Regulatory and Medical Affairs Project Manager

4 weeks ago

Chatswood, Australia INOVA PHARMACEUTICALS (AUST) Full time

iNova has been certified best place to work multiple years running. We are innovative, motivated, and passionately solution focused to support our customers in leading a healthy lifestyle. Join the team to experience the reasons why people love working for us

The Opportunity

Reporting to the Director of Regulatory and Medical Affairs, this role provides regulatory and medical expertise on key business development activities: innovation projects, submissions with a clinical focus, external engagement activities and promotional material review.

This role will also manage a pool of regulatory and clinical consultants engaged to provide independent advice on key clinical and regulatory projects.

Key accountabilities include:

  • Clinical submission lead for Regulatory Affairs including developing submissions to support key clinical initiatives (e.g. new indications, literature based submissions, switch)
  • Regulatory and Medical Affairs innovation project feasibility reviews from a medical and regulatory perspective
  • Management of an external pool of regulatory and medical consultants and their assigned projects including briefing on key innovation projects
  • Leading response to industry consultations on key issues impacting business
  • Promotional material reviews to support the Medical Affairs Manager as needed
  • Ongoing support on process improvements in collaboration with other Regulatory and Medical Affairs team members

About You

To be successful in this role you will possess 10 years plus pharmaceutical industry experience in a medical or regulatory affairs role along with a Pharmacy, medical or relevant science degree with strong clinical knowledge.

Other key requirements for this role include:

  • Previous experience in leading and managing multiple projects within a high-volume environment.
  • Excellent stakeholder management and relationship building skills
  • A commercially minded approach and strong sense of business acumen with the ability to develop strategy, including risk analysis within a competitive industry landscape
  • The ability to use scientific and technical knowledge to provide medical or regulatory advice to the business
  • Strong understanding of relevant regulatory requirements for Consumer healthcare and Prescription therapeutic goods medicines
  • Demonstrated ability to develop and execute clinical submission content (e.g. switch/literature-based submissions/new indications)

The Company

iNova has a diverse portfolio of iconic brands and dedicated employees who put people's health first across 20 countries including Australia & New Zealand, Asia and Africa. With a renewed vision, and an energetic and passionate focus, we are a little bit different and proud of what we do.

We know our people perform their best when they are happy and healthy at work, so we offer a range of benefits including:

  • Hybrid and flexible working arrangements
  • Health and wellness initiatives
  • A thriving awards and recognition program
  • Additional annual leave
  • Company paid insurances
  • Paid parental leave
  • And a day off for your birthday

How to Apply 
If you wish to be part of a passionate team within our thriving organisation, focused on bringing innovative products to market, please APPLY TODAY We want you to join us in our pursuit of healthy living

Keeping our employees healthy and safe at work is our priority which is why iNova has introduced a Covid-19 Vaccination Policy for all employees.

It is iNova’s policy not to accept speculative resumes from Agencies, unless the role has been released directly to the agency. If we require your assistance on any roles, we will contact you at the time.

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