Job Description

OBJECTIVE OF THE FUNCTION:

Be the leader of the Shared Service Center in Gurgaon (India) to be set-up for Fresenius Kabi, providing the necessary Regulatory Affairs services to the different Business Units (BUs) and Market Units (MUs) across different geographies and time zones

- Build from the ground-up an organization (100+ employees) which delivers world class Regulatory Affairs services by creating a culture of innovation, excellence and high performance

- Provide strategic and operational leadership to the different delivery teams in the Shared Service Center in alignment with the different BUs and MUs

- Establish solid relationships with the BUs and MUs\' RA functional leaders by leading the collaborative development of service level agreements, adhering to those agreements and monitoring costs, quality, and timeliness

MAIN TASKS:

- Build the Regulatory Affairs (RA) Shared Service Center team from the ground up (100+ staff) structured into different delivery teams, aligned with corresponding BUs and MUs

- Ensure smooth transition of RA activities from existing locations to the SSC

- Align with key stakeholders on service requirements to be delivered

- Continuously train and develop team members for effectiveness and career growth

- Monitor, analyze and report on key data through the development of appropriate metrics which measure the performance of the SSC and resources reporting under it

- Communicate business value, project statistics and issues to business leadership and business sponsors

- Provide unparalleled customer service while ensuring stakeholder confidence and trust with executives in the organization

- Effectively plan and proactively mitigate risks to improve operations through process improvement/redesign and utilizing technology to help reduce workload demands in alignment with the GPO

- Ensure the SSC implements/delivers its commitments and services as per annual operating/financial plan and budgets

- Ensure full compliance with local, regional and corporate compliance rules, regulations and policies

- Consult and partner with all BU and MU leaders in a matrix operating environment to ensure the Gurgaon RA SSC is recognized as a trusted resource for delivering RA services

- Establish and ensure all Service Level Agreements (SLAs) within the RA SSC are consistently met, reviewed, revised as appropriate

- Ensure that the delivery teams are up to date with the necessary Health Agency requirements

- Act as go-to-person for conflict resolution across delivery teams

- Ensure escalation of systematic issues and performance gaps within the process

SECONDARY TASKS:

- Any additional responsibility as deemed necessary

BUSINESS CONTACTS:

- INTERNAL Regulatory Affairs within BUs and MUs, Global Process Owner (GPO), Global Business Services (GBS)

- EXTERN Possibly external service providers

DOTTED LINE REPORTS:

- RA functional leads in Business Units and Market Units across the Fresenius Kabi organization

- Global Business Services\' leader (GBS) located in Pune related to payroll, accounting, finance, etc. support for the RA SSC organization

- Close collaboration with Global Process Owner (GPO) to implement agreed upon improvement initiatives

QUALIFICATION AND WORK EXPERIENCE:

- Master\'s degree in Life Sciences or related field

- 15+ years of total work experience

- Strong background in people management and service delivery

- Previous leadership experience in a Shared Services Center or similar customer-facing type of environments

- Deep understanding of offshore, and shared service organizations and models

- Demonstrated ability in setting strategy, driving performance, consistently producing superior results, cultivating ownership while enforcing company policies

- Fluent in English (written and spoken)

- Knowledge of Regulatory Affairs in Europe, North America, Asia, and/or South America Region preferred

REQUIREMENTS / KNOWLEDGE TO FULFIL THE POSITION:

- Strategic leader with an aptitude for identifying and developing talent and building strong delivery teams

- Ability to deliver within deadlines and strength in facilitating change on a broad scale

- International experience: Self-awareness of communication styles and cultural differences

- Self-motivated and capable of operating independently with limited oversight. Strong sense of personal accountability for work tasks

- Functional knowledge of Regulatory Affairs across Pharma, Nutrition, and Biosimilars

- Strong communication skills across all levels and across geographies

- Excellent organizational skills

- Ability to prioritize tasks efficiently and effectively

- \'Can do\' attitude with a practical approach to problem solving

- High level of commitment

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