Regulatory Affairs Manager X 2 Contracts

7 months ago

Melbourne, Australia Peritus Recruitment Full time

**You must have relevant Australian Work Rights to be considered.**

**Job Details**:

- Two contract positions available for 6 months but could go longer.
- Based at Melbourne CBD HQ
- Team size: 6 people
- Flexibility?: 1-3 days/week at office; balance WFH
- Hours: 38/week (incl some early morning or late evening calls) - occasional OT - flexible
- If the Person works more than 38 hours in the week, are you prepared to pay penalty rates for overtime? N/A - Daily rate
- Potential to extend beyond 6 months: Yes. Likely

**Essential Qualifications**:

- Tertiary qualified in biological science, allied medical discipline or pharmacy, preferably with a Masters or PHD or complementary experience in a pharmaceutical/biotechnology industry

**Essential Skills/Experience**:

- A minimum of 7 years’ experience in regulatory affairs in any of the above industries working within the Asia Pacific region
- Prior regulatory experience in vaccines
- Fluent in English (written and verbal)
- Strong, positive, established relationships with local Health Authorities
- Flexibility and ability to work effectively within a global organisation comprising a range of different functional areas and cultures;
- Strong customer focus;
- Commitment to achieving objectives in a complex matrix environment;
- Highly developed organisation skills including planning and time management;
- Problem solving and analytical skills supported by good attention to detail;
- Knowledge of device requirements would be a distinct advantage.

**Job Summary**
This is a role in the Regulatory Affairs, AsiaPac Regions team; providing regulatory support for the clients manufactured products within the Asia Pacific markets.

A specialist role within our Global Regulatory Affairs group has become available. This role is for an experienced Regulatory professional and includes working on all the clients manufactured products across the Asia Pacific region. As part of this close knit expert team you will:

- Actively contribute to and support the formulation and implementation of the regional regulatory strategy for clients manufactured products including product development and complex technical changes
- Assist in providing Asia Pacific regional expertise to ensure dossiers and regulatory submissions meet content requirements for applicable territories, including negotiating with relevant Health Authorities as required
- Ensure that all regulatory agency correspondence and submissions are managed within the relevant databases and tracked to ensure regulatory compliance;
- In collaboration with Global Strategic Labelling assist in the maintenance of up to date product labelling for all relevant the clients territories including translation requirements
- Establish and maintain strong and collaborative working relationships with National Regulatory Agencies across the region.

  • Regulatory Affairs Officer

    6 months ago

    Melbourne, Australia Bell People Consultants Full time

    Global Pharmaceutical Manufacturing Organisation - Long Term Contract Opportunity - Melbourne Metropolitan Area **About the Organisation** Operating as a progressive and highly respected pharmaceutical manufacturing organisation, our client is well known for its operational excellence, passion for innovation and its household quality branded products. An...

  • Regulatory Affairs Officer

    6 months ago

    Melbourne, Australia Healthcare Professionals Group Full time

    **Benefits** - Must have unrestricted work rights for 12 months - Working within a global team - Monday to Friday only **About the company** Work within a large global Biotechnology company that boasts a good company culture that is always expanding. **About the opportunity** The Regulatory Affairs Officer will provide technical and administrative...

  • Regulatory Affairs Officer, Mat Leave Contract, Csl

    6 months ago

    Melbourne, Australia Peritus Recruitment Full time

    **Contract Detail**: - Duration of role - 12 months initially but could go longer - To start asap but will wait for right person - Reason for vacancy? Maternity Leave Backfill - Role reports to (title)? Associate Director, Regulatory Regional ANZ TA Lead - Department? Global Regulatory Affairs - Team size? Immediate team of 4, but will work across different...

  • Regulatory Affairs Professional

    2 weeks ago

    Melbourne, Victoria, Australia Gilead Sciences Full time

    Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercialises innovative medicines in areas of unmet medical need. With each new drug discovery and investigational candidate, we seek to improve the care of patients living with life-threatening diseases around the world.As a Senior Manager, Regulatory Affairs at...

  • Regulatory Affairs Manager

    6 months ago

    Melbourne, Australia Fuse Recruitment Full time

    **Melbourne VIC** **APPLY NOW!** **Full time** **We are looking for an experienced Regulatory Affairs Manager to join our client’s organisation!** Our client is a rapidly expanding MedTech innovator and manufacturer. As they go from strength to strength, demand for innovative product development has driven the need for a Regulatory Affairs Manager to...

  • Regulatory Affairs Manager

    7 months ago

    Melbourne Eastern Suburbs, Australia HAYS Full time

    Regulatory Affairs Manager for global medical device company based in Melbourne. **Your new company** This is a global medical device/diagnostic company based in Melbourne looking for a Regulatory Affairs Manager to join there team and support global registrations. **Your new role** Your new role will be managing a team of regulatory professional and...

  • Regulatory Affairs Associate

    6 months ago

    Melbourne, Australia u&u Recruitment Partners Full time

    About the company Our client is a ASX global pharmaceutical company recognised as the pioneers of treatments for patients with a variety of life-threatening disorders. About the role The Regulatory Affairs Associate will support the Regulatory Team in: Obtain regulatory approvals globally for designated product portfolio; Manage national regulatory...

