EOI: Regulatory Affairs Associate Job

Date: May 23, 2019

Location: Sydney, NS, AU

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Requisition ID: REG004303

Company Introduction

MSD is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. The difference between potential and achievement lies in the spark that fuels innovation and inventiveness; this is the space where MSD has codified its 125-year legacy. MSD’s success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare. 

MSD’s Regulatory Affairs division helps bring new medical advancements to the world by facilitating the communications and procedures that allow swift, organized compliance across regulatory agencies. As a team of energetic, results-driven individuals, we’re a global network on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices, and solutions to the world on time, every time. 

Role Summary

MSD is seeking expressions of interests from experienced as a Regulatory Affairs Associate based in Macquarie Park, NSW.

You will be responsible in:
  • Applying knowledge of internal/external regulated business challenges to execute and improve processes
  • Independently assessing needs of the business and identifies opportunities to fill gaps
  • Contributing to department and cross-functional team initiatives; lead specific department project initiatives
  • Collaborating with colleagues within related functions
  • Solving complex problems; takes a new perspective to using existing solutions
  • Mentoring colleagues with less experience within own discipline
  • Possessing strong products (including competitors), therapeutic, regulatory knowledge and project management skills

Key Responsibilities:
  • Review, compile and submit Registration Dossiers, and other data packages, within timeframes agreed with manager and in accordance with government, industry and corporate requirements to maintain regulatory compliance and facilitate product supply. 
  • Manage and support the technical and scientific requirements of regulatory applications during the pre-submission, submission, and evaluation process, ensuring timely and high-quality justifications or consultations with the Health Authorities or responses to questions from the Health Authorities in line with global guidance.
  • Ensure cost effective project management, compliance to global and local policies, and effective and timely communication of new or amended registered details to stakeholders within the company.

Qualifications

About You:
  • Must have a pharmacy degree or life sciences degree
  • Have strong experience working within a regulatory environment with sound knowledge of relevant ANZ Regulatory Systems 
  • Demonstrate advanced written communication skills in report writing and document review 
  • Be a strong self-starter with well-developed skills in negotiating, influencing and project management
  • Hold the ability to analyse data and use a logical and analytical approach to problem solving
  • Demonstrate the ability to coach, mentor and inspire a small team of Regulatory affairs Specialists 
  • Enjoy working in an agile environment with the ability to work under pressure to meet deadlines

How to Apply? 

Interested candidates can submit their application online through MSD Career site. If you need further information, you can email April Lim at april.lim@merck.com

What we offer at MSD? 

Your role at MSD is integral to helping the world meet new breakthroughs that affect generations to come, and we’re counting on your skills and inventiveness to help make meaningful contributions to global medical advancement. At MSD, we’re inventing for life.

Search Firm Representatives, Please Read Carefully:  

MSD is not accepting unsolicited assistance from search firms for this employment opportunity.  Please, no phone calls or emails.  All resumes submitted by search firms to any employee at MSD via email, the Internet or in any form and/or method without a valid written search agreement in place for this position will be deemed the sole property of MSD.  No fee will be paid in the event the candidate is hired by MSD as a result of the referral or through other means.


Job: Regulatory Affairs Generic
Other Locations:
Employee Status: Regular
Travel:
Number of Openings:
Shift (if applicable):
Hazardous Materials:
Company Trade Name: MSD


Job Segment: Regulatory Affairs, Medical, Law, Pharmacy, Compliance, Legal, Healthcare

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