Manager, Regulatory Affairs

vor 1 Woche

Perth, Österreich Pharmalex Vollzeit
We are growing, grow with us

Are you looking for a dynamic company with daily new challenges and opportunities?

Then, Pharmalex is your career opportunity.Pharmalex is one of the leading service companies for the Pharmaceutical Industry globally and is specialized in all aspects of drugs and medical devices approval, of the marketdevelopment and any action of effective product maintenance.

Regulatory Affairs Associate / Senior Associate

We have an opportunity for a Regulatory Affairs Associate or Senior Associate to join our Pharmaceutical Regulatory Consulting team in Australia. Internally the position’s title is Manager, Regulatory Affairs. In this role you will have the opportunity to work with a broad range of clients, predominantly in the pharmaceutical and health care sectors. Your primary objective is to maximise client commercial success by ensuring appropriate licensing, marketing and regulatory compliance of client’s products. In this role, you will advise, support and manage regulatory submissions and approvals for products, including liaising with clients and regulatory teams and third-party subject matter experts. At times you will act as the authorized agent to coordinate and lead pre-submission meetings and other key meetings with Health Authorities

Your Profile

You have formal qualifications in science or similar field and a minimum of 5 years’ experience working in regulatory affairs either for prescription products in industry or a consulting setting.

You will have exposure with Australian and New Zealand regulatory environments with extensive hands-on experience in the preparation of regulatory submissions with a strong track record of success.

You are a natural problem-solver, commercially minded, and exceptional communication skills and stakeholder management. You thrive on diversity and challenge andcan effectively prioritise and manage several projects at once.

You are a team player and enjoy collaborating with your peers to deliver to client’s expectations.

We Offer

By joining the PharmaLex Australia team you will become part of a team renowned as specialists in our field. Sharing knowledge and expertise with others is part of every day.You will work closely with experienced Senior Managers, Associate Directors and Directors who have extensive Consulting experience.

We offer a range of flexible working options including part time, varying start and finish times and remote working from home.

Whilst we are serious about our business we don’t take ourselves too seriously and aim to create a fun team environment where all can thrive.

Our head office is based in St Leonard’s, Sydney, NSW, Australia.

If you are interested in joining our Pharmalex team taking over this challenging job opportunity in our future-oriented company, we are looking forward to receiveyour application documents stating your earliest possible starting date, any visa requirements and salary expectations on-line.

For further information please don’t hesitate to contact us:

Jennie Brandenburg,Senior Manager, Human Resources Australia

Agencies only by prior agreement for the specific job opportunity.

#J-18808-Ljbffr

  • Manager Regulatory Affairs

    vor 2 Monaten

    Perth, Österreich Laborie Medical Technologies Corp Vollzeit

    We believe that great healthcare is an essential safeguard of human dignity.At Laborie, we know the work we do matters – it’s what fuels our motivation and contributes to our success. If you’re ready to make a positive impact in the lives of patients across the globe, we’d like to meet you.We support and empower our employees to grow their careers in...

  • Manager Regulatory Affairs

    vor 2 Wochen

    Perth, Österreich Ferring Holding SA Vollzeit

    Manager Regulatory Affairs page is loadedManager Regulatory AffairsApplylocationsPymble, Australiatime typeFull timeposted onPosted Yesterdayjob requisition idR0029674Job Description:At Ferring Pharmaceuticals, we help people around the world build families and live better lives. We are entrepreneurial and innovative, with a global team focused on scientific...

  • Regulatory Affairs Operations Team Lead

    vor 1 Monat

    Perth, Österreich Australia Pty Vollzeit

    Job DescriptionRegulatory Affairs Operations Team Lead ANZLooking for a role within an Animal Health business renowned for innovation, growth and diversity?Are you seeking the opportunity to develop your career?Join a diverse workforce that values collaborationThe Animal Health sector is a highly regulated and very competitive market. Success is often...

  • Regulatory Affairs Operations Team Lead

    vor 4 Wochen

    Perth, Österreich Australia Pty Vollzeit

    Job DescriptionRegulatory Affairs Operations Team Lead ANZLooking for a role within an Animal Health business renowned for innovation, growth and diversity?Are you seeking the opportunity to develop your career?Join a diverse workforce that values collaborationThe Animal Health sector is a highly regulated and very competitive market. Success is often...

  • Director, Regulatory Affairs Companion Diagnostics

    vor 4 Wochen

    Perth, Österreich Daiichi Sankyo Company, Limited Vollzeit

    Director, Regulatory Affairs Companion Diagnostics page is loadedDirector, Regulatory Affairs Companion DiagnosticsApplyremote typeHybrid Work ArrangementlocationsBasking Ridge, NJtime typeFull timeposted onPosted 30+ Days Agojob requisition idR2897Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply...

  • Director, Regulatory Affairs Companion Diagnostics

    vor 4 Wochen

    Perth, Österreich Daiichi Sankyo Company, Limited Vollzeit

    Director, Regulatory Affairs Companion Diagnostics page is loadedDirector, Regulatory Affairs Companion DiagnosticsApplyremote typeHybrid Work ArrangementlocationsBasking Ridge, NJtime typeFull timeposted onPosted 30+ Days Agojob requisition idR2897Join a Legacy of Innovation 110 Years and Counting!Daiichi Sankyo Group is dedicated to the creation and supply...

  • Executive Manager, Regulatory Affairs Australia Posted on 06/06/2024 Be the First to Apply

    vor 3 Wochen

    Perth, Österreich Westpac Group Vollzeit

    • Permanent role.• Sydney or Melbourne based – hybrid working.• Great opportunity to join Westpac’s Group Regulatory Affairs team.How will I help?You will be responsible for leading engagements with Westpac’s key regulators to help deliver Westpac’s regulatory strategy.Key responsibilities include:•Leading regulatory relationships across a...

