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Cmc Regulatory Affairs Senior Associate
Il y a 3 mois
At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Key Responsibilities:
Regulatory Strategy:
- Contributes to the development/implementation of global regulatory strategies and dossier plans for development compounds and marketed products according to scientific and riskbased principles
- Participates on CMC teams and represents CMC RA by providing regulatory expertise on the CMC teams and global regulatory teams
- Ensures CMC regulatory strategy is aligned with strategies of global regulatory affairs, therapeutic areas, and commercial regional functions
- Assures connectivity to the overall global regulatory strategy through partnership and communication with Therapeutic Area Regulatory Affairs or other seniorlevel colleagues
- Assists in the execution or development of contingency plans for issues that affect registration, regulatory compliance, and continued lifecycle management of the product
- Conducts Regulatory assessments for CMC change controls
Submissions:
- Works with the CMC teams and other CMC RA staff to prepare regulatory dossiers for submissions to Health Authorities (NDA/BLA/IND/CTA/postapproval changes)
- Coordinates, compiles, and manages CMC countryspecific documents required as part of the approval process for global submissions
- Coordinates, compiles and manage, including following up, on CMC dossiers
Health Authority Interactions:
- Prepares CMC Health Authority responses as needed according to the proposed strategy
- Provides CMC regulatory support to Health Authority inspections.
Others:
- Drives a culture of continuous improvement to ensure compliance with Johnson and Johnson standards regulatory requirements and expectations
- May participate in selected initiatives within CMC-RA or Global Regulatory Affairs
Qualifications:
Requirements:
- Bachelor of Science in engineering, biological, pharmaceutical, or chemical sciences with min 6 years of proven experience (inclusive postgraduate education and/or pharmaceutical or healthcare industry) is required
- Master in Science or equivalent experience, Ph.
- A solid understanding of pharmacy, biology, chemistry, and/or engineering is required
- Good verbal and written communication skills, good organizational skills, and strong attention to detail are required
- A solid understanding of global Health Authority laws, regulations, and guidance is a strong benefit
- Demonstrate the ability to communicate regulatory requirements present and defend CMCapproved regulatory strategy and opinion to the project team
- Prior experience in drug development, analytical development, or manufacturing is an asset
Johnson & Johnson Family of Companies are equal opportunity employers and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
