Regulatory Affairs Senior Associate

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:

The Regulatory Affairs Senior Associate is responsible for the registration of new drug products & medical devices, and the maintenance of registration of approved drug & medical device products in order to ensure viability of these products in the marketplace.

KEY RESPONSIBILITIES:

1. Ensure submission for product registrations are carried out in a timely manner in compliance with internal and external regulatory requirements for both drugs and medical devices.
2. Prepare, submit, and support product registration applications (according to the Regulatory Plan) leading to timely approvals.
3. Maintain and renew all product licenses / Import/Wholesale License / Establishment License in timely manner to ensure business continuity.
4. Act as back up Company Pharmacist Poison License Holder for the company.
5. Liaise with local regulatory authorities and regional regulatory affairs to deliver timely and commercially advantageous licence approvals.
6. Build effective working relationship with the regulatory agency and follow-up closely on approvals of product registration and amendments.
7. Initiate and coordinate licence renewal & amendment, product lifecycle submissions and approvals and post-market regulatory activities.
8. Manage labelling text and packaging components to ensure compliance with local registered details and corporate prescribing information, as well as maximising the commercial value of the label.
9. Obtain all relevant regulatory Licences in compliance with regulatory requirements.
10. Ensure maintenance of all registration files for reference.
11. Ensure compliance with local, regional and corporate regulatory SOPs and other processes.
12. Provide support in crisis management and product recall.
13. Monitor and report on regulatory projects and regulatory environment on a monthly basis.
14. Supports marketing in providing regulatory information and updates.
15. Manage stock out situations with logistics and obtain special permits to ensure regulatory compliance if necessary.
16. Inform Logistics and respective Business Units regarding registration approvals and re-registration.
17. Develop, retain and improve technical knowledge and skills of local RA associates.
18. Continuously acquire updated technical knowledge through training.
19. Other duties as and when assigned.

WHAT YOU'LL BRING TO ALCON:

Education:

• Tertiary qualified – Pharmacy and possess Pharmacist Poison License with or without postgraduate qualifications.
• Specific qualifications in a regulatory discipline.

Languages:

• Fluent in English and Malay 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.

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