At Alcon, we are inspired by the meaningful work we do to help people see brilliantly. As the global leader in eye care, we boldly innovate, champion progress, and act with speed. We recognize and celebrate the contributions of our people, offering career opportunities that empower growth and fulfillment. Together, we go above and beyond to make a lasting impact on the lives of our patients and customers. We cultivate an inclusive culture and invite diverse, talented individuals to join us in shaping the future of eye care.
POSITION OVERVIEW:
The Sr. Associate, Regulatory Affairs Strategy is responsible for the registration of new products, and for the maintenance of approved product registrations. The role ensures that products are distributed in compliance with applicable local regulations to support continued market viability.
KEY RESPONSIBILITIES:
Regulatory Affairs
Ensure submission for product registrations are carried out in a timely manner in compliance with internal and external regulatory requirements.
Prepare, submit, and support product registration applications (according to the Regulatory Plan) leading to timely approvals.
Maintain and renew all product registrations and licenses to operate in a timely manner to ensure business continuity.
Act as back up Company Pharmacist for the company.
Liaise with local regulatory authorities and regional regulatory affairs to deliver timely and commercially advantageous licence approvals.
Build effective working relationship with the regulatory agency and follow-up closely on approvals of product registration and amendments.
Initiate and coordinate license renewal & amendment, product lifecycle submissions and approvals and post-market regulatory activities.
Manage labelling text and packaging components to ensure compliance with local registered details and corporate prescribing information, as well as maximizing the commercial value of the label.
Obtain all relevant regulatory approvals in compliance with regulatory requirements.
Ensure maintenance of all registration files for reference.
Ensure compliance with local, regional and corporate regulatory SOPs and other processes.
Provide support in crisis management and product recall.
Monitor and report on regulatory projects and regulatory environment on a monthly basis.
Supports marketing in providing regulatory information and updates.
Manage stock out situations with logistics and obtain special permits to ensure regulatory compliance if necessary.
Inform Logistics and respective Business Units regarding registration approvals and re-registration.
Continuously acquire updated technical knowledge through training.
Other duties as and when assigned.
Key Performance Indicators
Timely registration of new drug products and medical devices.
Accurate maintenance of new registrations & product lifecycle management
Ideal Background
Education:
Bachelor of Science Degree in Pharmacy or Industrial Pharmacy
Must possess a professional license in Pharmacy
Languages:
Fluent in English and Tagalog language (oral and written)
Key Competencies/Behaviours:
Results Driven
Teamwork & Leadership
Customer / Quality Focus
Empowerment / Accountability
Mutual Respect / Trust / Loyalty
Experience:
2-3 years of experience as an associate in regulatory affairs (pharma and/or medical device) dealing with a wide variety of registration projects and issues.
Good interpersonal and communication skills
Integrity, responsive, high commitment
Independent and team player, demonstrating high level of initiative and flexibility
Computer literate and knowledge of Excel and PDF
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
ATTENTION: Current Alcon Employee/Contingent Worker
If you are currently an active employee/contingent worker at Alcon, please click the appropriate link below to apply on the Internal Career site.