Job Description

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\xe2\x80\x99ll 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.

Job Summary

Product Regulatory Affairs (Life Sciences & Agriculture) work includes:

Directing submission development of product registration, progress reports, supplements, amendments, and/or periodic experience reports

Providing strategic product direction to teams on interaction and negotiating evidence with regulatory agencies

Interacting and negotiating with regulatory agency personnel in order to expedite approval of pending registration and answer any questions

Serving as a regulatory liaison on the project team throughout the product lifecycle

Participating in one or all of the following activities: development of product plan, regulatory strategy, risk management, implementation plan, chemistry manufacturing control (CMC)

Ensuring pre-clinical and clinical trial designs meet regulatory requirements

Ensuring rapid and timely approval of new drugs, biologics/biotechnology and/or medical devices and continued approved status of marketed drugs or medical devices

Serving as regulatory representative to marketing or research project teams and government regulatory agencies

Providing advice to development and/or marketing teams on manufacturing changes, line extensions, technical labeling, appropriate regulations and interpretations

Coordinating, reviewing and potentially preparing reports for submission In some organizations, may coordinate and maintain reporting schedules for new drugs, medical devices, and biologic/biotechnology and marketed products notices.



Responsible for the regulatory strategies to optimize the commercial success of marketed products and be responsible for ensuring close collaboration both within GRA and between GRA and other functions and maintain close collaboration with key GRA stakeholders to ensure stakeholder input is integrated into the overall global strategies.

Timeliness and quality of global regulatory functions plans and deliverables: submissions, Health Agency interactions, ensuring compliance with internal and external regulations and procedures, are key performance indicators for this role.

Drive new product regulatory strategy and submission/approval dates for Asia Pacific, China, and Japan (APAJC) market.

Identify, prioritize, and coordinate process improvement initiatives to improve the speed and cost effectiveness of the APAJC QRA organization, while maintaining quality levels required for medical device development and support.

Support strategy development and execution of functional excellence to improve performance of the function and ultimately bring increased value to the business as a strong business partner.

Support the development, implementation, and maintenance of QRA metrics to help drive performance.

Drive regional regulatory intelligence activities, including providing advice and guidance to the organization on the quality & regulatory environment and interpretation of guidance/policy.

Working with subject matter experts to develop clear and concise unified company positions on quality and regulatory proposals to internal and external stakeholders.

Work proactively with all functions for the compliance and quality management.

Lead QRA Excellence projects and APAJC region-wide projects to drive continuous improvement to QRA function.

Regional support for QRA issue escalations, supporting effective communication and presentation.

Participate in advocacy efforts to influence regulatory policies and ensure the organization\'s interests are represented.

Other duties as and when assigned.

Education:

Degree in Engineering or Science or related scientific discipline, or equivalent.

Key Competencies/Behaviours

Able to work independently, be a good team player, and work well under pressure.

Possess good interpersonal skills.

Customer / Quality Focus

Empowerment / Accountability

Mutual Respect / Trust / Loyalty

Experience:

Significant (7-10years) experience in management of quality and regulatory processes

At least 4 years of experience in a APAC regional role capacity.

Alcon