Manager - Regulatory Affairs (Healthcare)

7 days ago

Shah Alam, Malaysia EPS Ventures Sdn Bhd Full time

**Key Responsibilities**:
**1. Regulatory services & Pharmacovigilance & handling of controlled drug**
- Review and approve marketing and promotion materials. Handle registration and maintain database of sales and advertisement permits issued by relevant authority bodies.
- Responsible for the Regulatory Affairs (RA) functions and team members.
- Provide leadership and support to regulatory team in Malaysia.
- Represents RA as a member of the Leadership Team.
- Guides, plans, and directs the RA staff to create and/or maintain compliance to the applicable regulatory requirements, including but not limited to regulatory assessment, product registration, product notification and post market requirements for all products imported and distributed.
- Poison License holder for the Company.
- Products Life Cycle maintenance in accordance to the regulations.
- Act as primary pharmacovigilance responsible person and other post-market regulatory services.
- Ensure billings of regulatory related services are done correctly and timely.

**2. Others**
- Business compliance to local regulations and guideline
- Good distribution services.
- Advertisement and sales and marketing promotion of healthcare products.
- Product samplings by principals and regulatory agencies, as needed.
- Responsible for all related audits (Internal and External)

**3. Training and Business Development**
- Training in relevant regulations such as pharmacovigilance and complaints for sales and marketing team.
- To support Commercial Departments in business development such as product evaluation and pre-launch activities.
- To represent the Company in pharmacy related activities organized by relevant societies or institution such as NPRA, MDA and etc.
- To support clinical product training to sales & marketing teams and targeted healthcare professionals (HCPs).
- To manage medical and/or product enquiries.
- To lead in medical communication and educational initiatives and program support.

**Key Requirements**:

- Minimum of 5-7 years of experience in regulatory affairs within the pharmaceutical.

**Job Types**: Full-time, Permanent

Pay: RM9,000.00 - RM11,000.00 per month

**Benefits**:

- Cell phone reimbursement
- Health insurance

Schedule:

- Monday to Friday

  • Regulatory Affair Executive

    2 days ago

    Shah Alam, Selangor, Malaysia Malaysian Healthcare Sdn Bhd Full time 36,000 per year

    Responsibilities:-To fully assist in product (medical device) registration and regulatory compliance with relevant government bodies for group of companies-To assist in implementation of ISO and GDPMD standard for group of companies-To assist in all administration jobs related to the regulatory affairs and quality assurance matters-Lead product registration,...

  • Senior Executive, Regulatory Affairs

    2 weeks ago

    Shah Alam, Selangor, Malaysia Novugen Full time 90,000 - 120,000 per year

    About usNovugen is a wholly owned subsidiary of SciTech International, a UAE-based group with over 30 years of experience in the healthcare industry. We specialize in venturing into strategic healthcare businesses and developing world-class healthcare facilities across the globe. With operations in multiple countries across continents, our global presence...

  • Regulatory Affair Executive

    2 days ago

    Shah Alam, Selangor, Malaysia Pelangi Progresif Sdn Bhd Full time 24,000 - 36,000 per year

    Responsibilities:-To fully assist in product (medical device) registration and regulatory compliance with relevant government bodies for group of companies-To assist in implementation of ISO and GDPMD standard for group of companies-To assist in all administration jobs related to the regulatory affairs and quality assurance matters-Lead product registration,...

  • Regulatory Affairs Assistant

    2 weeks ago

    Shah Alam, Malaysia Bits Medical Sdn Bhd Full time

    **Responsibilities: -** - Assist in ensuring company compliance with Medical Device Authority (MDA) requirements. - Support in Establishment Licensing and Medical Device Registration matters. - Liaise with overseas manufacturers for regulatory documentation. - Assist in the renewal of certificates and licenses accurately and on time. - Maintain and update...

  • Executive Regulatory Affair

    1 week ago

    Puncak Alam, Malaysia FORESIGHT INDUSTRIES SDN BHD Full time

    **Requirements**: - Bachelor's degree in Quality Management or a related field - Minimum 2 years of experience in regulatory affairs, preferably in the medical device. - Strong attention to detail and ability to work under pressure to meet tight deadlines. - Excellent communication, organizational and project management skills. - Proficiency in regulatory...

  • Regulatory Affairs

    7 days ago

    Shah Alam, Malaysia Kino Biotech (M) Sdn Bhd Full time

    **Job Summary**: The Regulatory Affairs and Quality Control Executive plays a crucial role in supporting the Regulatory Affairs and Quality Control Manager in ensuring compliance with regulatory standards and maintaining high-quality product standards. This position involves active participation in product registration activities, quality control processes,...

  • Regulatory Affairs Specialist

    2 weeks ago

    Shah Alam, Malaysia Yes Health Sdn Bhd Full time

    To prepare compilation of pharmaceutical product dossier submission to NPRA and follow through with subsequent correspondence until approval to formalize changes requiring regulatory submission initiated in the company. - To be the person in charge/coordinator for variation related activities in the department. Responsible to ensure full adherence to...

  • Medical Affairs Intern

    2 days ago

    Shah Alam, Selangor, Malaysia Clinigen Full time 20,000 - 30,000 per year

    Join Clinigen as a Medical Affairs Intern and gain invaluable hands-on experience within the dynamic field of pharmaceutical medical affairs. You will work closely with our experienced team to support our mission of delivering the right medicine to the right patient at the right time. This internship will provide you with exposure to various aspects of...

  • International Patient Affairs Executive

    4 hours ago

    Shah Alam, Selangor, Malaysia MSU MEDICAL CENTRE Full time 36,000 - 54,000 per year

    MSU Medical Centre is seeking a proactive and resilient International Patient Affairs Executive to join our dedicated team. The successful candidate will play a key role in managing and coordinating international patients' experiences — ensuring exceptional service from inquiry to post-treatment care.Key Responsibilities:Manage and coordinate international...

  • Senior Executive, Regulatory Affairs

    6 hours ago

    Shah Alam, Selangor, Malaysia Fraser & Neave Holdings Bhd (F&N) Full time

    Job Purpose1.To provides regulatory, scientific and nutrition support to the business unit.2.The incumbent keeps abreast of local & oversea countries regulatory knowledge.Key Accountabilities1.Ensure raw material, product recipe / formulation, label and communication material compliance to the regulatory requirement of Malaysia, Brunei and other markets as...