REGULATORY AFFAIRS EXECUTIVE (JANSSEN DIVISION)-5965140312
Description
- Manage the preparation and submission of new product registrations and follow-up closely on queries and through approval.
- Manage and coordinate product life cycle management.
- Ensure regulatory compliance with local regulatory requirements.
- Foster and maintain professional relationships with the health authorities.
- Provide regulatory support to local business, including timely registration of new product and line extensions to support new product launches, tender application, and whenever necessary.
- Manage annual quota demand and permits applications for Dangerous Drug and psychotropic products.
- Maintain regulatory work processes and tracking tools that improve performance levels and transparency.
- Promote regulatory intelligence in both local and regional initiatives.
Qualifications
- Graduated with a degree in Pharmacy and registered with the Pharmacy Board of Malaysia.
- 1-2 years of experience in regulatory affairs with a pharmaceutical industry.
- Has demonstrated a solid track record in product registration and has good working relationship with the health authorities.
- Demonstrate proficiency in written and spoken Bahasa Malaysia and English.
- Self-driven, pro-active and fast learner.
- Able to multi-task, react swiftly to urgent issues and work within stipulated deadlines.
- Meticulous with an eye for details.
- Must be a team player with good interpersonal skills.
Primary Location:Asia Pacific-Malaysia-Selangor-Petaling Jaya
Organization: Johnson & Johnson Sdn. Bhd. (8275)
Travel:No
Job Function: Regulatory Affairs
Description
- Manage the preparation and submission of new product registrations and follow-up closely on queries and through approval.
- Manage and coordinate product life cycle management.
- Ensure regulatory compliance with local regulatory requirements.
- Foster and maintain professional relationships with the health authorities.
- Provide regulatory support to local business, including timely registration of new product and line extensions to support new product launches, tender application, and whenever necessary.
- Manage annual quota demand and permits applications for Dangerous Drug and psychotropic products.
- Maintain regulatory work processes and tracking tools that improve performance levels and transparency.
- Promote regulatory intelligence in both local and regional initiatives.
Qualifications
- Graduated with a degree in Pharmacy and registered with the Pharmacy Board of Malaysia.
- 1-2 years of experience in regulatory affairs with a pharmaceutical industry.
- Has demonstrated a solid track record in product registration and has good working relationship with the health authorities.
- Demonstrate proficiency in written and spoken Bahasa Malaysia and English.
- Self-driven, pro-active and fast learner.
- Able to multi-task, react swiftly to urgent issues and work within stipulated deadlines.
- Meticulous with an eye for details.
- Must be a team player with good interpersonal skills.
Primary Location:Asia Pacific-Malaysia-Selangor-Petaling Jaya
Organization: Johnson & Johnson Sdn. Bhd. (8275)
Travel:No
Job Function: Regulatory Affairs