At Alcon, we are driven by the meaningful work we do to help people see brilliantly. We innovate boldly, champion progress, and act with speed as the global leader in eye care. Here, you’ll be recognized for your commitment and contributions and see your career like never before. Together, we go above and beyond to make an impact in the lives of our patients and customers. We foster an inclusive culture and are looking for diverse, talented people to join Alcon
POSITION OVERVIEW:
Responsible for registration of Alcon products both pharmaceutical products and medical device categories or others as related to Thai FDA and other government agency law and regulation.
Ensure the submissions comply with applicable requirements.
Develops and implements strategies and tactics to expedite registrations to contribute earliest possible products launch and attainment of corporate objectives.
Also responsible for all product labeling development, promotional material approval and other regulatory affairs tasks including the post-marketing requirement.
KEY RESPONSIBILITIES:
Register new products.
Maintain company’s licenses both import licenses and product licenses
Ensure the variation submission and approval for the business continuity.
Provide regulatory support of marketed products.
Follow-up legislations and implement applicable requirements. Works with the Industry Association for the shaping up new regulations.
Manage the labeling development for both new products and new packaging. Provide the guidance to relevant associates for the promotional material approval. Submit and obtain approval from Thai FDA.
Ensure Alcon business complies with relevant law and regulation e.g. product pharmacovigilance and safety monitoring program
Ensure the company have all mandatory reports.
Communicate with regional and global regulatory counterpart to obtain the right dossiers, prepare and submit registration dossiers according to current updated requirements e.g. ICH, ACTD and CSDT.
Present registration dossiers to relevant government agency, discuss scientific issues or concern and enhance/expedite the progress of approval.
Escalate and follow the updated procedures of Regional or Global to obtain the proper approval of new projects.
Work with cross-functional associates e.g. supply chain and Marketing to ensure the goods clearance at the port of entry.
Manage all systems for database to maintain records of all registration activities, artworks labeling and promotional material approval.
Provide the report of new regulations and the business impact.
Maintain and create the good relationship with Thai FDA authorities.
Prepare the local SOP to align with the company direction.
WHAT YOU'LL BRING TO ALCON:
EDUCATION
Minimum: University degree in Pharmaceutical Sciences or related field
Preferred: University degree in Pharmaceutical Sciences and Master degree in management or sciences
EXPERIENCE
Minimum: 6 years’ experience in Regulatory Affairs
Preferred: 8-year experience or more in device and pharmaceutical Regulatory Affairs with at least 3 years Regulatory Affairs experience with multinational company
KNOWLEDGE / SKILLS
Thorough knowledge of regulatory requirements at least for medical devices and pharmaceutical products.
Good government relations especially Thai FDA for both Drug Regulation Division and Medical Devices Control Division
Managerial skills, good communication skill, Interpersonal skill, learning agility
Bilingual ability both written and spoken
HOW YOU CAN THRIVE AT ALCON:
Opportunity to work with a leading global medical device company
Collaborate with a diverse and talented team in a supportive work environment
Competitive compensation package and comprehensive benefits
Continuous learning and development opportunities
Alcon Careers
See your impact at alcon.com/careers
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