Duopharma Biotech Bhd Group of Companies. is looking for new potential candidates to fill in for MANAGER REGULATORY AFFAIRS (BASED IN KLANG) position. If you currently looking for new healthcare job opportunities and qualified with the job desc, feel free to apply this job.
- Responsible to ensure the Duopharma (M) Sdn Bhd and Duopharma HAPI Sdn Bhd compliance with all the provisions of the applicable Acts, rules, regulations, codes, standards and guidelines and other legislation and standards applicable to the pharmaceutical industry.
- Engaging internal and external stakeholders in providing support in terms of regulatory strategy within regulatory perspective, inclusive of providing consultative support
- Management of employee engagement, performance and development within regulatory affairs teams in Klang
- Responsible for Duopharma (M) Sdn Bhd and Duopharma HAPI Sdn bhd drug registration for new pharmaceutical products/ medical devices as well as re-registration for existing products in Malaysia. These also include pharmaceutical products/ medical devices intended to be brought in from overseas for registration and sale in Malaysia
- Responsible to attend and / or to participate in any post-registration activities for product Duopharma
(M) Sdn Bhd and Duopharma HAPI Sdn Bhd ; such as handling complaint, customer queries, recall, adverse drug reaction investigation and other pharmacovigilance activities (where applicable).
- Responsible to attend to all the relevant Regulatory Authorities and to maintain close liaison with government officers namely State and Federal Pharmacy Enforcement officers, National Pharmaceutical Control Bureau, Medical Device Authority for all matters pertaining to regulatory
- Responsible to ensure smooth regulatory activities and to provide regulatory support as and when needed for Duopharma (M) Sdn Bhd and Duopharma HAPI Sdn Bhd
- To coordinate successful the review and compilation of complete pharmaceuticals products/medical devices dossier of all products (In House developed, trading and external developed), in timely manner for regulatory submission to local registration authority, and follow through the pharmaceutical products/medical devices correspondences till registration approval assign in Duopharma (M) Sdn Bhd,KIang and Duopharma HAPI Sdn Bhd.
- To maintain current knowledge of relevant regulations, especially in pre-registration and post registration process for communicate the information to multiple departments and ensure that information is interpreted correctly.
- To manage for the arrangement of the compilation of complete product dossier of all products registration and variation activities in timely manner, for submission to the local registration authority, National Pharmaceutical Regulatory Agency (NPRA) and follow up through the product correspondence till approvals.
- To participate and provide regulatory input to strategic decision making in all project involvement
- To manage and oversee all relevant maintenance activities; licensing renewal, post registration maintenance, product renewal, master-list circulation, and communication approval to the relevant departments.
- To develop and maintain standard operating procedure or local working practices in regulatory departments for Duopharma (M) Sdn Bhd and Duopharma HAPI Sdn Bhd.
- To maintain close liaison with NPRA officer, MDA officer and other regulatory agencies for all matters pertaining to registration and regulatory.
- To establish procedures or systems for publishing documents submission in electronic formats to other relevant departments reference.
- Candidate must possess at least a Bachelor's Degree, Professional Degree in Pharmacy/Pharmacology or equivalent.
- At least 10 year(s) of working experience in the Pharmaceutical Industry from a regulatory affairs perspective
- ACTD & ACTR regulatory knowledge
- ICH, EMA, USFDA, WHO regulatory knowledge
- Knowledge in PIC's GMP and GDP requirements.
- Knowledge in IS0 13485, 9001
- Knowledge in pharmacovigilance activities and audit
- Registered Pharmacy with Pharmacy Board.
- Ability to strategize and execute in a timely manner without compromising on quality of deliverable
- Having the maturity, wisdom and ability to exercise fair judgement in decision making.
- 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
If you confident and feel that this job is suitable to you, go ahead take your action now.
Hope you find your dream hospital job in Selangor.