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Rcc-sir Group Lead
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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 high-quality 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 region-specific regulatory strategies are aligned with over-arching 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 cross-functional 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
- Life-science 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 non-ICH countries.
- Leadership skills: setting clear direction, aligning teams, motivating and developing direct reports to inspire pro-activity 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
