Senior Regulatory Affairs Associate

Description

Note: 12 months Contract (Maternity Cover)

Accountability:

Assists the Franchise Regulatory Affairs Manager or delegate with the regulatory maintenance of a portfolio of products.

This includes due diligence and preparation of regulatory submissions to the Australian and New Zealand authorities and government departments for registration of new products, ingredients, changes to marketed products, and consultations when required.

The SRAA is responsible for leading specific projects.

At times will work in collaboration with junior regulatory staff, overseeing their work on the project and providing coaching to them.

Key Responsibilities:


* Ensure timely and efficient registration for new products and product compliance for existing registrations.

Prepare applications for registration of new products and variations to marketed products and rescheduling application, as required and maintain regulatory documentation and databases in line with JJP Procedures


* Critically analyse and provide regulatory strategy for data packages and ingredients for regulatory compliance or new products and identify discrepancies in data presented and request additional data


* Assist in the development of labelling, and develop product information, consumer medicine information in accordance with relevant regulations and codes.


* Suggest and implement improvements to processes and procedures to make the department more efficient.


* Build and maintain strong business partner relationships and attend Project Team meetings as required to ensure timely and accurate communication on projects.

Provide cross functional support for other business areas as required.


* Develop and maintain strong relationships with government officials (TGA and Medsafe), and industry associations through attendance at meetings, conferences and seminars, as appropriate, to ensure compliance with the regulations, information sharing and influence is optimized in relation to individual product portfolios


* Identify, review and disseminate information to relevant company personnel to ensure awareness and compliance with new regulations/codes and their subsequent amendments through the Regulatory Radar process.


* Maintain adequate product knowledge to ensure prompt and professional responses to queries relating to company products.

Review and provide Regulatory Affairs approval of advertising and promotional materials ensuring accuracy and compliance with codes of conduct.

Include Medical Affairs when appropriate when developing new claims.


* Work with Manger by means of performance review system to define own strengths, weaknesses and aspirations and to plan activities that will benefit own development and company's objectives.

Assist in training and development of junior staff in the department, when required

Qualifications/ Experience


* Degree in Pharmacy, life science or similar discipline


* 3 years related experience with ...