Duopharma Biotech Bhd Group of Companies. is looking for new potential candidates to fill in for EXECUTIVE REGULATORY AFFAIRS (BASED IN GLENMARIE) position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
- To assist in ensuring company’s compliance with all the provisions of the applicable Acts, rules, regulations, codes, standards and guidelines and other legislation and standard applicable to the services
- To assist in ensuring timely registration submission of new pharmaceutical products/ medical devices (i.e.: product preparation and compilation, correspondence and variation) to site Regulatory Affairs and authority
- Responsible to coordinate all the dossier preparation, compilation, review and management as according to Malaysia and oversea requirements.
- Responsible in maintaining registration master list, documentation and recording both in hardcopy and softcopy.
- To familiarize and formalize all registration requirements both for local and export countries. To keep the department and management up to date as per latest requirements and guidelines.
- To prepare and coordinate full compilation of pharmaceutical product dossier with regards to biologics/pharmaceutical/traditional medicine/ health supplement/medical device product registration for both local and export market and to follow through with subsequent correspondence till registration approval.
- To assist in any product query or correspondence by authority and to ensure the corresponding reply within the given timeline.
- To communicate with Analytical department, Formulation department and Regulatory Affairs department from both sites during dossiers preparation and compilation.
- Responsible to ensure all documentation and information related to registration are properly filling and recorded both in hard and soft copy
- Responsible to prepare the information in Package insert for all required product as per Malaysia registration requirement.
- Responsible to ensure registration master list is updated.
- To assist monitoring Regulatory Affairs Senior Supervisor in her task completion.
- To carry out other tasks that assigned by superior or management when needed
- Candidate must possess at least a Bachelor degree in Biomedical Science (Hons) or equivalent.
- At least 5 year(s) of working experience in the related field is required for this position.
- Preferably Junior Executives specializing in Healthcare - Doctor/Diagnosis or equivalent.
- Strong organization skills and documentation skills, strong strategic and effective time management skills
- Strong ability to acquire and comprehend latest regulatory information/guideline/standards, both locally and internationally.
- Strong ability to devise effective regulatory strategies to meet regulatory needs, both locally and internationally.
- Strong ability to work closely with relevant departments (Quality Assurance, Quality Control, Technical Support, Finance and etc.) to meet regulatory objective.
- Full-Time position(s) available.
- Manufacturing Unit - Duopharma (M) Sdn Bhd, Duopharma Manufacturing (M) Sdn Bhd
- Sales and Marketing Unit - Duopharma Marketing Sdn Bhd
- R & D Unit - Duopharma Innovation Sdn Bhd
- Pharmaceuticals and healthcare products and services
How To Apply
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