Regulatory Affairs & Compliance Manager Nordics

Regulatory Affairs & Compliance Manager Nordics

Galderma

Uppsala, Sweden

For Regulatory Affairs, you will guide regulatory strategy to provide direction for planning and coordinating activities related to product regulatory (biologicals, chemical drugs and medical devices), drugs CMC regulatory, regulatory operations and scientific & medical writing on both new and in-line products, in accordance with health authorities.

For Compliance you will be accountable for compliance strategy, its programs and policies related to the standards established by the business to comply with applicable external legislation/regulations.

Key Tasks

• Oversee the effectiveness of the compliance program and foster a culture of integrity and ethical business practices;
• Ensure compliance with global standards as well as local laws and regulations, guiding implementation of standards and compliance initiatives;
• Support review, approval and documentation for local HCP/HCO compliance and cross-border activities following relevant policies and procedures, including management of disclosure obligations;
• Direct regulatory strategy development and execution, ensuring regulatory advice and input is proactively provided to local business strategies;
• Coordinate and manage registration priorities, strategies, and preparation of dossiers for new and old products. Support global new product & life cycle management-projects, working with other stakeholders;
• Ensure high quality and timely submissions, coordinating with distributors or third parties where applicable;
• Prepare and submit regulatory affairs applications such as new product registrations to meet country’s business objectives and timelines;
• Perform regulatory maintenance of registered products or ingredients to ensure products remain compliant with all relevant government, industry, and corporate requirements throughout their marketed life;
• Review proposed product labels for regulatory assessment and submit to register label changes to the relevant health authority;
• Co-ordinate artwork amendments and tracking of packaging modifications.

Skills & Qualifications

• Pharmacist Degree/Bachelor’s degree in pharmaceutical science;
• Experience in Regulatory Affairs & (HCP) Compliance in the field of medicinal products & medical devices. Cosmetics a plus;
• In-depth knowledge of the pharmaceutical industry across the Nordics country cluster (Sweden, Denmark, Finland, Norway, Iceland);
• Ability to manage senior stake holders;
• Has worked with cross functional matrix project teams;
• Mandatory IMA training (for information & marketing managers) by LIF (Trade Association of the Pharma industry in Sweden).

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