Senior Regulatory Affairs Specialist

vor 3 Stunden

Sydney, Österreich Merck Gruppe - Msd Sharp & Dohme Vollzeit

Job Description
Senior Regulatory Affairs Specialist – Animal Health Looking for a different challenge as a Senior Regulatory Affairs Specialist whereby you can utilise your skills?Permanent Full-time position with competitive remuneration and benefitsLocation: Sydney, Macquarie ParkHybrid, work from home and office environment, with a dedicated and welcoming teamJoin a growing, yet already successful marketUpskill and growth in an area you're passionate about, whilst being fully supported and encouragedJoin a trusted Global leading Animal Health organisationThe primary responsibility of the Senior Regulatory Affairs Specialist is to drive the development, importation, and registration of new products and to ensure internal and external regulatory compliance for the entire product range.
Of critical importance to the successful execution of this role is management of new product development and registration projects and for conducting routine regulatory operations to ensure compliance.
The Senior Regulatory Affairs Specialist sits within the Animal Health organisation and reports to the Regulatory Affairs Manager.
What You Will Do Responsibilities include, however not limited to: Regulatory Project Management Registration of new products – Review, compile and submit registration dossiers and data packages for agreed key projects, within timeframes agreed with manager and in accordance with government, industry and corporate requirements to maintain regulatory compliance and facilitate product supply.Product stewardship for existing portfolio, including providing regulatory support for additional claims, variations.Provide regulatory support to conduct research trials for new products or label extensions for existing products.Identify and communicate risks to approvals or timelines agreed as part of project planning.Propose options to address any technical / regulatory concerns as applicable.Support the development of the regulatory strategy for new technologies in Australia.
This will include liaising with Regulatory authorities in Australia with the view of gaining market access for these new technologies.Regulatory Compliance and Technical Support Provide regulatory and technical advice as requested to other parts of the organization to ensure that correct and compliant information is used in decision making and strategy development.Support of the Change Control process.Maintain relevant Permits and Licences.Ensure that our company's products comply with the regulatory and legal requirements set by the local regulatory authorities.Ensure all advertising, promotional and educational/technical materials that are related to products marketed comply with applicable local laws and regulations and consistent with all corporate and our company Animal Health's policies and standards, and reflects our company's Code of Conduct.Participate in PQC investigations and recall actions as required.Maintain all documentation in accordance with Company and relevant quality standards.Training Complete all training requirements, in accordance with company and relevant quality standards requirements.Attend relevant training courses as the opportunity presents.Ensure good housekeeping in the work area in accordance with company and relevant quality standards.
Pharmacovigilance Follow global and local procedures to ensure suspected adverse events are timely reported and meet the local legislative requirements.Ensure that all PV obligations relating to both internal local/global company processes AND Australian/ NZ regulatory requirements are met.For Specialists with PV back-up responsibility:Maintain a current local and Global PV training status (to National PV team level) - as directed by the local DPOCAssist with entry of local PV cases into PV Works as directed by your manager and in accordance with local and global PV procedures and timelinesWhat You Must have Graduate or Post-Graduate degree in relevant biological scienceSolid prior experience in regulatory affairsKnowledge of relevant Australian Regulatory SystemsDemonstrated regulatory experience with vaccines and biologicals highly desiredHighly developed skills in negotiating, influencing, leadership with excellent communication and organizational skillsUnderstanding of quality systemsAbility to analyse data.
Logical and analytical approach to problem solvingAbility to work well with other departments in a team setting.
Self-starter with initiative who works well with minimal supervisionAbility to work under pressure to meet deadlines and to make sound decisions on a day-to-day basis concerning regulatory affairsWhat You Can Expect Work autonomously whilst being supported, encouraged and being part of a trusted Global leading Animal Health organisationExposure to upskill and develop in your roleFlexibility and opening doors to other opportunities and skillsetsJoining a collaborative team of likeminded individualsWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together.
The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment.
We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
Current Employees apply HERE Current Contingent Workers apply HERE Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities.
All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company.
No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place.
Where agency agreements are in place, introductions are position specific.
Please, no phone calls or emails.
Employee Status:
RegularRelocation: VISA Sponsorship: Travel Requirements: Flexible Work Arrangements:
HybridShift: Valid Driving License: Hazardous Material(s): Job Posting End Date:
12/25/2024*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date.
Please ensure you apply to a job posting no later than the day BEFORE the job posting end date. Requisition ID:R323456
#J-18808-Ljbffr

