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Grifols Shared Services North America, Inc Regulatory Affairs Manager in Clayton, North Carolina

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Summary:

This role is responsible for the assessment, compilation, and submission of regulatory documentation to global Health Agencies in electronic and/or paper formats in compliance with domestic and international regulatory requirements and company timelines. Responsible for assigned projects/submissions focused from a product line manager perspective. Proactively interacts directly with global affiliates and distributors to determine international licensing requirements to support Grifols business objectives and Health Authority requirements are met. Prepare and compile necessary documentation to support submissions including requests for documentation from responsible Grifols subject matter experts (SMEs) to support project timelines and global regulatory requirements. Ensures management of regulatory information for assigned responsibilities utilyzing department business systems and processes.

Primary Responsibilities:

  • Act as Regulatory Affairs authority for specified key products. Perform necessary research and outreach to global affiliates as to understand product history and domestic and international regulatory requirements.

  • Manage and prepare complex submissions to various governmental agencies and ensure contents are in compliance with domestic and international regulatory requirements in accordance with company timelines to meet registration objectives worldwide. Tracks and updates management regarding regulatory deliverables and issues.

  • Compiles registration dossiers/product development applications (e.g., BLA, MAAs, NDSs, NDAs, INDs/CTAs, Orphan Drug Applications etc) and lifecycle management submissions (supplements, variations, amendments) for all regions including management of submissions through all phases of regulatory authority review (e.g., pre-planning, submission, information requests, amendments etc.) to obtain approval.

  • Prepare and/or supervise recurrent and routinely requested data, listing, and notifications for assigned projects for submission to regulatory agencies with other departments, complete applications and forms, compose cover letters and summaries, assemble/format submissions in such a manner to facilitate the review process and ensure statutory timelines are met.

  • Collaborate with cross-functional subject matter experts to compile comprehensive scientific and technical information for use in regulatory submissions.

  • Responsible for data maintenance regarding submissions in the regulatory tracking and filing systems for all regions.

  • Collaborate with cross-functional subject matter experts to identify documentation to support responses to regulatory agency inquiries.

  • Act as a technical advisor on regulatory requirements for assigned projects and task forces for specific products.

  • Initiates action to ensure appropriate internal policies and procedures are developed to comply with new or modified regulations.

  • 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. Identify unique country specific document/data requirements and communicate to appropriate cross-functional subject matter experts as needed to support project timelines.

  • Perform additional duties as required.

Knowledge, Skills, & Abilities:

  • Ability to prioritize and manage multiple and possibly conflicting priorities.

  • Ability to work independently and initiate and manage contacts essential to submission preparation.

  • Ability to work as part of the regulatory team to meet group objectives and to lead and motivate.

  • Ability to work with management of other Grifols departments in order to achieve the common business as well as regulatory objectives.

  • Ability to review a document in detail to ensure accuracy based on regulatory requirements, and to ensure the use of the appropriate forms, format, content, and authorized signatures.

  • Ability to summarize and effectively present complex information verbally and in writing to internal and external audiences, including regulatory authorities at the federal, state, and local levels.

  • Ability to effectively use Microsoft Office (particularly Word and Excel) to create, edit, and format documents

  • Ability to work with other computer systems for filing supplements and reports.

  • Ability to interpret and effectively communicate regulatory requirements.

  • Ability to successfully interact with regulatory agencies through professional, articulate, and courteous conversations and clear, concise written communications.

  • Ability to meet statutory deadlines to ensure compliance, as well as business timelines to accomplish company objectives.

Requirements:

  • Bachelor’s degree in relevant discipline, or equivalent work 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

EEO minorities/Females/Disability/Veterans

Req ID: 257907

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