Regulatory Affairs Specialist

2 weeks ago

Sydney, New South Wales, Australia Bi Australia Part time

**The Position**:
Reporting to the **Head of Regulatory Affairs, AUNZ **, an exciting opportunity has arisen for a part-time **Regulatory Affairs Specialist **to come and join our high performing team

Your role will be to develop, execute and maintain regulatory strategies for submissions in order to obtain/maintain regulatory approvals and regulatory compliance for assigned product(s) in line with Business strategies.

**Tasks & Responsibilities**:

- Analyze and/or assist in the analysis of scientific content of registration packages
- Prepare and submit regulatory submissions to the TGA/Medsafe or other associated regulatory bodies
- Review and approve artwork and packaging changes and recommend action
- Resolve regulatory issues/opportunities for improvement by problem solving and collaboration with local, regional and corporate colleagues
- Keep up to date with government legislation as it relates to regulatory/ scientific affairs
- Actively train less experienced team members in regulatory related tasks, where appropriate
- Develop relationships with global and regional RA colleagues, including attending telecons with global and regional RA staff and participating in global activities where required

**Requirements**:

- Bachelor's Degree - Pharmacology/Pharmacy, Biomedical or related field
- Minimum of 3 years of experience in regulatory affairs with hands on Prescription Medicine experience writing a submission using the EU dossier
- Keen attention to detail
- Advanced computer skills, including competency in electronic submissions
- Highly developed written and verbal communication skills
- Ability to understand and communicate complex chemistry, non-clinical and clinical information to internal and external stakeholders
- Good relationship building skills, able to engage, communicate and negotiate effectively with customers and colleagues
- Good understanding of local regulatory regulations, with the ability to interpret requirements and engage in RA-related discussions with local, regional and global colleagues
- High standard of interpersonal skills, including the ability to mentor individuals, and collaborate with local, regional and global colleagues
- Strong planning and time management skills
- Customer-focused approach

**What we offer**:
Boehringer Ingelheim offers a competitive remuneration and industry-leading lifestyle benefits including health insurance and a free and confidential Employee Assistance Program.

Boehringer Ingelheim offers a competitive remuneration, attractive bonus scheme, health insurance, employee assistance program, development programs and career development opportunities.

If you would like to be part of this highly driven and successful team, please submit your CV and a covering letter addressing the key criteria above.

You must have the right to live and work in this location to be considered for this opportunity.

Thank you for taking the time to consider a career opportunity with Boehringer Ingelheim. As part of our efforts toward continuous process improvement, you may receive a short survey pertaining to this recruitment process. We really appreciate your honest feedback. Thank you.

It is Boehringer Ingelheim'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.

**Position Area**:
Human Pharma

**Position Location**:
New South Wales

**Organization**:
BI - Australia

**Schedule**:
Full Time

**#LI-BI**:

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $100,000 - $120,000

    Job SummaryClinical professionals looking to develop their expertise in regulatory affairs will find this role a stimulating challenge. We seek a detail-oriented and highly motivated Regulatory Affairs Specialist to support our team.Key Responsibilities:Support the preparation and submission of regulatory documents.Maintain accurate records and provide...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $104,000 - $130,878

    Regulatory Affairs SpecialistThe Regulatory Affairs Specialist is responsible for overseeing and driving key regulatory activities, ensuring compliance with relevant regulations and legislation.This role bridges strategic and operational regulatory functions, aligning activities with business outcomes while serving as a subject matter expert and point of...

  • Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $80,000 - $120,000

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our team. This role will be responsible for supporting regulatory affairs activities for assigned products in Australia and New Zealand.Main Responsibilities:Support Regulatory Activities: Ensure compliance with all relevant regulations while assisting in developing strategies...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $150,000 - $200,000

    Job Opportunity: Regulatory Affairs SpecialistWe are seeking a skilled Regulatory Affairs Specialist to drive regulatory strategy and manage compliance in Australia and New Zealand.This role will involve monitoring legislative developments, providing advice and support to internal stakeholders on legal and regulatory matters, and operationalising regulatory...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia beBeeCompliance Full time $80,000 - $120,000

    Regulatory Affairs SpecialistWe are seeking a skilled professional to support regulatory submissions and strategic projects across our diverse portfolio.About the RoleSupport regulatory submissions related to clinical trials, GMP, medicine shortages, and medical devices.Assist with data entry, documentation, and administrative tasks.Collaborate with internal...

  • Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $125,000

    Job Title: Regulatory Affairs Specialist">Sydney Based Role:">We are seeking a highly skilled and experienced Regulatory Affairs Specialist to join our team in Sydney. As a key member of our Asia business, you will be responsible for managing the regional and compliance frameworks of multiple products.">Key Responsibilities:">Determining requirements (local,...

  • Regulatory Affairs Specialist

    1 week ago

    Sydney, New South Wales, Australia Medella Life Full time

    Location- Sydney- Contact name:- Ethan Keating- Job ref:- 827- Published:- about 2 hours ago**Job Title: Regulatory Affairs Specialist (12-month Contract)****Location: Hybrid - Sydney, Australia****Key Responsibilities**:- **Regulatory Compliance**:- Ensure compliance with relevant regulatory standards and guidelines in the Medical Device sector, with a...

  • Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $90,000 - $120,000

    Job Title: Regulatory Affairs SpecialistThis position is ideal for a detail-oriented individual with a passion for regulatory affairs in the cosmetics industry.Key Responsibilities:Build and maintain a master database of products to ensure compliance with the Australia Industrial Chemical Introduction Scheme (AICIS).Collaborate with marketing, supply, and...

  • Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $150,000 - $200,000

    Regulatory Affairs Specialist WantedJob Description:We are seeking an experienced Regulatory Professional to join our team in Australia. The successful candidate will have the opportunity to work with a broad range of clients, predominantly in the pharmaceutical and healthcare sectors.In this role, you will be responsible for ensuring appropriate licensing,...

  • Regulatory Affairs Specialist

    2 weeks ago

    Sydney, New South Wales, Australia beBeeRegulatory Full time $80,000 - $150,000

    Regulatory Affairs SpecialistWe are seeking a skilled Regulatory Affairs professional to drive innovation and develop new products for our major brands.The ideal candidate will have 3-4 years' experience in a similar role, a degree in a scientific field, and experience within the consumer goods industry. They will also have exposure to cosmetics, medical...