The Senior Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials and will oversee global/multinational complex large clinical trial submissions.
This role will be responsible for sponsor-facing regulatory leadership and management of regulatory deliverables within a country, region or globally. This role will also support the Associate Director Regulatory Affairs in special projects, process improvement initiatives, training of new employees and company initiatives.
RESPONSABILITIES
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Coordinates regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions. Lead global/multinational submissions of complex large clinical trials.
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Addresses Sponsor queries related to regulatory and submission requirements.
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Provides regulatory support and advice to project teams; provides project-specific local submission strategy and technical expertise.
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Prepares/reviews core packages and country packages for submission to RA (initial applications, amendment packages, and notifications) in assigned countries to ensure compliance.
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Peer review of documents and packages prepared by colleagues within regulatory team.
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Develops/reviews Country ICFs.
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Performs regulatory review of essential documents and authorizes regulatory release prior to the shipment of investigational product to clinical sites.
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Develops/reviews country-specific labelling content for clinical trial drug supplies to ensure conformity with regional regulations requirements.
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Participates in Kick-off meetings, client audits, and other project related meetings according to the company / client needs
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Act as a mentor to new or junior colleagues within regulatory team. Responsibilities could include helping in assigning work; coaching/training; providing instructions; developing tools and processes to help daily work; helping in maintaining high quality of work of regulatory/ethics submissions
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Support Regulatory Country Intelligence activities
Requirements:
- Bachelors' degree (or equivalent) in a scientific discipline. Regulatory Affairs is an asset
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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
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Strong understanding of global regulatory requirements and guidelines in assigned countries / regions.
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Experience in global leadership role with a focus on regulatory regions such as Europe and APAC (Australia/New Zealand). Experience of the regulatory process under EU-CTR.
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Fluency in English with excellent oral and written skills, required
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Additional languages represent an asset
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Attention to detail and accuracy in work
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Ability to organize own work, prioritize different assignments, and work under pressure
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Versatile and comfortable in a multitasking environment
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Respect established timelines, expectations, priorities, and objectives
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Good knowledge of good clinical practices, applicable Health Canada and Food and Drug Administration (FDA), and Regulation (EU) No 536/2014.
Brand name:
Indero
Our company:
The work environment
At Indero, you will work with brilliant and driven colleagues. Our values are collaboration, innovation, reliability and responsiveness. We offer a stimulating work environment and attractive advancement opportunities.
In this position, you will be eligible for the following perks:
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Flexible work schedule
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Permanent full-time position
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Company benefits package
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Ongoing learning and development
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Home-based position
Work location
Note that this opening is for a home-based position in India. Attendance at some meetings outside of regular business hours (primarily in the evening) is required.
About Indero
A Global Clinical Leader in Dermatology and rheumatology!
Formerly known as Innovaderm, Indero is a world-renowned expert and clinical research leader in dermatology. We have more than two decades of experience serving a broad range of indications, patient populations, administration routes, and drug classes, and a global footprint.
Indero is a dual-focus CRO for dermatology and rheumatology, with 25+ years’ experience in clinical research and trial delivery. Our full-service approach – which includes everything from protocol design and patient recruitment to trial monitoring and biometrics – provides biotech and pharmaceutical sponsors with the rigorous scientific foundation and tailored expertise their studies need to reach the finish line efficiently and effectively. With capabilities in North America, Europe, Asia Pacific and Latin America; vast, continuously growing relationships with investigators and patients; and a dedicated research clinic through which we design and execute our own studies, Indero is the ideal CRO partner for clinical needs at global scale.
Indero is committed to providing equitable treatment and equal opportunity to all individuals. As such, Indero will provide accommodations throughout the recruitment and selection process to applicants with disabilities, upon request.
Indero only accepts applicants who can legally work in Germany.
