Regulatory Affairs Manager

4 mesi fa

Lazio, Italia Meditrial Europe Ltd. A tempo pieno

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, the UK, and the 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 the highest level of 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, Via Po 9 Rome, Italy

Workplace: Office-based / availability to travel

The Regulatory Affairs Manager (Pharma) 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
Preparing the submissions of variations type I, II, Renewals, and Safety variations
Manage the CMC activities (updating module III of ECTD)
Collaborate during the Management of Recall
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
Notify the new Food Supplements and any changes to Ministry of Health
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 Italian (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.

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