Country Regulatory Affairs Manager (d/f/m) - 60%

Sandoz continues to go through an exciting and transformative period as a global leader and pioneering provider of sustainable Biosimilar and Generic medicines. As we continue down this new and ambitious path, unique opportunities will present themselves, both professionally and personally. Join us, the future is ours to shape! 

The Country Regulatory Affairs Manager is responsible for selective Regulatory Affairs (RA) activities within the country RA department to support obtaining and maintaining marketing authorizations and ensure regulatory compliance at country level. 

The RA activities can be focused on RA operations, projects, and/or RA system and RA intelligence. 

Major accountabilities:  

Responsibilities include but not limited to: 

Team and culture  

• Coach and train new employees or interns.  

• Soft people management in case of internships, mentoring, temporary assignments within the team.  

• Back-up for Country RA Head for specific tasks (as per country needs and defined by Country RA Head).

• Be seen as an RA expert, and experienced project leader. Leading in terms of V&B’s.

Compliance

• Ensures Regulatory Compliance and Governance.

• Guarantees compliance with overall standards required for regulatory submissions and ensures adherence to Sandoz standards, and local health authority legislation and expectations. 

• Guarantees correct implementation and adherence to the relevant (local) procedures, and record management.  

• Supports and as SME represents RA during internal and external audits and health authority inspections at country level. 

Activities to support Sandoz and our customers 

• Supports the roll-out of the RA department strategy in country and aligns with Regional and Global regulatory strategy (where relevant).

• Guarantees timely creation & translation of official product information including:  

• Patient Information Leaflets, Summary of Product Characteristics (SmPCs) and all labelling (packaging texts into artworks)).

• Guarantees timely implementation of changes of the registered text into artworks. This can be either by overseeing or by performing the process tasks below as per country specific set-up:

• Perform text and Design review (manual proofreading and/or with support of electronical tools) and related documentation of created artworks according to GxP requirements. 

• Ensure that all artworks are created as per the country specific requirements and the Sandoz brand expectations and implemented within the legal or internal timeframe.

• Perform the internal country responsibilities in the artwork process as described in the relevant SOPs.  

• Maintenance of registration files. This is done by (non-limitative list):  

• Registration maintenance activities, product related text translations (checks)

• Answering questions from local health authorities regarding registered products.

• Artwork management from change to approved new/revised artwork.

• Updating regulatory databases and plans.

• Local regulatory tasks related to Risk Management Plan (RMP) / Risk Minimization Activities (RMA) and Dear Healthcare Professional Communications (DHPC) (as per global SOP).

• Strives to achieve earliest acceptance of registration applications, launches and product site transfers.

• Provides regulatory support (general and product-specific) to the internal organization (e.g. Business Units, Portfolio & Launch, Medical).

• Plays an active role in the local launch team to achieve the company’s business objectives.

• Strives for efficient and simplified ways of working and does this by identifying and implementing process improvement initiatives. Drive process optimization for activities under responsibilities.

• For the activities in scope of the role ensures that all relevant Key Performance Indicators (including safety label changes, artwork, checklists, deviations, RA input in RMP implementation and DHPC communication), are achieved timely & correctly and that all GxP and RA relevant documents are archived as per specifications.

• Guarantee good and professional communication between internal and external stakeholders.

• Be the in-country SME on RA processes, tools and/or projects in scope of the role.

• Assessment and rollout of global policies and new or changed legislation. Write and implement (local) SOPs for RA processes, as applicable.

• Perform (or support) and document root cause investigations in case of deviations from the process and the development and execution of corrective and preventive measures.

• Perform and interpret KPI and compliance tracking of the operational activities. 

• Lead (local) RA projects. 

Minimum Requirements:  

What you’ll bring to the role: 

• Bachelor’s degree in / Pharmaceutical sciences, preferable Master in Bio-Medical / Life Sciences / Pharmaceutical sciences. 

• 3+ years of relevant experience as an RA Manager, with extensive exposure to the pharmaceutical industry within a highly regulated environment. 

• Solid understanding and hands-on experience in risk management, process optimization, and SOP development and writing. 

• Fluent German and English, both written and spoken. French is desirable, and Italian is considered an asset. 

• Strong stakeholder management, communication, and organizational skills, with the ability to deliver results in complex, regulated environments while upholding high ethical and compliance standards.