This job has expired

Associate DRA Manager

Shanghai, China
Closing date
Jan 29, 2023

View more

Full Time
Organization Type
Jobseeker Type
You need to sign in or create an account to save a job.
Job Description

400 million! That's how many people worldwide cannot access essential health services and more than 2 billion cannot afford to buy the medicines they need. At Sandoz, we discover new ways to improve and extend people’s lives. We pioneer novel approaches to help people around the world access high-quality medicine.

Your Key Responsibilities:
Your responsibilities include, but not limited to:
• Initiate dossier preparation, request available regulatory documents from HQ and within Sandoz China (Scientific Affair, Clinical Affair, and Tech Op). Coordinate the patent search and confirm the administration and new drug protection in China
• Review registration dossiers, to ensure registration documentation to confirm the requires of NMPA
• Initiate and confirm translation of dossiers for all documents received into Mandarin (or into English) through project team review
• Ensure registration documentation, samples submission and process to related government department
• Be the key players in clearance and review of all promotional materials to ensure legitimacy of the materials.
• To be a specialist of Chinese drug regulatory and provide update information on regulatory requirements of NMPA
• To build relationships with officers and departments of NMPA to ensure approval procedure within set timelines.
• To be a good coordinator for 3rd researching company. To translate key technical documents on the registration dossiers

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

Minimum Requirements

• Minimum: University degree in the life sciences (medicine, Pharmacy, bio-sciences), a graduate degree in Pharmaceutics or Medicine
• Oral and written communication in English
• Board multi-functional experience in pharmaceutical development process and science, specifically in regulatory, clinical or chemistry

Why consider Sandoz?

Our number 1 priority is to pioneer patient access to better healthcare. We are a company of firsts. 1st to develop an oral penicillin antibiotic. 1st to develop and launch biosimilars. 1st to launch an FDA-cleared digital therapeutic. And we never stop asking: how can we continue to pioneer access in an ever-more digital and global world?

The answers come when curious, courageous and collaborative people are empowered to ask new questions, make bold decisions and take smart risks.

Sandoz, a Novartis division, is a leader in generic and biosimilar medicines and a pioneer in digital therapeutics.

Imagine what you could do at Sandoz!

Commitment to Diversity & Inclusion:

Sandoz, a Novartis company, embraces diversity, equal opportunity and inclusion. We are committed to building diverse teams, representative of the patients and communities we serve, and we strive to create an inclusive workplace that cultivates bold innovation through collaboration, and empowers our people to unleash their full potential.

Join our Novartis Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Novartis and our career opportunities, join the Novartis Network here:
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalized job recommendations straight to your inbox.

Create alert