Asia Regulatory Affairs Associate Manager (6 months contract)
Salary undisclosed
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iNova was certified as a Best Place to Work in 2021. We are innovative, motivated, and passionately solution focused to support our customers in leading a healthy lifestyle. Join the team to experience the reasons why people love working for us!
The Opportunity
We currently have an opportunity for an experienced Asia Regulatory Affairs Associate Manager, to join our Asia Regional Regulatory team on a 6 months contract basis.
Reporting to the Asia Regulatory Affairs Associate Director, the primary purpose of this position is to support strategic and tactical Asia regulatory operational activities and maintain regulatory compliance of iNova’s existing and new products throughout Asia.
Key Accountabilities & Performance Indicators Includes
iNova has a diverse portfolio of iconic brands across 20 countries including Australia & New Zealand, Asia and Africa and a dedicated team who put people's health first every day. With our unique blend of leadership and empowerment, we are just that little bit different and are proud of who we are.
Benefits
We know our people perform their best when they are happy and healthy at work, so we offer a range of benefits including:
If you wish to be part of an energetic team within a thriving organisation, focused on bringing innovative products to market, please APPLY TODAY! We want you to join us in our pursuit of healthy living!
The Opportunity
We currently have an opportunity for an experienced Asia Regulatory Affairs Associate Manager, to join our Asia Regional Regulatory team on a 6 months contract basis.
Reporting to the Asia Regulatory Affairs Associate Director, the primary purpose of this position is to support strategic and tactical Asia regulatory operational activities and maintain regulatory compliance of iNova’s existing and new products throughout Asia.
Key Accountabilities & Performance Indicators Includes
- Regulatory Project Management
- Strategically project manage the collation of submission documents, submissions, responses to regulatory authority questions and approvals for new products and product variations across Asia
- Support the planning and execution of submission strategies for regulatory submissions in Singapore and across Asia, to maximise the likelihood of regulatory approval and speed to market
- Interface with key functional groups (in-country Regulatory Affairs (RA) teams, Regional and Group RA, Technical Operations, Quality, Supply Chain, Marketing, Legal, IT, Innovation and Business Development (BD)) to drive Singapore’s, regional or cross-departmental initiatives, providing quality and timeliness of regulatory inputs into cross-functional teams
- Support Regulatory Operational Activities
- Support submissions and approvals for new product registrations, renewals, variations and maintenance of registered products in Singapore
- Responsible for providing input and approval on advertising/promotional materials for regulatory compliance.
- Serve as the key internal regulatory liaison for Asian in-country RA teams and iNova’s distributors throughout Asia
- Support the development and implementation of regulatory procedures and processes to promote harmonisation and standardisation, where practicable, and ensure operational efficiency and effectiveness across Asia
- Adopts and assures alignment of iNova’s regulatory information management system with other organizational systems
- Minimum 4-5 years’ pharmaceutical industry experience in Singapore and Asia region. (Essential)
- Pharmacy, medical or relevant science degree with good pharmacological/ pharmaceutical chemistry/ clinical knowledge (Essential)
- Familiar with regulatory framework in Singapore, ASEAN, China, Taiwan, Korea, Japan and/or India (Desirable)
- Experience in working in regional regulatory affairs in a multinational pharmaceutical company (Desirable)
- Post-graduate degree in Life Sciences. (Desirable)
- Familiar with fundamental principles of clinical, regulatory, registration and compliance issues in Asia Pacific and how those regulations impact on the development, introduction, manufacture, quality, registration and marketing of pharmaceutical products, food, health supplements, herbal medicines medical devices and/ or cosmetic products.
- Strong project planning and organisational skills and a high degree of multi-project tasking; ability to handle multiple projects within an active and wide range of health care products portfolio.
- Demonstrate strong interpersonal, communication, influencing and engagement skills.
- Ability to work independently, actively participate as a team member and act as mentor to junior team members
- High attention to detail and accuracy.
- Influencing and interpersonal skills; proven decision-maker, hands-on and action-oriented style.
- Strong communication skills (both oral and written), technical writing capabilities preferred.
- Self-motivated, flexible & creative leader, able to prioritize, multi-task and work in a fast-paced and demanding environment.
- Positive flexible outlook.
- Presents professional manner and appearance.
- Adhere to company values at all times
iNova has a diverse portfolio of iconic brands across 20 countries including Australia & New Zealand, Asia and Africa and a dedicated team who put people's health first every day. With our unique blend of leadership and empowerment, we are just that little bit different and are proud of who we are.
Benefits
We know our people perform their best when they are happy and healthy at work, so we offer a range of benefits including:
- Hybrid working arrangements
- Health and wellness initiatives
- A thriving awards and recognition program
- And a day off for your birthday!
If you wish to be part of an energetic team within a thriving organisation, focused on bringing innovative products to market, please APPLY TODAY! We want you to join us in our pursuit of healthy living!
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