Regulatory Affairs Associate

1 week ago

West Ryde, Australia Healthcare Professionals Group Full time

**Benefits**
- Excellent mentors as you will learn from experienced regulatory affairs professionals
- Gain exposure to all regulatory affairs activities for a range therapy areas.
- Develop your PV skills while supporting in this area too
- Innovator pharmaceutical company with a respected brand in the market
- Flexible hybrid working arrangement.
- Positive and friendly team and company-wide culture

**About the company**
A reputable and well-established, global pharmaceutical company. Broad range of products and a strong pipeline of innovative products.

**About the opportunity**
This is a combined RA:PV role with a focus on RA (regulatory affairs). The ideal person for this role will have some exposure to both regulatory affairs and PV. You will provide operational support to the Regulatory Affairs team and the Pharmacovigilance team.

**Duties**
- Ensure product compliance with local regulatory requirements and quality systems
- Ensure compliance of product information documents with regulations
- License maintenance activities; label changes, CMC changes, license renewals
- Tracking regulatory procedures and archiving correspondence
- Assist Pharmacovigilance (PV) team in reporting Adverse Events and submit safety reports to relevant bodies
- Provide operational support with Regulatory Affairs and Pharmacovigilance processes

**Skills and Experience**
- Degree qualified in relevant scientific discipline; pharmacy, pharmacology, chemistry are preferred
- Must have 1-2 years’ experience in Regulatory Affairs role working with prescription medicines
- Experience with PV activities would be ideal
- Experience with local TGA or Medsafe regulatory bodies is preferred.
- Must have clear and effective communication
- Personable, team player with strong work ethic

**How to Apply**

**Please note you

**Job details**:

- Location
- West Ryde
- Salary
- Competitive rates
- Job Type
- Contract
- Ref
- BH-39293
- Contact
- Joanna Murphy
- Contact phone
- +61 2 8877 8718
- Posted
- about 3 hours ago

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