Regulatory Affairs Associate, Malaysia

5 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

  • Junior Regulatory Affairs, Quality Assurance

    5 months ago

    Kuala Lumpur, Malaysia Agensi Pekerjaan Permit Pro Consultancy Sdn Bhd Full time

    **Job Summary**: As a Junior Regulatory Affairs, Quality Assurance & Compliance Executive, you will play a crucial role in supporting regulatory processes, ensuring compliance, and maintaining product quality within the specified regions of Malaysia, Philippines, Vietnam, Singapore, Cambodia, Laos, and Myanmar. This role involves assisting with product...

  • Regulatory Affairs Manager

    5 months ago

    Kuala Lumpur, Malaysia BI (Malaysia) Sdn. Bhd Full time

    **The Position**: - To achieve timely & successful product registrations in accordance with corporate & local strategies. - To update the Company on new Regulations and Guidelines, and to ensure the Company complies with the local legislations & industry codes governing the import and control of therapeutic products. - To ensure compliance with Company...

  • Executive, Regulatory Affairs

    7 months ago

    Kuala Lumpur, Malaysia DKSH Full time

    **Location**:Kuala Lumpur, MY, MY**Job Summary** Supervise the execution of company quality assurance (QA), safety, health & environmental (SHE) and registration (REG) policies and standards, guarantee the regulatory compliance to local and international laws and regulations **General Responsibilities** - Support superior in managing day-to-day operating...

  • Regulatory Affairs Specialist

    2 months ago

    Kuala Lumpur, Malaysia Novonesis Full time

    **Location**: Malaysia : Kuala Lumpur **Country**: Malaysia**Our purpose points the way** In Novonesis, we know that solutions rooted in biology can help solve humanity’s biggest challenges. Since we began more than a century ago, this has been our guide. It’s how we've gotten so far. And it’s how we'll impact the future. Now, more than ever, the world...

  • Regulatory Affair Executive/manager

    5 months ago

    Kuala Lumpur, Malaysia NuFarm Full time

    Regulatory Affair Executive/ Manager Support Registration of Few Countries in SOUTHEAST Asia Grow a Better Tomorrow with Nufarm. Nufarm is the dependable partner behind thousands of agricultural success stories. Every day, growers around the world turn to our products and our people to help with the challenges of fighting disease, weeds, and pests, and...

  • Regulatory Affairs Specialist

    5 months ago

    Kuala Lumpur, Malaysia Zoll Medical Corporation Full time

    **Regulatory Affairs Specialist**: **Location: Remote, Remote**: **Circulation**: At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients...

  • Protégé - Regulatory Affairs

    7 months ago

    Kuala Lumpur, Malaysia Pfizer Full time

    The Regulatory Affairs Protege for GRS IRSP-Asia is responsible for assisting GRS-RSPI Asia in the preparation and submission of registration documents to Regulatory Authority and other administrative tasks. - Administrative Duties: Handle ad-hoc administrative tasks Records and documentation maintenance (filing, photostating, store maintenance, dispatch...

  • Regulatory Affairs Specialist

    5 months ago

    Kuala Lumpur, Malaysia ZOLL LifeVest Full time

    **Location: Remote, Remote**: **Circulation**: At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary...

  • Regulatory Affairs Executive

    5 months ago

    Kuala Lumpur, Malaysia The Estée Lauder Companies Full time

    The Regulatory Affairs Executive is responsible for ensuring that our products meet all legislative requirements. Key duties of the job include studying scientific and legal documents, gathering, evaluating, organising, managing and collating information in a variety of formats. **What You Will Achieve** - **Ensures Compliance**:Ensures all products meet...

  • Specialist, Regulatory Affairs

    5 months ago

    Kuala Lumpur, Malaysia Organon Full time

    **Responsibilities**: The Specialist is responsible for all PV and RA submission requirements and PV activities for their assigned product portfolio as applicable (medical device and pharmaceutical products. The Specialist collaborates with colleagues to ensure compliance with local laws and regulations, including backing up colleagues and adjusting...

  • Quality Assurance

    5 months ago

    Kuala Lumpur, Malaysia Recruit Express Full time

    **Principal Function** As a Quality Assurance (QA) and Regulatory Affairs (RA) Executive, you will play a key role in ensuring compliance with relevant regulatory requirements and maintaining the highest standards of quality across our organization. You will collaborate closely with cross-functional teams to implement and maintain quality management systems...

  • Quality Assurance

    5 months ago

    Kuala Lumpur, Malaysia Recruit Express Service Sdn Bhd Full time

    **Principal Function** As a Quality Assurance (QA) and Regulatory Affairs (RA) Executive, you will play a key role in ensuring compliance with relevant regulatory requirements and maintaining the highest standards of quality across our organization. You will collaborate closely with cross-functional teams to implement and maintain quality management systems...

  • Malaysia Associate Analyst

    5 months ago

    Kuala Lumpur, Malaysia BowerGroupAsia Full time

    Who We Are? BowerGroupAsia (BGA) is the premier government affairs, public policy and strategic communications advisory firm supporting the world’s leading multinational companies in the Indo-Pacific. With a presence in 25 countries, BGA staff provide bespoke services to clients in 28 markets across the region. We are a fast-growing company and seek a...

  • Malaysia Associate Director

    5 months ago

    Kuala Lumpur, Malaysia BowerGroupAsia Full time

    **Who We Are** BowerGroupAsia, Inc. (BGA) is the premier government affairs, public policy and strategic communications advisory firm supporting the world’s leading multinational companies in the Indo-Pacific. With a presence in 25 countries, BGA staff provide bespoke services to clients in 28 markets across the region. We are a fast-growing company and...

  • Regulatory Affairs Specialist

    6 months ago

    Kuala Lumpur, Malaysia BD Full time

    We are **the makers of possible** BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the...

  • Regulatory Affairs Manager

    5 months ago

    Kuala Lumpur, Malaysia Valiram Full time

    **About Valiram** **Valiram Brands**: - Beauty (Victoria’s Secret, Bath & Body Works, Rituals, Molton Brown). - Fashion (Michael Kors, Steve Madden, Tory Burch, Chloe, MLB Korea, Giuseppe Zanotti, Charles & Keith, Pedro etc). - Accessories (Swarovski, Mont Blanc) Travel Retail (Hermes, Bvlgari, The Flying Emporium, Coach, Polo Ralph Lauren, Lacoste,...

  • Regulatory Affairs Specialist

    6 months ago

    Kuala Lumpur, Malaysia BD Full time

    **Job Description Summary**: We are **the makers of possible** BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech...

  • Regulatory Affairs Specialist

    5 months ago

    Kuala Lumpur, Malaysia BD Full time

    **Job Description Summary**: We are **the makers of possible** BD is one of the largest global medical technology companies in the world. _Advancing the world of health_ is our Purpose, and it’s no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech...

  • Assistant Manager

    6 months ago

    Kuala Lumpur, Malaysia VALIRAM Full time

    Develop and clearly communicate regulatory strategies that identify regulatory requirements for product/brand launch to internal and external stakeholders complying to Malaysia Food Regulations. - Ensure that products are registered/compliance in time for importation and/or sale in the stores. Product categories inclusive of but not limited to F&B, non-food...

  • Government Affairs and Tender Manager

    7 months ago

    Kuala Lumpur, Malaysia Novasyte Full time

    Essential Functions: Government Affairs - Develop and maintain relationships with government officials, regulatory bodies, and relevant stakeholders. - Monitor and analyze government policies, regulations, and legislative developments affecting the company. - Advise internal teams on government affairs strategies to ensure compliance and mitigate...