Head Regulatory Affairs – Vaccines

Purpose

The role has overall responsibility for Vaccines portfolio related activities in Regulatory Affairs including interactions with regulatory authorities, government bodies, industry associations and other internal/external stakeholders

Main Accountabilities

• Regulatory ownership with necessary business acumen to support the vaccines business unit (BU) in India, Nepal and Sri Lanka

• Develop and ensure implementation of strategic regulatory pathways for Sanofi products in terms of market authorizations to enable faster to market

• Liaison with internal regulatory team such as Global Regulatory to support business continuity related to submissions/approvals for renewals, post approval changes etc.

• Ensure product packaging and associated information are updated, timely implemented and maintained in accordance with the current product licenses.

• Review and approve promotional and non-promotional materials ensuring their compliance with local regulations, code of conduct and internal guidelines. Co-ordinate review with the responsible functions in the country.

• Actively follow the development and emergence of new regulatory requirements and assess their impact on the existing products and in development.

• Provide regulatory input to product portfolio optimization and product pruning at affiliate level and give regulatory input to global product portfolio optimization strategies

• Ensure local implementation of Global Regulatory Affairs (GRA) mandatory SOPs and training and timely and accurate completion of databases (e.g. VAULT, STARR etc.)

• Represent regulatory in the senior leadership team for the vaccines BU

• Interact with Indian regulatory authorities such as CDSCO, CDTL, CDL etc., and government bodies such as Ministry of Health, Indian Pharmacopeia Commission, NPPA on need basis

• Shape the country Regulatory environment through active contribution in regional industry associations and in collaboration with Public Affairs

• Work efficiently with cross function teams such as supply chain, quality, medical, commercial etc. within the organization to provide timely regulatory guidance to support new product launches and business continuity requirements

• Lead and develop the Regulatory team

Knowledge, Skills & Competencies

• Good knowledge in Indian regulations governing biological products and medical devices

• Ability to plan projects and understand priorities

• People and project management skills

• Verbal and written negotiation and interpersonal communication skills

• Ability to work in multicultural environment

• Communicate effectively and efficiently with other functional departments

• Ability to foresee and respond to potential problems and opportunities and prioritize the regulatory activities

Qualifications

Education: M Pharm, MSc, Pharm D or equivalent preferred with at least 12 years of regulatory experience in a Pharmaceutical Company.

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