Associate Principal Scientist supporting regulatory strategies for Vaccine & Infectious Disease products. Collaborating globally and assisting submissions for regulatory compliance in the pharmaceutical industry.
About the role
- Principal Scientist overseeing Regulatory CMC strategies and submissions for pharmaceutical products in the Respiratory franchise. Collaborating with teams to ensure regulatory compliance and approval.
Responsibilities
- Provide regulatory leadership, oversight, and strategy to a team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions related to small molecule, development products.
- Lead oversight of multiple programs in Respiratory franchise and some conventional small molecule programs.
- Prepare applicable IND/CTA’s, Agency Background Packages, Worldwide Marketing Applications, and transfer strategy to post-approval group for further submissions occurring within several years post-launch in the major markets.
- Support a project in a similar capacity by providing direction to the team members that are responsible for developing and overseeing implementation of regulatory strategies.
- Assess CMC changes during development, defining regulatory requirements, developing CMC regulatory strategies, ensuring high quality, accuracy, and high likelihood of approval of all regulatory submissions.
- Develop, execute & provide oversight of regulatory initiatives & strategies of significant complexity.
Requirements
- Master’s degree in chemistry, Pharmacy, or a related discipline; post-graduate degree preferred.
- Minimum 15 years pharmaceutical industry experience; 10 years with an advanced degree.
- Minimum 5 years working in Regulatory CMC, including the development stages of the product life cycle, and a minimum of 3 years managing people.
- Regulatory CMC experience with drug-device combination products/ inhalation products including nebulizers, dry powder inhalers and metered dose inhalers is required.
- Comprehensive knowledge of the latest global regulatory guidance and pharmacopeial methods with a demonstrated ability to apply them to building regulatory strategies related to Inhalation products.
- A good understanding of characterization studies and key analytical methods used for inhalation products.
- Proficiency in English; additional language skills are a plus.
Benefits
- medical, dental, vision healthcare and other insurance benefits (for employee and family)
- retirement benefits, including 401(k)
- paid holidays
- vacation
- compassionate and sick days
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