Senior Regulatory Affairs Specialist

Job not on LinkedIn

🔥 24 minutes ago

🇦🇺 Australia – Remote

⏰ Full Time

🟠 Senior

🚔 Compliance

👻 Ghost score 12%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Innovaderm Research Inc.

WebsiteLinkedInAll Job Openings

201 - 500 employees

💊 Pharmaceuticals

🏥 Healthcare

💼 Consulting

Pharmaceuticals • Healthcare • Consulting

Innovaderm Research Inc. is a Contract Research Organization (CRO) specialized in dermatology, providing scientific guidance and conducting Phase I to IV clinical trials in the field. With a strong presence in North America and Europe, Innovaderm offers a comprehensive range of services including study design, regulatory consulting, project management, patient recruitment, and data management, ensuring high-quality research outcomes and customer satisfaction since 2000.

📋 Description

• Provide leadership for assigned projects involving regulatory activities leading to clinical trial startup • Oversee global/multinational complex large clinical trial submissions • Provide sponsor-facing regulatory leadership and manage regulatory deliverables within a country, region, or globally • Support the Associate Director Regulatory Affairs on special projects, process improvement initiatives, employee training, and company initiatives • Coordinate regulatory timelines and deadlines for RA and EC submissions • Lead global/multinational submissions of complex large clinical trials • Address sponsor queries regarding regulatory and submission requirements • Provide regulatory support, advice, local submission strategy, and technical expertise to project teams • Prepare and review core and country submission packages, including initial applications, amendment packages, and notifications • Peer review documents and packages prepared by regulatory colleagues • Develop and review Country ICFs • Review essential documents and authorize regulatory release before investigational product shipment to clinical sites • Develop and review country-specific clinical trial drug labelling • Participate in kick-off meetings, client audits, and project-related meetings • Mentor new or junior regulatory colleagues, including assigning work, coaching, training, and developing tools and processes • Support Regulatory Country Intelligence activities

🎯 Requirements

• Bachelors' degree (or equivalent) in a scientific discipline; Regulatory Affairs is an asset • 3–5 years in clinical regulatory affairs in the pharmaceutical, biotechnology and/or CRO industry • Experience preparing and submitting IRB/IEC packages and/or Clinical Trial Applications • Strong understanding of global regulatory requirements and guidelines in assigned countries/regions • Experience in a global leadership role focused on Europe and APAC regulatory regions, including Australia/New Zealand • Experience with the regulatory process under EU-CTR • Fluency in English with excellent oral and written skills, required • Additional languages represent an asset • Attention to detail and accuracy in work • Ability to organize own work, prioritize different assignments, and work under pressure • Versatile and comfortable in a multitasking environment • Ability to respect established timelines, expectations, priorities, and objectives • Must be legally authorized to work in Australia

🏖️ Benefits

• Flexible work schedule • Permanent full-time position • Complete benefits (medical, dental, vision, RRSP, vacation, personal days, virtual medical clinic, public transportation rebates, social activities) • Ongoing learning and development • Attractive advancement opportunities