Deliver a compliant Thailand Healthcare business.
Collaborate with Thailand leadership team on broad business & organization matters.
Lead local registration strategy and planning for base business & new product development to support business objectives and deliver timely approvals.
Build and maintain robust network with regulatory authorities. Engage them in timely manner to ensure smooth approvals.
To ensure a robust submission dossier meeting the most current requirements is prepared in a timely manner.
Manage internal & external approval process of new pack materials, POSM and advertisement materials.
Ensure all relevant regulatory systems and databases are maintained up to date.
Actively participate in cross functional meetings or coordination meetings for projects regionally and globally.
To stay updated with the upcoming changes in regulatory legislation and guidelines and define impact to business.
Negotiate and take a lead in driving long term external advocacy in partnership with Government Relations and relevant industry associations.
Job Qualifications.
Graduate with degree (Bachelors/Masters) in Pharmacy. Registered pharmacist is required.
Having minimum 8 years experience in regulatory associated with Consumer Health products. Extended experience and knowledge with focus on OTC medicines and health supplements will be advantageous.
Demonstrated experience dealing with and influencing related government agencies, i.e.: Thai FDA towards successful regulatory outcomes.
Knowledge and experience in GMP, GDP regulations will be an advantage.
Communication Skills - Able to clearly present information to non-technical leadership teams through the spoken word. Able to write and speak clearly and effectively in English to the team.
Decision Making & Problem Solving - Able to take action in solving problems while exhibiting judgement and a realistic understanding of issues, able to use reason, even when dealing with emotional topics.
Policy and Procedures - Able to relate to routine operations in a manner that is consistent with established policies and procedures.
Analytical Skills - Able to use a systematic approach in solving problems through analysis of problem and evaluation of alternate solutions.
Proficient in English- both written and oral.
Proficient in Computer systems.
Job Schedule.
Full time
Job Number.
R000118013
Job Segmentation.
Experienced Professionals (Job Segmentation)
Job skills required: English, GMP, Product Development