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Grifols · 1 month ago

Sr. Regulatory Affairs Specialist II/Manager

North Carolina, United States

Full-time

Onsite

Senior Level

5+ years exp

Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. The Sr. Regulatory Affairs Specialist II/Manager will implement worldwide regulatory product registration strategies and coordinate regulatory documentation for market authorization.

BiotechnologyHealth CareManufacturing

Responsibilities

Act as Regulatory Affairs authority for key product registrations with a main focus in labeling and labeling related activities

Analyze and determine worldwide product registration requirements for specific assigned products and regions. Implement worldwide regulatory registration strategy, communicate and negotiate with local market authorization holders/ distributors / regulatory authorities the information required and prepare regulatory submissions to be used worldwide for all marketed products

Prepare complex registration dossiers, local application forms; negotiate documentation required for worldwide markets which may include product custom clearance documentation and coordinate with International Customer Service, Quality and Commercial preparation of required documentation in accordance with local requirements

Prepare responses to regulatory agency inquiries

Coordinate with local authorities and Quality standards and controls required for product registration testing

Represent the regulatory function in communication with outside companies, customers and regulatory authorities. Responsibilities may include preparation and presentation (if required) to regulatory authorities. (e.g. labeling specific projects)

Represent the regulatory function on project teams as related to worldwide product registrations. Provide information that is presented to, for example, the Peer Review Committee, the Site Leadership Team and the Quality Management Review to enable informed decisions

Collaborate with all disciplines to assure appropriate testing and documentation are generated for regulatory submissions and routine import documentation. Prepare personnel from affiliates or third parties for meetings with regulatory authorities

Coordinate and interact with domestic and international regulatory counterparts to obtain input regarding regulatory considerations and decisions to formulate regulatory strategy for changes to products/facilities/equipment with an impact on product labeling

Request and obtain all required FDA export documentation required for registration and routine product shipments

Evaluate impact of new labeling regulatory requirements as well as evaluate changes to existing product labeling on assigned projects and products and inform other departments as necessary

Maintain worldwide product registration status and distribute routine updates to commercial, sales and Quality to determine where registered products can be marketed

Mentor and support the professional development of staff

Perform other duties as required

Qualification

Regulatory AffairsLabeling RequirementsProduct RegistrationBiological ProductsRegulatory SubmissionsMicrosoft OfficeDocument ReviewCommunication SkillsTeam Collaboration

Required

Bachelor's degree in relevant discipline, or equivalent work experience industry regulatory experience

Minimum 5 years of related technical and/or regulatory experience in pharmaceutical industry or an equivalent combination of education and experience

Experience with biological products related to but not limited to facilities, validation, environmental monitoring, cGMP manufacturing, QA/QC for biological products, compliance and/or regulatory is required

Excellent written and verbal communication skills

Knowledge of applicable laws and regulations

Bachelor's degree in relevant discipline, or equivalent work experience industry regulatory experience

6 to 7 years related technical and/or regulatory experience in pharmaceutical industry, or an equivalent combination of education and experience

Extensive knowledge of applicable worldwide regulatory product registrations laws and regulations

Excellent verbal and written communication skills