  • Manager Regulatory Compliance

    vor 4 Stunden

    Perth, Österreich Qantas Airways Vollzeit

    Manager Regulatory Compliance page is loaded Manager Regulatory Compliance Apply locations Perth time type Full time posted on Posted Yesterday job requisition id R98677 Challenge yourself to lead Network Aviation’s airli ne regulatory compliance function Together we’ll m ake a positive contribution to the...

  • Regulatory Approvals Advisor

    vor 3 Wochen

    Perth, Österreich Inpex Corporation Vollzeit

    Press Tab to Move to Skip to Content Link At INPEX, our energy is helping to shape a brighter future. We are proudly supporting positive outcomes in Australian communities, through jobs, training and social and economic benefits. Our Australian energy portfolio includes Ichthys LNG which we operate, plus participating interests in Prelude FLNG,...

  • State Government Affairs

    vor 1 Monat

    Perth, Österreich Novartis Farmacéutica Vollzeit

    Job IDREQ-10007787May 19, 2024AustraliaSummaryNovartis is a global pharmaceutical and healthcare company committed to improving the lives of patients and making a lasting impact on global health. With a rich history spanning over 250 years, Novartis has established itself as a leader in the industry, combining cutting-edge medical science with innovative...

  • Director, Regulatory Risk Management | Forensic

    vor 1 Monat

    Perth, Österreich FTI Consulting, Inc Vollzeit

    Director, Regulatory Risk Management | Forensic & Litigation ConsultingThe Regulatory Risk Management team at FTI Consulting supports financial institutions, regulators, governments and enforcement agencies across the full spectrum of financial regulation. Our service offerings include regulatory and business change programmes; governance and conduct...

  • Director, Regulatory Risk Management | Forensic

    vor 4 Wochen

    Perth, Österreich FTI Consulting, Inc Vollzeit

    Director, Regulatory Risk Management | Forensic & Litigation ConsultingThe Regulatory Risk Management team at FTI Consulting supports financial institutions, regulators, governments and enforcement agencies across the full spectrum of financial regulation. Our service offerings include regulatory and business change programmes; governance and conduct...

  • Medical Head, Neuroscience

    vor 1 Monat

    Perth, Österreich Novartis Farmacéutica Vollzeit

    Novartis, a renowned global pharmaceutical and healthcare company, is dedicated to improving patient outcomes and driving innovation in global health. With a rich history spanning over 250 years, Novartis has emerged as a leader in the industry, leveraging cutting-edge medical science and technological advancements to develop life-changing medications and...

  • Senior Product Manager

    vor 2 Monaten

    Perth, Österreich Biogen, Inc. Vollzeit

    Senior Product Manager (13-month Parental Leave Cover)Full-timeRegion: APACBiogen ANZ embraces an inclusive workplace environment and applicants of all backgrounds and experiences.The Senior Product Manager is responsible for the development, implementation, and execution of operational plans that optimize the commercial (revenue, market share, sales) growth...

  • Senior Product Manager

    vor 4 Wochen

    Perth, Österreich Biogen, Inc. Vollzeit

    Senior Product Manager (13-month Parental Leave Cover)Full-timeRegion: APACBiogen ANZ embraces an inclusive workplace environment and applicants of all backgrounds and experiences.The Senior Product Manager is responsible for the development, implementation, and execution of operational plans that optimize the commercial (revenue, market share, sales) growth...

  • Senior Adviser

    vor 4 Wochen

    Perth, Österreich National Offshore Petroleum Safety and Environmental Management Authority (NOPSEMA) Vollzeit

    The National Offshore Petroleum Safety and Environmental Management Authority (NOPSEMA) is Australia's independent expert regulator for health and safety, structural integrity, well integrity and environmental management for all offshore energy operations and greenhouse gas storage activities in Commonwealth waters and in coastal waters where regulatory...

  • Airport Reporting Officer

    vor 2 Wochen

    Perth, Österreich Cloncurry Shire Council Vollzeit

    Cloncurry Shire Council is seeking a Full time Airport Reporting Officer to join the team at the Cloncurry Airport.Benefits include:$71,800 to $75,800 per annum (dependent on qualifications/experience) + Superannuation -With overtime, total annual earnings generally average $100,000+ ( OT is not guaranteed )5 weeks Annual Leave(with 17.5% Leave...

  • Contracts Manager, Cowra

    Vor 2 Tagen

    Perth, Österreich Richard Crookes Constructions Pty Vollzeit

    Ready for a tree-change? We are hiring in Cowra, NSW.28th May, 2024Richard Crookes Constructions (RCC)is a leading, family-owned construction company that has been delivering quality projects across Australia for over 45 years. Our reputation for excellence, reliability, and integrity in the construction industry is built on our commitment to client...

  • Commissioning & Qualification (C&Q) Engineer

    vor 3 Wochen

    Perth, Österreich CSL - Australia Vollzeit

    Your RoleThe Process Engineering function at CSL Behring is recruiting multiple roles within ourCommissioning & Qualification (C&Q)team, these are permanent positions at our Broadmeadows site.You will apply fundamental engineering knowledge for the design and implementation of new process technology as part of our high priority expansion projects.You will...

  • Senior Commissioning and Qualification

    vor 1 Monat

    Perth, Österreich CSL - Australia Vollzeit

    Senior Commissioning and Qualification (C&Q) EngineerYour RoleThe Process Engineering function at CSL Behring is recruiting for multiple Senior Commissioning and Qualification (C&Q) Engineers to join our team at the Broadmeadows site.This is atwo year fixed termrole where you will apply fundamental engineering knowledge for the design and implementation of...