- EU GMP requirements
- Must have Global Regulatory Affairs experience in the pharmaceutical or biotechnology industry.
- Growth Opportunities
- Great Pay
- Excellent work environment with growth opportunities
- Great Benefits
- Vacation Days
- Bachelor's degree required
- A minimum of 5 plus years Regulatory Affairs experience
- Previous working experience with preparation of (s)BLA/(s)NDA/MAA, INDs/CTAs.
- EU GMP requirements
- Must have Global Regulatory Affairs experience in the pharmaceutical or biotechnology industry.
- End-to-end regulatory submission and document management experience.
- Support internal policy reviews for global regulatory guidance and regulations
- Regulatory Strategy: Develop and execute regulatory strategies to achieve successful product registration and commercialization.
- Identify improvements and efficiencies to Regulatory Affairs.
- Compliance Expertise: Provide expert guidance on specific controls, ensuring adherence to cGMP (current Good Manufacturing Practice) and other relevant standards.
- Cross-Functional Collaboration: Work closely with cross-functional teams to integrate regulatory requirements into manufacturing processes.
- Regulatory Representation: Represent the company in interactions with regulatory authorities, leading discussions as needed.
- Product Support: Provide regulatory affairs support for sustaining products, including assessments and change management.
- Surveillance and Analysis: Engage in regulatory surveillance activities and provide regular analysis to support existing and future processes.
- Demonstrated good leadership skills
- Excellent verbal and written skills
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Manager Global Regulatory Affairs - Princeton, United States - Ajulia Executive Search
Description
Manager Global Regulatory Affairs
Princeton, New Jersey
Are you looking to make a career change to a stable company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical insurance, dental insurance, vision insurance and paid PTO.Does this position match your future career goals? Then this opportunity could be the right fit for you.
Why should you apply?
Essential Requirements and Duties:
Jasleen Kaur
Ajulia Executive Search is a search firm specializing in Manufacturing, Finance, IT, Legal and Pharmaceutical positions. This is a confidential search for one of our preferred clients. It is a direct hire position that includes competitive compensation and full comprehensive benefit package.
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