Regulatory Affairs Associate, Malaysia

4 months ago

Kuala Lumpur, Malaysia iNova Pharmaceuticals Full time

**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 Regulatory Affairs Associate, Malaysia & Brunei, to join our Regulatory Affairs team on a full-time basis.

Reporting to the Regulatory Affairs Manager, Malaysia and Brunei, the primary purpose of this position is to support the Regulatory Affairs Manager and work closely with other stakeholders in Malaysia and cross regionally to support the delivery of iNova’s commercial objectives to achieve timely approvals for new products while ensuring regulatory compliance of existing products.
- Key accountabilities include:_
- **Execution of Regulatory Activities**
- Familiar with pharmaceutical product regulations and guidelines, and responsible for the implementation of and compliance with regulatory requirements in Malaysia and Brunei (through a distributor)
- Familiar with regulations and guidelines for cosmetics, foods, medical devices, health supplements and herbal/ traditional medicines in Malaysia and Brunei
- Execute product registrations in line with company strategy to ensure compliance with local regulatory and company requirements
- Ensure ongoing compliance and maintenance of product registrations to meet regulatory and business obligations
- Work closely with local regulatory authorities to ensure a high level of current regulatory knowledge is maintained regarding product registrations and variations, as applicable
- **Execution of Pharmacovigilance Activities**
- Familiar with current Pharmacovigilance Guideline and requirement. Assist RA Manager in reporting of Adverse Drug Reactions (ADRs) and Adverse Events (AEs) in Malaysia and Brunei (through a distributor), in accordance with the company’s SOPs and local regulatory requirements.
- **Execution of Local Quality Assurance Activities**
- Ensure compliance with local regulatory requirements, any other applicable statutory requirements and any company requirements/ standards
- Work closely with RA Manager, Group QA and relevant functional department(s) to ensure outsourced activities are controlled and monitored within the scope of GxP
- Manage local complaints and recalls processes with support from Group QA and relevant distributors
- Approve product labels or artworks for production
- Approve repack and relabel instructions for products

**About You**

To be successful in this role, you will possess a Bachelor’s degree in an appropriate Science or Pharmacy discipline or post-graduate degree in Science is desirable with a minimum of 3 years’ in pharmaceutical industry and familiar with pharmaceutical regulations in Malaysia, and preferably in Brunei
- Other key requirements for this role include: _
- Experience in working with medical devices, herbal/ natural medicines, dietary supplements, cosmetics and food products
- Capable of prioritising projects, meeting deadlines and working well under pressure
- Demonstrated communication skills (both oral and written), technical writing capabilities preferred
- Able to interact with internal and external stakeholders in a professional manner
- Able to work independently and actively participate as a team member
- Demonstrated tenacity and adaptability to work and thrive in a VUCA environment

**Additional Requirements / Working Conditions**
- Adhere to company values at all times

**The Company**
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.

**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**

**How to Apply**
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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