Regulatory Affairs Manager – Pharmaceuticals / Medical Devices (The position has been filled)
Australia, Victoria
Full Time
27/12/2017
  • Permanent Full Time Role with ASX listed Company
  • Professional, Friendly and Supportive Work Environment
  • Growing Company with Excellent Facilities and a Good Culture

 

CLIENT

Our client is a pharmaceutical company dedicated to developing and commercialising specialty and generic topical pharmaceuticals. With a strong product pipeline and continued growth, the company is listed on the ASX.

Boasting modern facilities and state of the art laboratories, our client offers a friendly, supportive work environment and access to parking as well as public transport.

 

ROLE

This important role will contribute to the management of regulatory affairs for generic drugs – mainly dermatological products and medical devices. You will ensure that products are delivered in full, and on time, including all requisite activities including risk assessments, development and maintenance of documentation, strategic planning for submissions of generic products, submission and acceptance by various regulatory bodies, especially FDA.

An experienced Regulatory Affairs Manager, the successful candidate will possess at least 5 years previous experience in Regulatory Affairs including dossier writing and preparation of generic drug (ANDA) submissions in the pharmaceutical sector together with experience in dealing with US regulatory authorities.

The ideal candidate will have dermatology and / or device regulatory experience as well as having experience in direct interactions with the FDA. Electronic submissions experience is highly desirable.

As the successful candidate, you will be able to balance the strategic demands of regulatory affairs within the commercial landscape. You will have a high degree of initiative and will be able to operate with a high degree of autonomy.

Interpersonal communication skills will be paramount for this challenging role, including excellent written communication, due to the highly technical nature of the industry and the interaction with various regulatory agencies, commercial partners and suppliers.

 

REQUIREMENTS

To be successful you will have a ‘can do’ attitude, proven track record and ability to be part of a champion team.

A summary of required criteria include:

  • Minimum of a BSc in Biochemistry, Pharmacology or other similar area
  • A minimum of five years’ previous experience in Regulatory Affairs including dossier writing and preparation of generic drug (ANDA) submissions
  • At least five years’ experience in topical pharmaceuticals and/or medical devices
  • Experience in dealing with US regulatory authorities in the pharmaceutical sector
  • Must have experience in direct interactions with the FDA
  • Development and execution of regulatory strategies, including project planning and implementation
  • MUST have a good eye for detail, superior written communication skills, be a good team player and a problem solver
  • Ability to identify, analyse and manage risks associated within areas of responsibility and expertise

 

APPLICATIONS

To discuss this excellent opportunity please call our team on 03 9516 0100. To apply, please click the ‘Apply Now’ button. Please ensure you attach a Resume and Cover Letter in Word Format addressing the full selection criteria.

 

THANK YOU

Thank you for taking the time to apply for these roles. As we receive a large number of applications every day, we can only contact short-listed candidates. If you do not receive a call from our Recruiters, then your details will remain on our database for future suitable roles.