Skip to main content
Alcon

Senior Associate, Regulatory Affairs Strategy

1w

Alcon

Pasig City, PH · Full-time · PHP 1,200,000 – PHP 2,000,000

About this role

At Alcon, the global leader in eye care, we boldly innovate, champion progress, and act with speed to help people see brilliantly. The Sr. Associate, Regulatory Affairs Strategy manages registration of new products and maintenance of approved product registrations. This role ensures products are distributed in compliance with applicable local regulations to support market viability.

Day-to-day involves preparing and submitting product registration applications according to the Regulatory Plan for timely approvals. Maintain and renew all product registrations and licenses to ensure business continuity. Liaise with local regulatory authorities and build effective relationships for commercially advantageous approvals.

Manage labelling text and packaging components to comply with local registered details and corporate prescribing information. Coordinate license renewals, amendments, product lifecycle submissions, and post-market activities. Support marketing with regulatory information, logistics on stock outs, and crisis management including product recalls.

Monitor and report on regulatory projects and the environment monthly. Act as backup Company Pharmacist while ensuring compliance with local, regional, and corporate SOPs. Join an inclusive culture that recognizes contributions and invites diverse talent to shape eye care's future.

Career opportunities empower growth and fulfillment through continuous training for updated technical knowledge. Together, go above and beyond for lasting impact on patients and customers. Maintain all registration files and inform business units on approvals.

Requirements

  • Bachelor of Science Degree in Pharmacy or Industrial Pharmacy
  • Must possess a professional license in Pharmacy
  • Fluent in English and Tagalog language (oral and written)
  • Knowledge of local regulatory requirements for product registrations
  • Familiarity with product lifecycle management and post-market activities
  • Ability to comply with local, regional, and corporate regulatory SOPs
  • Experience liaising with regulatory authorities in pharmaceutical industry

Responsibilities

  • 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 leading to timely approvals
  • Maintain and renew all product registrations and licenses to ensure business continuity
  • Liaise with local regulatory authorities and regional regulatory affairs to deliver timely licence approvals
  • Build effective working relationship with the regulatory agency and follow-up on approvals
  • Manage labelling text and packaging components to ensure compliance with local registered details
  • Monitor and report on regulatory projects and regulatory environment on a monthly basis
  • Act as back up Company Pharmacist for the company

Benefits

  • Inclusive culture that celebrates contributions
  • Career opportunities that empower growth and fulfillment
  • Opportunity to make lasting impact on patients and customers
  • Work with diverse, talented individuals shaping the future of eye care