Regulatory Affairs Manager
Location Kuala LumpurFULL_TIME
Consultant LO JIE
Date posted 29 April 20192019-04-29 2019-06-28 pharmaceuticals Menara 3 Petronas Persiaran KLCC Kuala Lumpur 50088 Robert Walters
You will be responsible for the continuous development of assigned brands in agreement with the international brand management and strategies by defining and achieving specific sales, profit and market share objectives, developing and implementing marketing strategy within an approved spending budget.
- Compile and submit registration dossiers to local authority to obtain regulatory approvals in a timely manner
- Maintain product licenses by ensuring that all renewals, variations, label updates are submitted and approved within the required time frame to ensure supply continuity and regulatory compliance
- Maintain proper record of regulatory submissions and approvals and update databases for RA information /documents
- Review local promotional materials
- Represent Regulatory Affairs in project teams to provide relevant regulatory advice
- Perform and handle Quality Assurance activities which includes but not limited to: product release, product return and product recall
- Manage relabelling for all products to ensure the compliance of GMP and GDP standard, company’s and relevant regulatory requirements
- Ensure all necessary local Quality SOPs are in place, reviewed or updated periodically
- Conduct GMP and SOP training to relevant employees in the Thailand office
- Obtain knowledge of assigned therapy, market environment and products
- To succeed in the Senior Regulatory Affairs / RA Manager, you will need to be knowledgeable in marketing concepts with good strategical thinking.
- Must be a licensed Pharmacist.
- Masters degree in business or commercial will be an advantage
- At least three years’ experience in commercial and/or sales function in pharmaceutical business
- Experience in product management is required
- Strong interpersonal and communication skills
- Highly self-motivated and work effectively under matrix organisation
- Good computers skills
This international pharmaceutical company is a leader in their field. With its great clients and known for its active innovation and patient-oriented, they've won many awards. The culture is demanding but if you are confident and have a can-do attitude the potential rewards are significant. The company is also very focused on developing and training their people to the highest standards.
If you are driven, determined and want to take the next step in your career, this is the role for you. Great career progression opportunities await the right person in this exciting RA Manager.
Agensi Pekerjaan Robert Walters Sdn Bhd
(formerly known as Robert Walters Sdn Bhd)
Business Registration Number : 729828-T
Licence Number : JTKSM 423C