(Senior) Drug Regulatory Affairs Officer
Novartis Pharmaceuticals (HK) Ltd
- Company Industries：Medical/Pharmaceutical
Job Information
- Post Date：2022-06-16
- Location：Ngau Tau Kok
- Employment Type：Degree
- Job Function：Medical Services Specialist Others Pharmaceutical
- Benefits：Double pay, Free shuttle bus, Life insurance, Medical insurance, Performance bonus, Work from home, Five-day work week, Flexible
Job Description
Responsibilities:
- Drug Regulatory Expertise:
- Utilize scientific information and work proactively to optimize drug product registration.
- Recognize scientific issues as relevant to project, and create awareness and communicate issues to the team.
- Regulatory Communication and Negotiation:
- Understand routine/basic health authorities' requirements and their operation.
- Communicate with health authorities and report on progress to superior.
- Communicate and negotiate with peers on regulatory strategies and operational issues.
- Operational Excellence:
- Use appropriate databases to complete job activities and archives.
- Regulatory Science:
- Understand the importance and relative priority of submissions to health authorities.
- Apply laws, regulation and guidelines to ensure compliance.
- Commercial Awareness:
- Recognize basic business, commercial and economic terms.
- Understand the commercial impact of delays in product introduction and/or change to the product label.
- Science and Technology for DRA:
- Understand scientific terminology and general drug development.
- Able to follow scientific presentations in order to complete job activities.
- Understand scientific discussions and be able to report content of discussion effectively.
- Degree or equivalent in Life Sciences, Pharmacy or Medicine
- Fluent in written and spoken English and Chinese
- 2-4 years’ experience in pharmaceutical industry
- Hands on experience in handling clinical technical dossiers, drug safety and medical data
- A broad understand of biomedical/pharmaceutical sciences
- Familiar with medical terminology and working with large databases
- Analytical, and ability to mitigate risk
You’ll receive:
Competitive salary, health and life insurance, flexible working arrangements. Find out more about Novartis: https://www.novartis.com/
Join us and help us reimagine medicine.
Novartis are an equal opportunities employer and welcome applications from all suitably qualified applicants
Company Info
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!
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!
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