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.
Primary Purpose Of Role
Responsible for managing new product registration and license maintenance activities according to regulatory authority requirements and company plan. Partner with local business franchises (Surgical and Vision Care) and functional counterparts (local, regional, and global) to ensure regulatory activities, including, but not limited to submission, labelling, advertising and promotion and regulatory advocacy meet Alcon’s business objectives. Engages in trust-based scientific discussion with regulatory officials, while efficiently gaining regulatory go-ahead for top priority products and programs.
Major Accountabilities:
Duties are listed in order of greatest importance. Other responsibilities may be assigned.
* Responsible for registration activities for all products in both Australia and New Zealand, including associated tasks such as PLR and PAF.
* Key contact to manage the maintenance of existing product registrations to avoid any interruptions to supply, including assessment of RIARs and product shortage notification to relevant authorities.
* Ensure all documents submitted to regulatory agencies are complete, well organised, in regulatory compliance, and presented in a manner that facilitates agency review.
* Responsible for maintaining records of regulatory submissions and communications with relevant regulatory agencies.
* Monitor and, where possible, influence external regulations and standards, including reporting through the regional Regulatory Intelligence process.
* Represent Alcon in industry association forums and, where relevant, influence regulatory policy.
* Maintain close working relationships with internal (e.g. Global and Regional regulatory teams) and external (e.g. local regulatory authorities) stakeholders to ensure registration timelines are met.
* Oversight of GMP clearance compliance and CPDS maintenance.
* Management of key regulatory activities for medical devices and medicines including preparation of submissions to regulatory authorities, both for Australia & New Zealand, management of annual reporting requirements for products and periodic reporting for products supplied under the TGA Special Access Scheme.
* Responsible for promotional material review and ensuring advertising materials meet all regulatory requirements.
* Manage clinical trial activities related to regulatory affairs.
* Provide PL, PBS and Pharmac support as required.
* Completion of monthly RA report to regional team.
* Provision of proposed regulatory submission budget for all products to the Senior Manager of Regulatory Affairs & Quality.
* Provide regulatory support for company compliance initiatives, including SOP development.
* Provide responses to regulatory agencies regarding product information or other topics.
* Maintaining knowledge of pertinent regulations and guidance and escalation, if applicable.
* Oversight of licenses and permit requests, as required.
* Support Quality Assurance tasks or improvement projects across the local QRA function as required.
* Other responsibilities as per management direction.
Education/Qualifications (minimum/essential):
Bachelor’s degree in science, Pharmacy or related discipline.
Skills/Experience:
* 3-5 years’ experience working in a similar role for a medical device or pharmaceutical company.
* Strong knowledge of Regulatory requirements in ANZ.
* Excellent written and verbal communication skills.
* Strong knowledge of MS Office packages (e.g. Excel, Outlook, Word, Powerpoint).
* Proven ability to communicate highly technical information to non-QRA audience both verbally and in writing.
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.
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