CMCPM Radiopharmaceuticals
Eli Lilly and CompanySalary not specified
Full Time
Senior (5 to 8 years), Expert & Leadership (9+ years)
Not SpecifiedCompensation
Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level
Full TimeJob Type
UnknownVisa
Pharmaceuticals, HealthcareIndustries
Requirements
- Bachelor's degree in Pharmacy, Biology, Chemistry, Pharmacology, or a related field; Master’s degree preferred
- Minimum 7 years experience in Emerging markets regulatory preferably with a Multinational Company
- Strong expertise in CMC regulatory strategy, dossier evaluation, CMC remediations and product registration across emerging markets
- Proven ability to manage complex regulatory projects with minimal supervision and cross-functional collaboration
- Preferred Qualifications
- Recent experience on CMC in the emerging markets
- Led tech-transfer activities
- Cross-regional experience
Responsibilities
- Lead CMC regulatory strategy for product localization, remediation, and technical transfers involving formulation
- Act as CMC submission lead throughout the product lifecycle, ensuring compliance through regulatory filings and post-approval variations
- Support due diligence
Skills
CMC regulatory strategy
product localization
remediation
technical transfers
formulation
regulatory filings
post-approval variations
due diligence
dossier evaluation
product registration
cross-functional collaboration
Abbott
Healthcare solutions in diagnostics and devices
About Abbott
Abbott Laboratories focuses on improving health through various medical technologies and health solutions. The company operates in areas such as cardiovascular health, diabetes management, diagnostic testing, nutrition, and neuromodulation for chronic pain and movement disorders. Abbott's products include advanced medical devices and diagnostic tests that help healthcare professionals and patients manage health conditions effectively. For example, their cardiovascular technologies assist in heart health management, while diabetes care products enable accurate glucose monitoring without painful fingersticks. Unlike many competitors, Abbott emphasizes accessibility and affordability in its offerings, aiming to make life-changing technologies available to a broader audience. The company's goal is to positively impact global health and well-being, supported by a commitment to sustainability and a 2030 Sustainability Plan.
Lake Bluff, IllinoisHeadquarters
1888Year Founded
IPOCompany Stage
HealthcareIndustries
10,001+Employees
Risks
Departure of key leader Dr. Adamson may affect Abbott's Heart Failure division.
Integration challenges with Medtronic could impact glucose monitor-insulin pump rollout.
Thermo Fisher's microfluidics expansion may increase competition for Abbott.
Differentiation
Abbott integrates continuous glucose monitoring with automated insulin delivery systems.
Abbott's microfluidic devices streamline diagnostic processes efficiently.
Abbott's neuromodulation products target specific nervous system areas for chronic pain relief.
Upsides
Microfluidic technology offers cost-effective solutions in diagnostics.
Strategic partnerships like Abbott-Medtronic enhance product offerings and market reach.
Significant investments indicate strong market confidence in Abbott's healthcare solutions.
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