Specialist Regulatory Affairs (Remote)

Specialist Regulatory Affairs

THE ROLE

The position is for a Specialist in Regulatory Affairs ,with primary responsibility for supporting the regulatory compliance of product labels and packaging across global markets.

The role is responsible for assessing the correctness, completeness and consistency of product labelling against applicable national and international regulatory requirements and internal standards. This includes review of product information, ingredient declarations, mandatory statements, warnings, and other regulated label elements.

The Specialist will work closely with Regulatory Affairs, R&D, Marketing, Packaging, Artwork and other relevant functions to support the development and commercialization of compliant products, ensuring regulatory requirements are appropriately translated into product labels and artwork.

The role also supports the resolution of label-related regulatory issues, maintenance and continuous improvement of global labelling processes, systems and procedures, and implementation of regulatory changes impacting existing or new products.

KEY RESPONSIBILITIES

The position includes the following responsibilities:

• Review and assess product labels and artwork to ensure compliance with applicable regulatory requirements and internal standards before commercialization.

• Verify the correctness and completeness of mandatory label information, including ingredient declarations, warnings and precautions, product function, instructions for use, responsible person/manufacturer information, nominal content and other regulated labelling elements, as applicable.

• Ensure consistency between product formulation, regulatory documentation and information appearing on pack, identifying and resolving discrepancies prior to product launch.

• Translate applicable regulatory requirements into clear labelling requirements and guidance for internal stakeholders involved in artwork and packaging development.

• Provide regulatory input during the artwork development and approval process, working cross-functionally with R&D, Marketing, Packaging, Artwork and other relevant teams to enable timely commercialization.

• Identify and manage label compliance issues, providing pragmatic regulatory solutions while maintaining compliance and protecting consumer safety.

• Monitor regulatory developments impacting product labelling and support the implementation of labelling changes for new and existing products.

• Support local Regulatory teams in addressing label-related questions from authorities, customers or internal stakeholders, including assessment of market-specific requirements where needed.

• Support the development, maintenance and continuous improvement of global labelling standards, procedures, checklists, databases and regulatory systems.

• Maintain appropriate documentation and traceability of regulatory label assessments and approvals.

• Contribute to cross-functional and global regulatory projects related to labelling, artwork compliance, regulatory data and process improvement

QUALIFICATIONS

• Bachelor’s degree in a scientific discipline or equivalent experience in a relevant role or industry sector, such as Regulatory Affairs, Quality Assurance, Product Compliance or related technical functions within the Cosmetics, Pharmaceutical, Medical Device or Food industries.

• Sufficient knowledge of chemistry and/or biology to understand and interpret technical legislation, product and ingredient documentation, test reports and scientific information relevant to cosmetic products and their labelling.

• 1–2 years of experience in Regulatory Affairs, Label Compliance, Quality Assurance, Product Compliance or another technical role within the cosmetics, pharmaceutical, medical device or food industry would be an advantage.

• Interest in and ability to interpret regulatory requirements and translate them into clear, practical labelling requirements.

• Strong attention to detail and accuracy, with the ability to identify inconsistencies or gaps in labels, artwork, ingredient information and supporting product documentation.

• Strong written communication skills, particularly when working with detailed, technical and regulatory information.

• Very good command of English, both written and spoken. Good command of German is an advantage/requirement, depending on the needs of the position.

• High degree of commitment and strong motivation to develop a career in Regulatory Affairs.

• Proficiency in Microsoft Office and a high level of general digital literacy, with the ability to quickly learn and work with new regulatory, artwork and data-management systems.

• Good analytical and problem-solving skills, with the ability to assess regulatory information, identify compliance risks and contribute to pragmatic solutions.

• Excellent organizational skills, with the ability to manage detailed reviews and assignments accurately and maintain appropriate documentation and traceability.

• Ability to work effectively both independently and as part of cross-functional and international teams, collaborating with Regulatory Affairs, R&D, Marketing, Packaging, Artwork and other relevant functions.

• Ability to manage multiple priorities and meet deadlines in a fast-paced environment, while adapting effectively to changing business priorities.

• Proactive, accountable and solution-oriented mindset, with the confidence to raise potential compliance concerns and follow them through to resolution.