Senior Regulatory Affairs Specialist

Pracovní nabídka

What is waiting for you

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.

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 specific regulations, 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.

What skills and knowledge should you posses

• 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

What can we offer

At Emmes, your actions and hard work will have a direct impact on public health initiatives, both globally and in our local communities with opportunities for volunteerism through our Emmes Cares community engagement program. We offer a competitive benefits package focused on the health and needs of our growing workforce, including:

• Flexible Approved Time Off
• Meal Allowance
• Group Benefits Premiums
• Multisport Card with Employer contribution
• Occasional Work from Home or Fully Remote Options
• Allianz Group Life Coverage
• Wellness Program
• English Lessons