Senior DRA Specialist

Sep 10, 2021
Hong Kong Special Administrative Region, China

Job Description

799 million. That's how many lives our products touched in 2019. And while we're proud of that fact, in this world of digital and technological transformation, we must also ask ourselves this: how can we continue to improve and extend even more people's lives?
We believe the answers are found when curious, courageous and collaborative people like you are brought together in an inspiring environment. Where you're given opportunities to explore the power of digital and data. Where you're empowered to risk failure by taking smart risks, and where you're surrounded by people who share your determination to tackle the world's toughest medical challenges.

Imagine what you could do at Novartis!

Major Accountabilities:

Regulatory Affairs
•Keep abreast of the local and global regulatory environment and execute assigned regulatory activities
•Preparation of documentations for regulatory submissions (including new product submissions, change in particulars, tender submissions) to authorities including HK Department of Health, Hospital Authority, or Macau MoH
•Maintain centralized databases on regulatory activities and update accordingly; perform regular follow ups on assigned products and tasks according to business priorities.
•Ensure proper filing and records keepings for regulatory documentations.
•Work closely with various internal departments and distributors in maintenance of product supply continuity and ensuring regulatory compliance in Hong Kong and Macau.
•Assist in departmental improvements and initiatives for corporate projects
•Handling and oversight of 3rd parties for commercial related issues
•Advice junior associates for work related issues when necessary; assist department head in mentoring when necessary

Minimum Requirements

What you'll bring to the role:
•3-5 years’ relevant working experience, candidates with more experience may be considered with a senior role
•Quality assurance / regulatory affairs experiences in pharmaceutical industry will be an definite advantage
•Degree holder in pharmacy, pharmaceutical Studies or other science related discipline
•Good team player with strong communication skills
•Self-motivated and fast learner
•Good command of English and Chinese
•Good knowledge of MS Office and Excel

Why Novartis?
769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.

We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.

We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!

Imagine what you could do here at Novartis!

Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Join our Novartis network: If this role is not suitable to your experience or career goals but
you wish to stay connected to hear more about Novartis and our career opportunities, follow us via Novartis Group WeChat Recruitment Account.
Commercial OPS SIR SZ
Hong Kong Special Administrative Region, China
Hong Kong
Research & Development
Full Time
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Senior DRA Specialist

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