▷ (Apply Now) Regulatory Affairs Associate

4 weeks ago

Sydney, Australia Viatris Inc. Full time

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Regulatory Affairs Associate

Postuler locations Sydney, New South Wales, Australia time type Temps plein posted on Offre publiée hier job requisition id R5661486 Upjohn Australia Pty Ltd.

Chez Viatris, nous envisageons la santé non pas telle qu'elle est mais telle qu'elle devrait être. Nous agissons avec courage et notre positionnement unique est source de stabilité dans un monde où les besoins en matière de santé sont en constante évolution. Viatris permet à chacun dans le monde entier de vivre en meilleure santé à chaque étape de sa vie. Via trois axes majeurs:

Accès: En fournissant des médicaments de haute qualité et reconnus, quels que soient le lieu de résidence ou la situation de chaque patient.

Leadership: En favorisant l’évolution de nos activités de façon durable et le développement de solutions innovantes pour améliorer la santé des patients.

Partenariat: En valorisant notre expertise collective afin de donner accès à tous à nos produits et services.

Every day, we rise to the challenge to make a difference; the Regulatory Affairs Associate role is key to ensure continuity of supply via life cycle maintenance activities for our existing portfolio and to support the registration of new medicines in Australia. Compliance to local and global regulations is essential in the ever-changing regulatory environment.

Key responsibilities for this role include:

- Deliver regulatory submissions within required timeframes;
- Ensure company databases and systems are accurate and current by drafting, updating, reviewing and verifying entries;
- Ensure our company’s change control system is accurate and current by creating, reviewing and/or completing change records as required;
- Maintain compliance with relevant regulations and codes and provide regulatory advice to company personnel as required;
- Maintain compliance and up-to-date training with internal Policies, Standard Operating Procedures, and Work Instructions, and adhere to company values and expectations;
- Complete allocated special projects;
- Collaborate cross-functionally to support submissions and projects where required;
- Support regulatory administrative activities as needed;
- Communicate and endorse safety practices, monitor key safety performance indicators and visibly participate in promoting safety policies and initiatives.

The minimum qualifications and experience for this role are:

- Bachelor’s degree or equivalent in Pharmacy, Science or Chemistry.
- At least two years’ experience in regulatory affairs ideally with prescription medicines.
- Understanding of local and international regulatory guidelines.
- Capacity to investigate and evaluate a problem to develop effective solutions.
- Excellent communication skills (written and verbal).
- Ability to multitask and work to deadlines.
- Demonstrated ability to work well in a team environment and co-operate with others to achieve goals within specified timeframes.
- Must be eligible to work in Australia (Australian Citizen or appropriate Visa holder).

Position Title: Regulatory Affairs Associate

Location: Sydney Head Office, Millers Point, NSW

Employment: Full Time, Fixed Term (9 months)

Chez Viatris, nous proposons des salaires compétitifs, des bénéfices et un environnement inclusif au sein duquel vous pouvez mettre à profit votre expérience, vos perspectives et vos compétences pour aider à avoir un impact positif sur la vie des autres.

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