  • Senior Regulatory Affairs Specialist

    vor 4 Stunden

    Sydney, Österreich Merck Sharp & Dohme Corp. Vollzeit

    Job DescriptionSenior Regulatory Affairs Specialist – Animal Health Looking for a different challenge as a Senior Regulatory Affairs Specialist whereby you can utilise your skills?Permanent Full-time position with competitive remuneration and benefitsLocation: Sydney, Macquarie ParkHybrid, work from home and office environment, with a dedicated and...

  • Merck Sharp

    vor 2 Stunden

    Sydney, Österreich Tideri Jobbörse Vollzeit

    Job Description Senior Regulatory Affairs Specialist – Animal Health Looking for a different challenge as a Senior Regulatory Affairs Specialist whereby you can utilise your skills?Permanent Full-time position with competitive remuneration and benefits Location: Sydney, Macquarie Park Hybrid, work from home and office environment, with a dedicated and...

  • Senior Specialist, Regulatory Affairs

    vor 1 Monat

    Sydney, Österreich Resmed Inc Vollzeit

    Senior Specialist, Regulatory Affairs (Hardware and Software) page is loadedSenior Specialist, Regulatory Affairs (Hardware and Software)Apply locations Sydney, NSW, Australia time type Full time posted on Posted 6 Days Ago job requisition id JR_038184Let's talk about the team:The Global Product Team is a dynamic, cross-functional group that drives the...

  • Senior Specialist, Regulatory Affairs

    vor 4 Wochen

    Sydney, Österreich Resmed Inc Vollzeit

    Senior Specialist, Regulatory Affairs (Hardware and Software) page is loadedSenior Specialist, Regulatory Affairs (Hardware and Software)Apply locations Sydney, NSW, Australia time type Full time posted on Posted 6 Days Ago job requisition id JR_038184Let's talk about the team: The Global Product Team is a dynamic, cross-functional group that drives the...

  • Senior Regulatory Affairs Associate

    vor 1 Monat

    Sydney, Österreich Stryker Vollzeit

    Together with our customers, we are driven to make healthcare better.#WeAreStrykerStryker Senior Regulatory Affairs Associate Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better.The company offers innovative products and services in Orthopaedics, Medical and Surgical, and...

  • Senior Regulatory Affairs Associate

    vor 1 Monat

    Sydney, Österreich Stryker Vollzeit

    This is a Senior Regulatory Affairs Associate role with one of the leading companies in AU right now 🔥 -- Stryker -- with an amazing team. They are continuing to grow rapidly. This is the chance to join right as the 🚀 takes off.More About the Role at Stryker 🧐🧐### Job description If you are passionate about medical devices and regulatory affairs,...

  • Regulatory Affairs Specialist

    vor 8 Stunden

    Sydney, Österreich Hobson Prior International Ltd Vollzeit

    Hobson Prior is seeking a Regulatory Affairs Specialist to join our client's team in Sydney.In this role, you will focus on ensuring that product listings comply with Australian regulations and manage applications for new product approvals.This is a great opportunity for someone who is detail-oriented and enjoys working with regulatory processes.Please note...

  • Senior Regulatory Affairs Associate

    vor 3 Wochen

    Sydney, Österreich Stryker Vollzeit

    Work Flexibility: HybridIf you are passionate about medical devices and regulatory affairs, then Stryker wants to talk to you. We are looking for a Senior Regulatory Affairs Associate to join the high-performing regulatory team. The successful candidate will bring experience to complement the existing RA team of four.We are looking for someone who has at...

  • Senior Regulatory Affairs Associate

    vor 9 Stunden

    Sydney, Österreich Stryker Group Vollzeit

    If you are passionate about medical devices and regulatory affairs, then Stryker wants to talk to you.We are looking for a Senior Regulatory Affairs Associate to join the high performing regulatory team.The successful candidate will bring experience to complement the existing RA team of four.We are looking for someone who has at least 5 years' experience...