  • Regulatory Affairs Associate

    6 months ago

    Melbourne, Australia u&u Recruitment Partners Full time

    About the company Our client is a ASX global pharmaceutical company recognised as the pioneers of treatments for patients with a variety of life-threatening disorders. About the role The Regulatory Affairs Associate will support the Regulatory Team in: Obtain regulatory approvals globally for designated product portfolio; Manage national regulatory...

  • Regulatory Affairs Manager, Global Compliance

    4 weeks ago

    Melbourne, Victoria, Australia Gilead Sciences Full time

    Gilead Sciences is a research-based biopharmaceutical company committed to creating innovative medicines for unmet medical needs. Our team in Melbourne, Australia, is seeking a highly skilled Regulatory Affairs professional to join our cross-functional department.Job DescriptionThis 12-month contract role will report to the Senior Director, Regulatory...

  • Regulatory Affairs 12 Month Contract

    6 months ago

    Melbourne, Australia Peritus Recruitment Full time

    Our client is a leading biotech flu market leader based at Parkville. They require a Regulatory Affairs expert for a twelve (12) month contract (req no 21735). Note the contract is very likely to go longer if agreed by both parties. The require someone asap but will wait for the right person to provide notice in current role etc as required. If interested,...

  • Regulatory Affairs Specialist

    7 months ago

    Melbourne, Australia Bell People Consultants Full time

    Global Pharmaceutical Manufacturing Organisation - Regulatory Support for Products within Asia Pacific Markets - Melbourne Metro Area - Hybrid Role - WHF & Site based **About the Company**: Operating as a progressive and highly respected pharmaceutical manufacturing organisation, our client is well known for its operational excellence, passion for...

  • Regulatory Affairs Specialist

    1 month ago

    Melbourne, Victoria, Australia DoorDash, Inc. Full time

    About DoorDashWe're a technology and logistics company that empowers local economies by providing fast, reliable, and affordable delivery services to consumers. Our mission is to make it possible for anyone to get what they need in under an hour.Job OverviewWe're looking for a highly skilled Regulatory Affairs Specialist to join our Policy Development and...

  • Manager - Regulatory Affairs

    7 months ago

    Melbourne, Australia ProductLife Group Full time

    Specific Activities and Responsibilities: Must have expertise in Health Authority communications for Initial filings, LCM Activities and for variation submissions. Must have experience and thorough knowledge of the process of submissions at HA without missing any detail or deadline. Must be competent with the current changes and regulations from the...

  • Regulatory Affairs Expert in Melbourne

    3 weeks ago

    Melbourne, Victoria, Australia Gilead Sciences Full time

    Gilead Sciences is a research-based biopharmaceutical company that discovers, develops, and commercializes innovative medicines in areas of unmet medical need. Our mission requires collaboration, determination, and a relentless drive to make a difference.As a knowledgeable professional, you will play a critical role in the discovery and development of...

  • Product Support and Regulatory Affairs

    6 months ago

    Melbourne, Australia KE Select Full time

    Product support. - Regulatory Affairs - Chemicals **The Company** This company has been a leading distributor in the medical, pharmaceutical, and scientific industries for the last 20 years. They are proud to be delivering high quality technology to the Life Science community in ANZ. **About the role** This is an new opportunity located in VIC. As the...

  • APAC Trade Regulatory Affairs Manager

    2 weeks ago

    Melbourne, Australia Mars Incorporated Full time

    JOB DESCRIPTIONJob Description:Regulatory Affairs maximizes opportunities & minimizes risk by guiding business decisions based on regulatory insight and provide appropriate governance structures.What are we looking for?APAC factories produces a considerable volume of Royal Canin products to expand its cover into other regions in APAC and more....

  • Manager - Pharmaceutical Regulatory Affairs

    6 months ago

    Melbourne, Australia Seqirus A CSL Company Full time

    A permanent, full-time role within our Global Regulatory Affairs group has become available. This role is for an experienced Regulatory professional and includes working on all CSL Seqirus manufactured products across the Asia Pacific region. This includes influenza vaccines and Products of National Significance (PNS) including snake/spider...

  • APAC Trade Regulatory Affairs Director

    2 weeks ago

    Melbourne, Victoria, Australia Mars Incorporated Full time

    Company Overview:Mars Incorporated is a global leader in the pet food industry, striving to build a better world for pets and people alike. Our commitment to innovation, quality, and sustainability drives our business forward. About the Role:We are seeking an experienced APAC Trade Regulatory Affairs Director to join our team in this critical role. The...

  • Regulatory Affairs Specialist for Risk Management

    3 weeks ago

    Melbourne, Victoria, Australia 023 Northern Trust Company Australia Full time

    About Northern Trust Company AustraliaAs a leading global financial institution, Northern Trust is committed to delivering innovative solutions and expert guidance to its clients.Northern Trust has been in operation since 1889, serving the world's most sophisticated individuals, families, and institutions with exceptional service and integrity.The company's...

  • Regulatory Affairs Specialist

    6 months ago

    Melbourne, Australia ProductLife Group Full time

    Specific Activities and Responsibilities: Must have expertise in Health Authority communications for Initial filings, LCM Activities and for variation submissions.Must have experience and thorough knowledge of the process of submissions at HA without missing any detail or deadline.Must be competent with the current changes and regulations from the HA.Will be...