Job Description

Job Header

Senior Regulatory Affairs Associate

Advertiser: Lipa Pharmaceuticals LtdMore jobs from this company

Job Information

Job Listing Date
2 Nov 2018
Location
Sydney, South West & M5 Corridor
Salary
Exciting Opportunity!!!
Work Type
Full Time
Classification
Healthcare & Medical, Pharmaceuticals & Medical Devices

Senior Regulatory Affairs Associate

About Us

Lipa Pharmaceuticals is a thriving, innovative and market leading contract manufacturer of complementary health care products based at Minto (close to Campbelltown) in South West Sydney.  We currently service the bulk of Australia’s leading brands and various overseas customers across North and South America, Europe, Asia and the Pacific region. Due to unprecedented and exceptional growth in both the local and international channels, Lipa Pharmaceuticals is looking to strengthen its Regulatory expertise, especially for the global markets, and is seeking to appoint a Senior Regulatory Affairs Associate (SRA).    

About the Role

The SRA Associate will be based in our New Product Development department and requires a positive and enthusiastic individual wishing to progress their career to a senior level in Regulatory Affairs.  Your responsibilities will include:

  • Product specification and raw material documentation preparation and maintenance.
  • Preparation of various documents including, change controls, GMP agreements.  
  • Working closely with QA to develop quality assurance related documentation.
  • Dossier preparation and product registration processes for overseas markets.
  • Listing, registering and or submitting product variation applications for products with the TGA and select overseas regulatory bodies on behalf of various clients.
  • Supporting the business through input, development and implementation of regulatory strategies.
  • Staying abreast of local and overseas regulatory changes and requirements as well as updating relevant team members of changes.
  • Maintaining an appropriate level of regulatory knowledge in regard to analysis of claims, product indications, label designs and final product release criteria.

About You

You will be a dynamic and self-motivated person ideally with previous exposure and understanding of the TGA and the various regulations, codes and processes underpinning the listing and or registration of complementary products.  You will also:

  • Be degree qualified in a relevant scientific field
  • Have a minimum 3-5 years’ experience in a similar role, ideally within the complementary and/or pharmaceutical industry
  • Have excellent interpersonal, negotiation and problem solving skills
  • Have the ability to interact with various diverse functional groups
  • Be able to effectively multitask and prioritise
  • Have a flexible, customer centric, hands-on approach
  • Have excellent verbal communication, analytical and written skills
  • Have a strong attention to detail
  • Be a positive, flexible team player with a with a  “can do” attitude
  • Have good time management and organisational skills

What’s in it for you?

  • A competitive salary package
  • The opportunity to develop and progress within the business
  • A supportive workplace culture where great work is recognised and rewarded

Lipa is a well-recognised and market leading company that offers rewarding careers and the chance to grow as our business grows.

How to Apply

Please submit a covering letter outlining why you want to work for Lipa Pharmaceuticals and a current resume.

Successful candidates will be required to undergo Police, Medical and Reference checks. 

Please note - only candidates deemed suitable by Lipa Pharmaceuticals, will be contacted for interview.

www.lipa.com.au

About Us

Lipa Pharmaceuticals is a thriving, innovative and market leading contract manufacturer of complementary health care products based at Minto (close to Campbelltown) in South West Sydney.  We currently service the bulk of Australia’s leading brands and various overseas customers across North and South America, Europe, Asia and the Pacific region. Due to unprecedented and exceptional growth in both the local and international channels, Lipa Pharmaceuticals is looking to strengthen its Regulatory expertise, especially for the global markets, and is seeking to appoint a Senior Regulatory Affairs Associate (SRA).    

About the Role

The SRA Associate will be based in our New Product Development department and requires a positive and enthusiastic individual wishing to progress their career to a senior level in Regulatory Affairs.  Your responsibilities will include:

  • Product specification and raw material documentation preparation and maintenance.
  • Preparation of various documents including, change controls, GMP agreements.  
  • Working closely with QA to develop quality assurance related documentation.
  • Dossier preparation and product registration processes for overseas markets.
  • Listing, registering and or submitting product variation applications for products with the TGA and select overseas regulatory bodies on behalf of various clients.
  • Supporting the business through input, development and implementation of regulatory strategies.
  • Staying abreast of local and overseas regulatory changes and requirements as well as updating relevant team members of changes.
  • Maintaining an appropriate level of regulatory knowledge in regard to analysis of claims, product indications, label designs and final product release criteria.

About You

You will be a dynamic and self-motivated person ideally with previous exposure and understanding of the TGA and the various regulations, codes and processes underpinning the listing and or registration of complementary products.  You will also:

  • Be degree qualified in a relevant scientific field
  • Have a minimum 3-5 years’ experience in a similar role, ideally within the complementary and/or pharmaceutical industry
  • Have excellent interpersonal, negotiation and problem solving skills
  • Have the ability to interact with various diverse functional groups
  • Be able to effectively multitask and prioritise
  • Have a flexible, customer centric, hands-on approach
  • Have excellent verbal communication, analytical and written skills
  • Have a strong attention to detail
  • Be a positive, flexible team player with a with a  “can do” attitude
  • Have good time management and organisational skills

What’s in it for you?

  • A competitive salary package
  • The opportunity to develop and progress within the business
  • A supportive workplace culture where great work is recognised and rewarded

Lipa is a well-recognised and market leading company that offers rewarding careers and the chance to grow as our business grows.

How to Apply

Please submit a covering letter outlining why you want to work for Lipa Pharmaceuticals and a current resume.

Successful candidates will be required to undergo Police, Medical and Reference checks. 

Please note - only candidates deemed suitable by Lipa Pharmaceuticals, will be contacted for interview.

Report this job advert

Be careful- Don’t provide your bank or credit card details when applying for jobs. If you see something suspicious .

Share this role