Description
Line Manager, Regulatory Affairs, EU remote, Spain, Poland or Germany,
This role combines people leadership and operational delivery, actively contributing to the execution of clinical trial regulatory activities.
As a Line Manager & Regulatory Affairs Specialist, the employee will be responsible of overseeing Ethics Committee (EC), Regulatory Authority (RA), and other submissions created within or outside of the company to ensure submissions comply with applicable regulations and contractual timelines are met. The Regulatory Affairs Specialist will provide leadership for assigned projects regarding all regulatory activities that lead to startup of clinical trials. As Line Management, the employee will be responsible for resource management and team development of direct reports.
More specifically, the Line Manager, Regulatory Affairs/ Regulatory Affairs Specialist must:
- Coordinates regulatory timelines and deadlines for all assigned projects planned for RA and EC submissions.
- Provides regulatory support and advice to project teams; provides project-specific local submission strategy and technical expertise.
- Provide guidance to the client on submissions strategies.
- Prepares/reviews core packages and country packages for submission to RA (initial applications, amendment packages, and notifications) in assigned countries to ensure compliance.
- Prepares, manages, and tracks IRB/IEC submissions (including renewals); acts as the primary point of contact for the central IRB/IEC.
- Peer review of documents and packages prepared by colleagues within regulatory team.
- Reviews regulatory documents and submissions created outside of the company by subcontractors (e.g., partner CROs, regulatory vendors) to ensure high quality standards before submission to RA and IEC.
- Point of contact for regulatory body and IRB/IEC, Sponsors, investigative sites, subcontractors, and local teams for all aspects related to study regulatory submissions.
- Develops/reviews Master Informed Consent Form (ICF), as applicable, and Country ICFs.
- Reviews site-level Informed Consent form documents as needed.
- Prepares or reviews study-specific regulatory documents/forms.
- Manages/oversees translations and requests with vendor.
- Submits and tracks SUSARs to RA, EudraVigilance, IRB/IEC, and Investigators, as per study scope.
- Performs regulatory review of essential documents and authorizes regulatory release prior to the shipment of investigational product to clinical sites.
- Reviews country-specific labelling content for clinical trial drug supplies to ensure conformity with regional regulations requirements.
- Participates in Kick-off meetings, client audits, and other project related meetings according to the company / client needs
- Submits documents to TMF in a timely manner during the trial and ensures the TMF is complete for assigned sections by performing completeness reconciliation.
- Communicates activities performed out-of-scope to project team members and provides them with budgeting details related to said activity.
- Maintain high level knowledge about regulations in the area of company interest
- Participates in function and/or corporate initiatives and special project assignments
- Support Regulatory Country Intelligence activities
- Communicate/liaise with regulatory agencies/competent authorities and/ or other regulatory or functional experts on designated regulatory activities as required
- May provide presentations, training or helps to develop tools and processes for the Regulatory Team or other cross-functional teams.
Line Management:
- Provide line management to direct reports, including new-hire orientation, professional development, performance appraisals, and employee counseling/mentoring.
- Management and coordination of resources and workloads of direct reports.
- Supports staff by establishing goals that will increase knowledge and skill levels and by delegating tasks commensurate with skill level
- Promote a positive work environment and motivate the team to achieve organisation goals.
- Participate in the hiring process of new employees.
- Provide leadership and implement productivity improvements to ensure optimal utilisation of resources. Participate in process improvement initiatives.
Employee may be assigned to other responsibilities that do not pertain to their former description, if they have the required experience, are qualified and/or have received adequate training.
Requirements
Education:
- Bachelor’s degree (or equivalent) in a scientific discipline.
Experience:
- 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. Working knowledge of applicable regional / national country regulatory guidelines, IRB/IEC regulations
Knowledge and skills
- EU: Knowledge knowledge of CTIS on a local and regional level
- Functional staff management experience an asset.
- Ability to develop skills of others and motivate team members
- Excellent communication skills
- Excellent knowledge of Microsoft Office suite
- 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
- Respect established timelines, expectations, priorities, and objectives
- Good knowledge of good clinical practices, applicable Health Canada and Food and Drug Administration (FDA), and Regulation (EU) No 536/2014.
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:
- Permanent full-time position
- Flexible schedule
- Vacation
- Home-based position
- Ongoing learning and development
About Indero
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 Europe.
Description de poste
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Profil recherché
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Notre entreprise
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