-  Het slimme netwerk waarop hbo‑ en wo‑studenten hun baan of stage vinden.

Het slimme netwerk waarop hbo‑ en wo‑studenten hun baan of stage vinden.

Senior Regulatory Affairs Manager

Geplaatst 15 mei. 2024
2 tot 3 jaar
Full-time / part-time
Soort opleiding
Engels (Vloeiend)

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Key Responsibilities:• Provide regulatory inputs in new project development strategy discussion;• Lead or coordinate both local and global team on registration plan;• Be accountable on the implementation the decided project registration strategy by projects planning and tracking; Be accountable on achieving the target timeline of submission and approval; Be accountable on the communication with HAs to properly address the concerns on projects; and the coordination on related HA meetings; Be accountable on the communication with Global team on the related regulatory issues on the responsible projects; Be accountable for ensuring regulatory compliance for the responsible brands like CMC, BPI,PSUR, RMP, registration master file and timely update in DRAGON;• To solve the regulatory issues via communication and negotiation with HAs if necessary; Review/approve of promotional materials and press releases for NP4 Managerial (MCC review);• Lead or chair the CPT meetings for responsible project and be accountable to provide regulatory support to other functional team;• Contribute to optimize DRA internal operational procedures whenever is needed. Ensure regulatory activities comply with Novartis internal Code of Conduct and SOPs/WIs during routine work; Monitor regulatory changes and report to department head timely; Support line manager to control project cost according to budget; Coach the junior levels ;• Acting as deputy in the absence of the department head and lead team daily operationCommitment to Diversity and Inclusion / EEO: Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.Essential Requirements: • At least 4 years in RA and/or drug/biologic; Development which include 2-3 years and above of demonstrated accomplishment in RA filed;• The experience in filing global trial CTA independently;• The experience in filing and obtaining NDA approval;• The experience in various types of regulatory submission/approvals;Desirable Requirements: • Bachelor or above with Pharmaceutical/Medical background;• Fluency in English and Chinese (oral and written).Why Novartis: Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together? and Rewards: Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: and Accommodation:Novartis is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the recruitment process, or in order to perform the essential functions of a position, please send an e-mail to and let us know the nature of your request and your contact information. Please include the job requisition number in your message.Join our Novartis Network: Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: You can follow us via Novartis Recruitment WeChat Official Account and Novartis Recruitment WeChat Video Account.

Our purpose is to reimagine medicine to improve and extend people's lives. We use innovative science and technology to address some of society's most challenging healthcare issues. We discover and develop breakthrough treatments and find new ways to deliver them to as many people as possible. We also aim to reward those who invest their money, time and ideas in our company.

Actief in 80 landen
300 medewerkers
40% mannen - 60% vrouwen
Gemiddeld 40 jaar oud