This job has expired

Regulatory Affairs Associate - OTC

Employer
i-Pharm Consulting
Location
New South Wales, Australia
Salary
Negotiable
Start date
7 Dec 2022
Closing date
21 Dec 2022

View more

Discipline
Regulatory Affairs
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
You need to sign in or create an account to save a job.

Job Details

LOCATION

Sydney, Australia

BENEFITS

Competitive Salary Package

ROLE/DESCRIPTION

Assist in the maintenance of product and technical files

Assist in the Preparation of Export registration packages.

Keep up to date with regulation changes in the likes.

Assist in the preparation, submission and maintenance of applications for new product registrations through the TGA.

Review of labelling for compliance

Review, assess and advise Suppliers of Quality requirements for new products and or changes to existing product

Prepare, review and approve finished product and stability specifications as required.

Assist with the management of local and international contract manufacturers to ensure compliance with registered product details and GMP

Review manufacturing and quality documentation and procedures eg BMRs, CAPA, OOS, Change Control, SOP, Validation, Product Specifications, Stability protocols etc

Assist in the development and implementation of labelling and packaging

REQUIREMENTS

  • Life sciences degree (pharmacy preferred)
  • Extensive experience in Australian Regulatory Affairs
  • Regulatory function in another company
  • CAPAs and QMS experience
  • Ability to multitask across different RA disciplines efficiently

ABOUT i-PHARM CONSULTING

i-Pharm Consulting is a specialist Recruitment Company servicing the global Pharmaceutical industry. We provide both permanent and contract staff to a wide range of Pharmaceutical, Medical Device, Biotechnology and Contract Research Organisations (CROs). i-Pharm has specific expertise in Clinical Research, Medical Affairs, Regulatory Affairs, Pharmacovigilance, Quality Assurance and Bioinformatics.

www.i-pharmconsulting.com

TO APPLY


If you would like to discuss this vacancy further, please call Business Manager, Tom Desborough on +61 (0) 2 8310 5843, or email tdesborough@i-pharmconsulting.com. If this role is not suitable, Tom is also available to discuss other possible positions or answer any general questions regarding your career and the current market.


KEY WORDS

Regulatory Associate, Regulatory Affairs Manager, Regulatory Consultant, Senior Regulatory Affairs Consultant, Senior RA Associate, Senior Regulatory Affairs Associate, Regulatory Affairs Associate, Regulatory Affairs Manager, MAA, CTA, Labelling, Regulatory Operations, Submissions/Documentation, Regulatory Training, Regulatory Trainer, Renewals.

Company

i-Pharm Consulting provides Talent Solutions for the global Life Sciences sector.

We are an award-winning international life sciences recruitment company with offices in London, Munich, Frankfurt, Sydney, New York, Charlotte, and Los Angeles. In a highly competitive marketplace, we connect top talent with the very best opportunities.

Since 2008, i-Pharm’s independent, expert, and ethical approach to procuring talent has helped power the pioneering progress made by Pharmaceutical, Biotech and MedTech companies around the world. 

With offices across 3 continents, we have teams servicing the major global life science hubs. We combine local knowledge, with a global network of contacts that allows us to bring together talent and opportunity when it matters most.

For candidates, we become “career partners”. We know them as people, not CVs, learning about their aims, motivations and personal situation. We build open dialogue, provide honest advice and offer ongoing support, whether or not we’re currently working with them. ​

As a result, we have supported many specialists in this focused field throughout their careers, helping them plan their path through life sciences by identifying the right roles for them, not just any roles to suit us.

We change the lives and trajectory of our candidates' careers by offering incredible opportunities with the best clients in the sector.

 

Find Us
Website
Telephone
+44 (0) 20 3189 2299
Location
52 Bedford Row
London
England
WC1R 4LR
GB
You need to sign in or create an account to save a job.

Get job alerts

Create a job alert and receive personalised job recommendations straight to your inbox.

Create alert