Description Regulatory Affairs Pharmacovigilance Lead – Australia
About Astellas: At Astellas, we are making treatments that matter to people. We focus on the patient at the heart of our work, supporting innovative health solutions through a deep understanding of patient experiences. Our patient-centric approach guides all our actions, fostering a culture that values patient awareness across all roles and divisions.
We have developed groundbreaking medicines in immunology, oncology, and urology, extending and saving lives and improving quality of life for patients with overlooked needs. Our focus is on translating early science into treatments that directly benefit patients, from lab to clinic to patient.
Hybrid Working: We support work-life balance with remote working options, allowing you to work where you are most productive.
The Opportunity: This role is within our Regulatory Affairs business unit, reporting to the Regional APAC Lead. You will lead a team of three, contribute to strategic planning, ensure timely applications and approvals, and support brand teams with information and compliance.
Key Responsibilities:
1. Manage the RAPV budget efficiently.
2. Identify and implement strategies to enhance compliance, growth, and profitability.
3. Contribute to the development of global, regional, and local RAPV strategies and plans.
4. Lead a team across Regulatory Affairs and Pharmacovigilance.
Essential Knowledge & Experience:
* Knowledge of regulatory submissions and processes in a pharmaceutical environment.
* Experience liaising with the TGA.
* Strong understanding of ICH / GCP guidelines and regulatory requirements.
* Previous leadership experience.
Preferred Experience:
* Ability to work autonomously and as part of a team.
Education:
* Bachelor’s degree in science, Business, or equivalent preferred.
Additional Information:
* Full-time, permanent position based in Australia.
* Hybrid working model with a minimum of 2 days/week in our Sydney office; flexibility may be required.
* Applicants must be within a commutable distance of the office.
We are an equal opportunity employer, and all qualified applicants will receive consideration without regard to race, color, religion, sex, national origin, disability, veteran status, or any other protected characteristic.
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