  • Regulatory Affairs Specialist

    Vor 4 Tagen

    Sydney, Österreich Hobson Prior International Ltd Vollzeit

    Hobson Prior is seeking a Regulatory Affairs Specialist to join our client's team in Sydney.In this role, you will focus on ensuring that product listings comply with Australian regulations and manage applications for new product approvals.This is a great opportunity for someone who is detail-oriented and enjoys working with regulatory processes.Please note...

  • Senior Regulatory Affairs Associate

    vor 3 Wochen

    Sydney, Österreich Astrazeneca Vollzeit

    Pharmaceuticals & Medical Devices (Healthcare & Medical) Full time Do you have expertise in regulatory affairs and passion for seeing the safe and effective use of pharmaceutical medicines for patients?Would you like to apply your expertise to help turn our pipeline into reality?Then AstraZeneca might be the one for you!ABOUT ASTRAZENECA AstraZeneca is a...

  • Senior Regulatory Affairs Associate

    Vor 6 Tagen

    Sydney, Österreich Stryker Vollzeit

    This is a Senior Regulatory Affairs Associate role with one of the leading companies in AU right now 🔥 -- Stryker -- with an amazing team. They are continuing to grow rapidly. This is the chance to join right as the 🚀 takes off.More About the Role at Stryker 🧐🧐### Job description If you are passionate about medical devices and regulatory affairs,...

  • Senior Specialist, Regulatory Affairs

    vor 2 Wochen

    Sydney, Österreich Resmed Vollzeit

    Let's talk about the team:The Global Product Team is a dynamic, cross-functional group that drives the development and innovation of our products across multiple regions, with a primary focus within our Sydney and Singapore offices. This team is responsible for overseeing the entire product lifecycle, from ideation through development, and ensuring that both...

  • Astrazeneca | Senior Regulatory Affairs Associate

    vor 3 Wochen

    Sydney, Österreich Tideri Jobbörse Vollzeit

    Pharmaceuticals & Medical Devices (Healthcare & Medical) Full time Do you have expertise in regulatory affairs and passion for seeing the safe and effective use of pharmaceutical medicines for patients?Would you like to apply your expertise to help turn our pipeline into reality?Then AstraZeneca might be the one for you!ABOUT ASTRAZENECA AstraZeneca is a...

  • Stryker | Senior Regulatory Affairs Associate

    vor 3 Wochen

    Sydney, Österreich Tideri Jobbörse Vollzeit

    Work Flexibility: Hybrid If you are passionate about medical devices and regulatory affairs, then Stryker wants to talk to you.We are looking for a Senior Regulatory Affairs Associate to join the high-performing regulatory team.The successful candidate will bring experience to complement the existing RA team of four.We are looking for someone who has at...

  • Resmed Inc | Senior Specialist, Regulatory Affairs

    vor 4 Wochen

    Sydney, Österreich Tideri Jobbörse Vollzeit

    Senior Specialist, Regulatory Affairs (Hardware and Software) page is loadedSenior Specialist, Regulatory Affairs (Hardware and Software) Apply locations Sydney, NSW, Australia time type Full time posted on Posted 6 Days Ago job requisition id JR_038184Let's talk about the team: The Global Product Team is a dynamic, cross-functional group that drives the...

  • Resmed | Senior Specialist, Regulatory Affairs

    vor 2 Wochen

    Sydney, Österreich Tideri Jobbörse Vollzeit

    Let's talk about the team: The Global Product Team is a dynamic, cross-functional group that drives the development and innovation of our products across multiple regions, with a primary focus within our Sydney and Singapore offices.This team is responsible for overseeing the entire product lifecycle, from ideation through development, and ensuring that both...

  • Stryker | Senior Regulatory Affairs Associate | Sydney

    vor 1 Monat

    Sydney, Österreich Tideri Jobbörse Vollzeit

    Together with our customers, we are driven to make healthcare better.#WeAreStryker Stryker Senior Regulatory Affairs Associate Stryker is one of the world's leading medical technology companies and, together with its customers, is driven to make healthcare better.The company offers innovative products and services in Orthopaedics, Medical and Surgical, and...

  • Associate Director, Regulatory Affairs

    vor 3 Monaten

    Sydney, Österreich Pharmalex Gmbh 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, market development, and effective...

  • Associate Director, Regulatory Affairs

    vor 3 Monaten

    Sydney, Österreich Pharmalex Gmbh 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, market development, and effective...