Senior Regulatory Affairs Specialist

Overview:

Senior Regulatory Affairs Specialist

Prague, Czech Republic OR Bratislava, Slovakia

Emmes Group: Building a better future for us all.

Emmes Group is transforming the future of clinical research, bringing the promise of new medical discovery closer within reach for patients. Emmes Group was founded as Emmes more than 47 years ago, becoming one of the primary clinical research providers to the US government before expanding into public-private partnerships and commercial biopharma. Emmes has built industry leading capabilities in cell and gene therapy, vaccines and infectious diseases, ophthalmology, rare diseases, and neuroscience.

We believe the work we do will have a direct impact on patients' lives and act accordingly. We strive to build a collaborative culture at the intersection of being a performance and people driven company. We're looking for talented professionals eager to help advance clinical research as we work to embed innovation into the fabric of our company. If you share our motivations and passion in research, come join us

Primary Purpose

The Senior Regulatory Affairs Specialist is responsible for leading the preparation of regulatory submissions to European countries via the Clinical Trials Information System (CTIS) and other electronic formats ie UK submissions. This includes leading document preparation, uploading into CTIS, and submission planning and tracking tasks. Good knowledge and hands-on experience of CTIS is essential.

Responsibilities:

• The Senior Regulatory Affairs Specialist is responsible for local post marketing activities:

• Experience with post-marketing regulatory activities for the local markets

• Experience with variation classification and review of required submission documents
• Communication with national regulatory authorities (e.g., SÚKL), Ethics Committees and other regulatory bodies
• Preparation and generation of proofs of payment for submissions
• Review of promotional materials to ensure regulatory compliance
• Revision and translation of product information (SmPC, PIL, labelling) and mock ups

• Solid understanding of the specific regulatory requirements in the local market

• Ensures that regulatory documents and electronic submissions are prepared in accordance with internal processes, client preferences, and EMA requirements.

• Creates and compiles submission dossiers, tracks submissions, manages RFIs and other reports for submissions such as amendments, end of trial notifications etc
• Performs QC review of prepared documents and compiled electronic submissions.
• Liaises with internal and external stakeholders to ensure the accuracy and timeliness of submission documents.
• Participates in or leads meetings with internal and external stakeholders regarding upcoming submissions.
• Assists department leadership with the development of submission schedules in accordance with internal or client timelines.
• Tracks and updates internal and external stakeholders on regulatory submission deliverables.
• Ensures timely updates to scheduled and completed submissions in the regulatory submission tracking database.
• Contributes to or leads the development and maintenance of internal tools and processes.
• Maintains and applies a competent knowledge of EMA and country specificregulations, guidance documents, and corporate/industry best practices.
• Identifies process or technical issues and proposes solutions to improve efficiency, quality, and/or compliance.
• Assists leadership in completing other department or corporate initiatives.
• Performs other duties as assigned.

Qualifications:

• Minimum of a bachelor's degree, preferably in a related discipline (Regulatory Affairs, Biomedical, etc.) and 6 years of related experience, or master's degree in a related discipline and a minimum of 5 years of related experience.At least 5 years of relevant experience
• Working knowledge of CTA submission components and organization of the Clinical Trial Application dossier.
• Excellent verbal and written communication skills including English and Czech (Slovak would be desirable but not essential)
• Proficiency in MS Word and Adobe Acrobat.
• Ability to work independently with minimal supervision, as well as in a team environment.
• Strong organizational and planning skills.
• Excellent time management skills, with ability to manage competing priorities.
• Ability to build and maintain positive relationships with peers, client contacts, and leadership.
• Strong analytical and problem-solving skills

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