Manager/Sr. Manager, Regulatory Affairs – Labeling

Grifols

Regulatory Affairs Manager coordinating global product registration and documentation in healthcare industry. Ensuring compliance with regulatory requirements and managing labeling processes globally.

Posted 6/5/2026full-timeClayton • North Carolina • 🇺🇸 United StatesSeniorWebsite

About the role

Key responsibilities & impact

Implement worldwide regulatory product registration strategies, prepare complex registration dossiers, establish and maintain tracking of product registrations to determine what products can be shipped to intended markets in accordance with business plan with a specific focus on labeling, labeling requirements, and implementation.
Coordinate and submit all regulatory documentation for establishment of new / changed local market authorization holders and distributors.
Analyze and determine worldwide product registration requirements for specific assigned products and regions.
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 responses to regulatory agency inquiries.
Coordinate with local authorities and Quality standards and controls required for product registration testing.
Prepare personnel from affiliates or third parties for meetings with regulatory authorities.

Requirements

What you’ll need

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.
Ability to prioritize and initiate contacts essential to labeling submission preparation.
Ability to work independently and initiate contacts essential to create labeling components for submission preparation and ensure technical information is accurate.
Knowledge of product and labeling history to maintain consistency within a product line and within the product portfolio labeling.
Ability to clearly communicate verbally and in writing with internal and external contacts that may include industry representatives, affiliates, third parties and regulatory authorities in various countries.
Ability to work with management of other Grifols departments to achieve common business goals as well as regulatory objectives.
Ability to review a document, including labeling, in detail to ensure accuracy based on regulatory requirements, and to ensure the use of the appropriate forms, format, content, and authorized signatures.

Benefits

Comp & perks

Health insurance
401(k) matching
Paid time off

ATS Keywords

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Applicant Tracking System Keywords

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Hard Skills & Tools

regulatory product registrationregistration dossiersregulatory documentationproduct registration requirementsregulatory submissionslabeling requirementsquality standardsregulatory agency inquirieslabeling componentsdocument review

Soft Skills

communicationnegotiationindependenceprioritizationattention to detailcollaborationinitiativeaccuracyorganizational skillsinterpersonal skills

Certifications

Bachelor’s degree