members. That's where you come in! As a Site Manager at
Job Source: Clean Team, Inc.New Albany
**HOW MIGHT YOU DEFY IMAGINATION?**
You’ve earned your degree. How will you use that achievement to reach your goals? Do more with the knowledge you’ve worked hard to acquire and the passion you already have. At Amgen, our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Become the professional you are meant to be in this meaningful role.
Regulatory Affairs Manager, CMC.
**Live**
**What you will do**
Let’s do this. Let’s change the world. In this vital role you will provide regulatory strategy for lifecycle management products. This position will be responsible for the strategy and execution of the site-specific aspects of the preparation of CMC investigational product amendments and post-market supplements, organization and preparation CMC sections of IND annual reports and annual reports of minor changes for specific products; acts as key RA CMC representative on product deviation investigation teams, participates in site change control teams
**Win**
**What we expect of you**
We are all different, yet we all use our unique contributions to serve patients. The Regulatory Affairs professional we seek is a leader with these qualifications.
+ Facilitate product development, global registration by developing and executing regulatory strategies and effective regulatory agency interactions for product manufacturing and quality programs throughout product lifecycle.
+ Provide CMC regulatory strategy for products manufactured at or planned for the specific site.
+ Interface with the site (R&D and operations authors) coordinate preparation of regulatory filings, identification of issues and factors that may implicate a regulatory strategy or activity.
+ Support Change Management activities
+ Monitor and, as necessary, provide data to be entered into tracking systems for department deliverables and ensure information is current.
**Basic Qualifications:**
+ Doctorate Degree Or
+ Master's Degree and 3 years of Regulatory CMC or related technical experience Or
+ Bachelor's Degree and 5 years of Regulatory CMC or related technical experience Or
+ Associates degree and 10 years of Regulatory CMC or related technical experience
**Preferred Qualifications:**
+ Regulatory CMC knowledge and experience
+ Experience in manufacture, testing (QC/QA, distribution, or clinical), process development or other related Pharmaceutical/Biotech industry
**Thrive**
**What you can expect of us**
As we work to develop treatments that take care of others, we also work to care for our teammates’ professional and personal growth and well-being.
Amgen offers a Total Rewards Plan comprising health and welfare plans for staff and eligible dependents, financial plans with opportunities to save towards retirement or other goals, work/life balance, and career development opportunities including:
+ Comprehensive employee benefits package, including a Retirement and Savings Plan with generous company contributions, group medical, dental and vision coverage, life and disability insurance, and flexible spending accounts.
+ A discretionary annual bonus program, or for field sales representatives, a sales-based incentive plan
+ Stock-based long-term incentives
+ Award-winning time-off plans and bi-annual company-wide shutdowns
+ Flexible work models, including remote work arrangements, where possible
**Apply now**
**for a career that defies imagination**
Objects in your future are closer than they appear. Join us.
**careers.amgen.com**
Amgen is an Equal Opportunity employer and will consider you without regard to your race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status.
We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment. Please contact us to request accommodation.
Email Alert for Regulatory Affairs Manager (CMC Site)_ jobs in New Albany
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