RCC-SIR Group Lead (d/f/m)

☞ Sandoz International

看过: 118

更新日: 06-10-2024

位置: Munich Bavaria

类别: 制药/化学/生物技术

行业:

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工作内容

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.
  • Carries out the organization policy for personnel affairs and applying the available P&O instruments in an adequate way
  • 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 track record of creativity, problem solving and productivity.
  • Excellent skills in presentation, scientific / technical writing, advanced communication ,and negotiation.
  • Demonstrated successful experience working in interdisciplinary teams in a complex matrix environment and dealing with continuous change and occasionally conflicting priorities.

Why Sandoz?

Almost 500 million patients were touched by Sandoz generic and biosimilar medicines in 2022 and while we’re proud of this, we know there is more we could do to continue to help pioneer access to medicines for people around the world.




We are at a pivotal moment in our history giving us the freedom to invest in our future so we can continue to help millions of people access affordable high-quality medicines. Together we will shape the future of Sandoz, building an organization from the ground up and in return, experience an ambitious environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is encouraged!




The future is ours to shape!

Join our Sandoz Network: If this role is not suitable to your experience or career goals but you wish to stay connected to learn more about Sandoz and our career opportunities, join the Sandoz Network here: https://talentnetwork.novartis.com/sandoztalentpool



#Sandoz
Division
SANDOZ
Business Unit
Sandoz Global Development
Location
Germany
Site
Holzkirchen (near Munich)
Company/Legal Entity
Sandoz International
Functional Area
Research & Development
Job Type
Full Time
Employment Type
Regular
Shift Work
No
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最后期限: 20-11-2024

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