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Regulatory Affairs Manager - Pharma/Medical Device

Meditrial Europe Ltd.
Berlin

Jetzt bewerben

Details zur Stelle

Vollzeit

Qualifikationen

Microsoft Powerpoint
Microsoft Word
Microsoft Excel
Microsoft Outlook
Doktorat
Englisch
Microsoft Office
Master
Wirtschaft
Deutsch

Vollständige Stellenbeschreibung

Meditrial is a full-service clinical research organization (CRO) dedicated to clinical trial conduct, medical education, regulatory affairs and market access. Our offices are located in Germany, Italy, Switzerland, UK, United States and our teams rely on digital tools to work collaboratively to achieve shared goals.

Since 2008, Meditrial delivers unparalleled outcomes for innovators. Our successful track record supporting the lifescience industry manufacturers in all phases of clinical development puts us in a prime position to seize the opportunity to emerge as a leader in digital technology with the promise that it will enhance and alleviate the clinical trial and participant burden. Through our work, the patient and innovator are empowered with data and insights across the lifecycle of product development and market penetration changing the paradigm of care towards understanding and value. We have the ability to transcend the current landscape with “smart” technology enabled data collection tools and insights.

Meditrial offers highest level expertise across multiple therapeutic areas. We are passionate about our mission to support the innovation and development of better therapies in compliance with solid ethical standards. Our commitment has resulted in excellent results for business growth by creating stability and opportunities for employees and collaborators.

Regulatory Affairs Manager - Pharma/Medical Device:
Industry: Lifescience Industry: Pharma, Medtech, Digital Health

Employment Type: Full-time

Job Functions: Regulatory Affairs

Location: Meditrial GmbH, Berlin, Germany

Workplace: Office-based / availability to travel

The Regulatory Affairs Manager oversees the regulation process for products (Medical Device and Marketing Authorization) requiring governmental approval, including filing necessary applications and handling all government interactions. The Position will ultimately support and/or drive strategic regulatory strategies for multiple projects together with the subject matter experts. Coordinates inspections of the organization and contract facilities, and develops procedures to ensure regulatory compliance pre and post-market. The position is office-based (Rome)

Responsibilities

Management of a CTD (Electronic Common Technical Document)
Collaborate during implementations of regulatory strategies for New MA through National/Decentralized/Centralized Procedures
Drafting / reviewing high level clinical investigation protocols, IB's, IFUs, clinical study reports, CER, CEP, PMS, SoA, etc.
Preparing the submissions of variations type I, II, Renewals, and Safety variations
Manage the CMC activities (updating module III of ECTD)
Collaborate during the Technical File (TF) creation and any updates
Relationship with manufacturer
Interface with all pharmaceuticals database
Review and submission of promotional materials
Support the management of clinical investigations
Manage the Medical Device Post-marketing and Surveillance Medical Devices activities
Supervise International Regulatory and Quality activities
In addition to the above activities, the role can be asked to carry out tasks related to the belonging function or that may result from business needs

Qualification

Education: Master’s Degree in science or related field, Doctor of Medicine MD is a plus;

Thorough experience in life-science field and Regulatory Affairs;

Languages: proficiency in oral and written English and German (third language is a plus);

Proficient in Microsoft Office (MS Outlook, MS Word, MS Excel, Ms Power Point);

Excellent communication, planning and organizational skills;

Demonstrated ability to handle multiple competing priorities.

Preferred: experience in biostatistics

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