Regulatory Affairs Specialist (Contract)

Oct 13, 2021

Job Description

20+! This is the number of submissions that you will oversee for the countries you will be managing.

Your responsibilities include, but not limited to:
• Ensure submission for product registrations or variations are carried out in a timely manner in compliance with internal and external regulatory requirements.
• Liaise with local regulatory authorities and Regional Regulatory Affairs to deliver timely and commercially advantageous license approvals.
• Initiate and coordinate licence amendment (e.g. production transfer, CMC update, PI update, etc.) submissions and approvals with relevant documents and supporting data from Regional Regulatory Affairs.
• Manage labelling text and packaging components to ensure compliance with local registered details and corporate prescribing information, as well as maximising the commercial value of the label. Obtain all relevant Import/Export Licences. Ensure compliance with local, regional and corporate regulatory SOP’s and other processes.
• Responsible for the oversight of the regulatory compliance of medical devices. Providing input into the global regulatory strategy and identifying country specific requirements for successful regulatory filings for new medical devices/ products including life cycle management and renewals where required.
• Involves in overall quality responsibility and executing activities in accordance with the Quality Management System, engagements to the local launch processes to ensure imported products are launched on schedule and in compliance with regulatory, Malaysia GDPMD, safety, health and environmental and corporate quality standards from medical device registration, importation through to commercialization and distribution.
• Manage to maintain all local marketed products in compliance with local and corporate regulatory requirements. Maintaining labelling documentation and providing access for CMO&PS to PV Share folder, including filing of required variations, and informing CMO&PS of received approvals.
• Ensuring CMO&PS are informed, of all Post Authorisation Safety studies (PASS), registries, marketing/marketing research programs, POPs, Social Media Programs, Market Access/ Compassionate Use programs conducted in the Territory. The name of the Responsible Person(s) (including address, telephone and fax number) responsible for ensuring CMO&PS are notified of this information in the Territory for the MAH/CT Sponsor is set out in Appendix 1 hereto.

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

Job Requirements:
• 2-3 years of experience in Regulatory Affairs within the Pharmaceutical industry.
• Pharmacy degree and a Pharmacist registered with the Singapore Pharmacy Board is a must.
• Has understanding of Regulatory guidelines, quality, standards and policies.
• Has strong negotiation and analytical skills
• Able to understand changing dynamics of Pharmaceutical industry Regulatory Submissions.
• Able to work under pressure and flexible in a dynamic environment.
• Good proficiency in Microsoft Office

Why Sandoz?
500 million patients were touched by Sandoz generic and biosimilar medicines in 2020 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.

How will we do this? 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 Sandoz!
Commercial OPS SIR SZ
Research & Development
Full Time
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Regulatory Affairs Specialist (Contract)

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