Quality/Risk Management, Regulatory Compliance, Submission & Registration, US Regulatory Affairs
4 Year Degree
The Senior Regulatory Affairs Officer acts as an US Agent supporting regulatory activities by providing regulatory guidance and submitting the corresponding documents to FDA. Good communication and interpersonal skills will be imperative in the interactions with customers, coworkers and our headquarters in France. Macopharma is a dynamic company in a dynamic market, which means that the ability to quickly adapt to new situations and work assignments is required.
Develops appropriate regulatory strategy for bringing Macopharma products to the US which can include both Transfusion and Biotherapy products (Medical Devices and Drugs).
Identifies the status of the product according to the country (Medical Device, medicine )
Considers and offers different recording strategies and their advantages / disadvantages to the AR Manager
Sets optimally the elements necessary for the compilation of files (studies, supplier documents and validations) according to the regulations and regulatory guidelines
Collects data to assess compliance with the expectations of the authorities (content and form).
Edits and submits the registration file to the competent authorities or notified bodies
Develop good relationships with the authorities (lobbying folder)
Responds to questions raised during the evaluation by the competent authorities or notified bodies
Keeps abreast of regulatory changes (pharmaceutical legislation Pharmacopoeias, guidelines) Analysis and determines whether these changes have an impact on our business
Exchange with the service Materio/Pharmaco/ Biovigilance as part of risk management plans, the submission of periodic reports vigilance and change requests for medical information
Education and Experience with FDA submissions/registrations for medical devices and drugs 4 years degree required in scientific field
Ability to multi-task effectively and juggle competing priorities and complete projects under tight deadlines
Expertise with Microsoft Package (Word, Excel, Powerpoint)
Excellent organization and follow-up skills
High level accuracy and attention to detail
High level of discretion and confidentiality
Ability to communicate in a clear and articulate manner
Telecommuting is allowed.
Internal Number: MACO001
About Macopharma USA
Macopharma is a worldwide, leading and innovative Health Care Company specialising in the fields of Transfusion Medicine and Biotherapy. For more than 40 years, Macopharma has achieved continuous growth and success in these fields. In all our activities, we focus on the improvement of human health outcomes.