Regulatory Affairs Manager

2 dagen geleden

Almere, Flevoland, Nederland Sandoz Nederland Voltijd

Job Description
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 (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 role is majorly focused on RA system, RA intelligence, projects and/or RA operations.

Your Key Responsibilities
Your responsibilities include, but not limited to:

Regulatory Activities

  • 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 and checks 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 the internal country responsibilities in the artwork process as described in the relevant WPs.
  • 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.

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.

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 lead. Leading in terms of Sandoz values and principles

General Sandoz Requirements

  • Adhere to Sandoz values and principles.
  • 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.

Essential Requirements
What you'll bring to the role:
Education

  • Scientific Degree (Pharmaceutical, Biomedical, Life Sciences)

Languages

  • Dutch and English (verbal and written)

Professional Experience

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

Competencies

  • Fluent in Dutch 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

You'll Receive
We offer temporary employment for 1 year with probation period with flexible working, learning and development opportunities. We offer indefinite employment contract based on performance after the first year of employment.

Why Sandoz?
Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported

Join us

Commitment To Diversity & Inclusion
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.

#Sandoz

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