Regulatory Affairs Manager, EMA
Becton Dickinson and Company
Total des années d'expérience :16 years, 0 Mois
• Formulate and implement EMA regulatory strategies and plans to ensure that Infusion Systems products (including infusion pumps, dedicated sets & software) are developed in accordance with global and national regulatory requirements.
• Analyze risk versus benefit in regulatory strategies to ensure successful review by different EMA regulatory authorities.
• Lead, support and collaborate discussions within cross-functional teams by communicating regulatory plans, requirements, and timelines.
• Empower and coach my team by setting clear direction, rational expectation and remove barriers.
• Enable and assign regulatory activities to my team ensuring compliance with regulations and standard operating procedures.
• Drive continual growth through comprehensive knowledge and operational expertise globally (Planning for RAC Device Exam this fall).
• Oversee creation and maintenance of agreements between importers and distributors.
• Validate all marketing materials/Ad Proms ensuring their compliance to the local regulations.
• Develop, maintain, and get the Medication Management Solutions platform regulatory planning executed.
• Maintain the current registrations (renewals and change management), geographic expansion and new product launches,
• Assess impact of new regulation or changes in regulations locally in the countries or in Europe.
• Coordinating the registration plan across the countries RA, BU RA and EMA business contacts.
• Streaming registrations of the products as needed as per prioritization list.
• Providing regulatory support and coordination for PMS of MMS platform in EMA.
• Conduct compliance review on technical documentation to assure compliance with EMA regulatory requirements and standards.
• Working closely with the local regulatory affairs counterparts to capture the existing and upcoming regulatory expectations and take appropriate actions.
• Anticipating regulatory impacts and emerging issues for the continued supply of the devices and support their resolutions as part of cross functional teams.
• Maintaining a list of current registration and communicate potential gaps.
• Addressing related inquiries initiated by MMS sales organizations, product managers or RA colleagues with accurate data for external use.
• Implement registration strategies to secure market authorisations and product launch in the Middle East region.
• Communicate countries’ jurisdictions and regulations and report changes to the business and stating clearly its anticipated business impact.
• Prepare regulatory dossiers for submission to Health Authorities across the region.
• Develop a relationship with relevant regulators to support positive compliance; co-ordinate queries and responses to domestic and foreign regulators.
• Maintain a dynamic database for regulations and registration requirements.
• Maintenance of existing product licenses.
• Monitor regulation changes to ensure continued compliance.
• Support audits performed by MOHAP representatives.
• Notify Health authorities with the corresponding Field Safety Corrective Actions; ensure compliance to the regulations
• Co-ordinated with International RA, prepare and submit of the regulatory approval documents required for registration that comply with the conformity of the regulatory in UAE.
• Assessed the core dossier as per UAE requirements.
• Prepared and submitted variation, minor changes and renewals.
• Requested the non-technical and legalized documents as required (ISO, FDA, etc, …)
• Updated the registration list and status for all products and inform all departments for any changes.
• Ensured compliance with current regulatory standards for the importation, release, storage and distribution of the company’s products.
• Notified authorities for any product variations or update effecting products sold.
• Archived all regulatory documentation including submission and approvals.
Managing the store and all function related to the pharmacy.
Pharmaceutical Science
