Rcc-sir Group Lead

vor 2 Wochen

Munich, Bayern, Deutschland Sandoz International Vollzeit

Sandoz is going through an exciting and transformative period as a global leader and pioneering provider of sustainable Generic and Biosimilar medicines.

Join us as a Founder of our 'new' Sandoz

Job Summary/Purpose:


Group Lead for the Regulatory Competence Centre (RCC) - Sandoz International Region (SIR) Global team is tasked with coordinating regulatory submissions for new products in SIR markets (LATAM and APMA), excluding Japan.

The main task of the RCC-SIR Group Lead is to manage the RCC-SIR Global team associates, to ensure:

  • The team acts as a strategic partner with respective Country Regulatory organizations to develop robust and creative regional and local submission strategies for implementation of agreed and aligned submission plans
  • Collation, evaluation and dissemination of SIR market regulatory intelligence, country requirements, policy, and compliance information to relevant stakeholders and partners.
  • Coordination, preparation, and submission of highquality regulatory dossiers in SIR markets and ensuring the timely submission of responses to deficiency letters.

Your key responsibilities:

Strategic RCC and registration policy:

  • Encourages and drives close collaborate with Country Regulatory colleagues to ensure regionspecific regulatory strategies are aligned with overarching Sandoz Global Development strategies and Commercial priorities and are implemented according to plan.
  • Employs robust tactical actions to ensure timely registrations, approvals, and regulatory support for product launches and their subsequent maintenance in SIR countries.
  • Identifies regulatory risks, issues and mitigation actions associated with SIR submission strategies and communicates to relevant stakeholders.
  • Ensures regulatory documents, for example to support a new product submission, are made available to SIR Country Regulatory colleagues as quickly as possible.
  • Engages with Country Regulatory colleagues to evaluate the impact of new or updated legislation or requirements in SIR countries on existing and planned marketing authorisations.

Organized RCC:

  • Identifies and implements process and efficiency improvement initiatives within the RCC-SIR Global team.
  • Shares thoughts, knowledge, and feedback on ways of working with colleagues across RCC SIR and, where appropriate, across the wider Sandoz organisation.
  • Sets and monitors appropriate indicators to measure performance of the RCC-SIR Global team against business and organisational objectives.
  • Ensures RCC-SIR Global team associates are adequately trained in accordance with allocated SRA curricula and are maintaining knowledge and skills commensurate with their roles.
  • Encourages and supporting professional and personal development and growth within the RCC-SIR Global team, e.g., by establishing development plans for individuals and identifying aligned opportunities
  • Effectively allocates projects, tasks and activities to ensure success, whilst also considering opportunities to provide learning and growth
  • Creates/maintains a work environment which stimulates and motivates people.
  • Supports internal and external initiatives and projects that serve to further the interests and success of patients, Sandoz, or the wider generic pharmaceutical industry.
  • Ensures collation of current and anticipated SIR country regulatory information, intelligence, and trends, and evaluates potential impact to business or project decisions and direction, with timely crossfunctional communication as necessary.
Diversity and Inclusion

  • We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve._
Minimum Requirements

What you'll bring to the role:

  • Degree in Science (e.g., Chemistry, Pharmacy, Biochemistry, Biology) or equivalent.
  • Fluent English
  • Lifescience studies and expert knowledge of regulatory affairs processes.
  • Experienced global regulatory leader with at least 10 years regulatory experience, ideally in the generic field.
  • Prior experience of managing a team.
  • Strong knowledge and interest in the evolving regulatory landscape of ICH and nonICH countries.
  • Leadership skills: setting clear direction, aligning teams, motivating and developing direct reports to inspire proactivity and innovation.
  • Comprehensive RA understanding, excellent knowledge of relevant regulatory guidelines and very good understanding of authority expectations in SIR markets.
  • Good understanding of Manufacturing and QA fundamentals.
  • Good understanding of generic market structures.
  • Solid knowhow of project management techniques. Knowhow in quality assurance and pharmaceutical technology.
  • Proven track record in organisational transformation and change management

Desirable Requirements:

  • Advanced Degree in Science.
  • Good skills in local language of site desired (oral) are an advantage.
  • Experience from other pharma areas is a plus.
  • Proven tra

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