General Information

Job Advert Title
Regulatory Affairs Pharmacovigilance Lead – Australia
Location
Australia
Function/Business Area
Missing req details TBC
Department
Regulatory Affairs Department
Employment Class
Permanent

Description

Regulatory Affairs Pharmacovigilance Lead – Australia

About Astellas:

At Astellas we are making treatments that matter to people.

We are tackling the toughest health challenges putting the patient at the heart of every move we make.

Our global vision for Patient Centricity is to support the development of innovative health solutions through a deep understanding of the patient experience. At Astellas, Patient Centricity isn’t a buzzword - it’s a guiding principle for action. We believe all staff have a role to play in creating a patient-centric culture and integrating an awareness of the patient into our everyday working practices, regardless of our role, team or division.

We have developed ground-breaking, innovative medicines in immunology, oncology and urology. Our medicines are extending and saving the lives of cancer patients, making transplantation possible and improving the quality of life for those living with conditions where needs are often overlooked.

We take a patient-focused approach, that allows us to convert brilliant early science into treatments and solutions that directly improve and save patients’ lives.

From lab to clinic to patient, we focus on the most promising science, empower the best talent to pursue it, and develop life-changing solutions alongside the best partners.

Hybrid Working:

At Astellas we recognise the importance of balancing your work and home life. This role offers a remote working solution so you can optimise the most productive work environment for you to succeed and deliver.

The Opportunity:

This is role sits within our Regulatory affairs business unit and reports to the Regional APAC Lead for Regulatory affairs. Your role is to provide leadership to your 3 direct reports and sits within the leadership team. Your role will be to ensure that applications and approvals are on time, and you will be required to support the brands and provide information to them.

At Astellas you are empowered and supported with hybrid working options where you can work where you feel most comfortable and productive.

Key Responsibilities:

  • Manage the RAPV budget in a cost-efficient manner.
  • Identify and implement ways for RAPV to contribute to compliance, growth and profitability of the affiliate.
  • Contribute to the development and implementation of global, regional and local RAPV long-term, mid-term and annual strategy and plans.
  • Lead a team of associates across Regulatory affairs and Pharmacovigilance.

Essential Knowledge & Experience:

  • You will have knowledge of Regulatory submissions and processes within a pharmaceutical environment.
  • You will be experienced in liaising and working with the TGA.
  • Must demonstrate strong knowledge of ICH/GCP guidelines and regulatory requirements.
  • Have previous experience in leadership.

Preferred Experience:

  • Knowledge of how to work autonomously and as a team.

Education:
  • Preferred bachelor’s degree in science, Business or equivalent.

Additional information:

  • This is a full time, permanent position.
  • This position is based in Australia.
  • This position follows our hybrid working model. Role requires a blend of home and minimum 2 days per week in our Sydney office. Flexibility may be required in line with business needs. Candidates must be located within a commutable distance of the office.

We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, national origin, disability status, protected veteran status, or any other characteristic protected by law.


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