Job Description

The Country Regulatory Affairs Manager (cRAM) 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 – depending on the specific functional needs in country – be focused on RA operations, projects and/or RA system and RA intelligence.

Major Activities

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 Associate Director for specific tasks
• Be seen as an RA expert, and experienced project lead.
• Leading in terms of V&B’s

Compliance:

• Ensures Regulatory Compliance and Governance
• Guarantees compliance to 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.

• Can represent country RA during internal and external audits and Health Authorities inspections at country level for its scope and activities.

Activities to support Sandoz and our customers

• Supports the roll-out of the RA department strategy in country
• 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.
• 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) SOP’s 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.

General Sandoz requirements:

• Adhere to Sandoz values and behaviors policies.

• Adhere to Sandoz's anti-bribery, confidentiality, and ethical standards and policies.

• Adhere to relevant GxP and pharmacovigilance requirements as established in the processes and tools.

Key Performance Indicators

• Timely receipt of new Marketing Authorizations

• Proper maintenance of Marketing Authorizations

• Quality of relationship with local health authorities

• Timely execution of projects

• Stick to defined KPI’s

Ideal Background

Education

• University Degree, preferable Master in Bio-Medical / Life Sciences / Pharmaceutical sciences.
• Min 3-year relevant work experience

Languages:

• National language(s) and English (verbal and written)

Professional Experience:

• Extensive experience in the pharmaceutical industry (> 3 y)
• Working in a highly regulated environment.
• Understanding and experience of risk management
• Understanding and experience with process optimization and SOP writing.

Competencies:

• Fluent in national language(s) and English
• Stakeholder management
• Planning, organizational skills and eye for detail
• Strong written communication skills
• Data management and IT skills (MS Office package / SAP)
• Accountability for actions, setting own priorities and decision taking
• Result oriented.
• High ethical standards

Skills Desired

Data Analysis, Documentation Management, Lifesciences, Regulatory Compliance, Waterfall Project Management