Head of Regulatory Affairs

hace 4 días

Santiago de Chile Sandoz A tiempo completo

**Major Activities**

Team and culture
- Leads, develops and manages the RA department
- Selects, recruits and retains high calibre staff
- Sets objectives, reviews progress, manages and coaches direct line reports

Compliance:

- Ensures Regulatory Compliance and Governance
- Defines overall standards required for regulatory submissions and ensures adherence to Sandoz standards, and local health authority legislation and expectations.
- Oversees implementation of the relevant (local) procedures, and record management.
- Evaluates impact and anticipate future trends, implications of important emerging guidelines and changes in political environment, which are likely to affect Sandoz’ interest.
- Represent RA during internal and external audits and health authority inspections at country level.

**Activities to support Sandoz and our customers**
- Leads the RA department strategy in country and aligns with Regional and Global regulatory strategy (where relevant)
- Accountable for creation & translation of official product information including Patient Information Leaflets, Summary of Product Characteristics (SmPCs) and all labelling (packaging texts into artworks)
- Accountable for timely implementation of changes of the registered text into artworks
- Provides regulatory support (general and product-specific) to the internal organization (e.g. Business Units and Portfolio & Launch, Medical)
- Leads, develops and maintains good relations with Sandoz Global Regulatory and other Sandoz RA country organizations
- Leads working interface with key internal and external stakeholders. Represent Sandoz at trade organizations and at health authorities regarding (changes in) regulatory affairs legislation.
- Leads, manages and undertakes regulatory across the Medical/Marketing/Market Access/QA/PS interface
- Plays an active role in the local launch team to achieve the company’s business objectives
- Acts as Sponsor and Contributor to relevant local and global business initiatives to ensure DRA is seen as a “Best in Class” organization. Drive process optimization for operational excellence and set priorities for the team.
- Ensures Regulatory Compliance for all registered products, in close cooperation with the QA department
- 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

**General Sandoz requirements**
- Adhere to Sandoz values and behaviours 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.

**Country specific additional activities**

Robust and efficient management of distribution partners to ensure timely registration and launch of new products, and regulatory compliance of marketed products.

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