Manager, Regulatory Affairs

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Job Description

OBJECTIVES/PURPOSE:  

Manager Regulatory Affairs ensures obtaining regulatory approval for products and life cycle management of products and regulatory submission with Indian Health Authority (CDSCO) and NMRA Sri Lanka. This role helps Takeda navigate complex regulatory landscapes, ensuring regulatory compliances with respect to the Health Authority and facilitating the successful maintenance of products registration and licenses.

KEY JOBS ACCOUNTABILITIES:

• Managing regulatory approval for products and life cycle management of products of regulatory compliance with Indian Health Authority (CDSCO).
• Manage the regulatory submission of product for regulatory approvals like Marketing Authorization, Registration certificate, Import License, variation submission/Post approval changes and labels updates any submission related to life cycle management of product with Indian Health Authority (CDSCO) and NMRA, Sri-Lanka through distributor.
• Provide regulatory documentation support for tenders and regulatory consultation to support business continuity.
• Represent the company effectively in discussions and consultations with CDSCO and government laboratories (e.g., NIB and IPC) for registration sample testing.
• Manage regulatory activities to obtain required approvals and licenses, including maintenance for the warehouse and redesign activities with the State FDA.
• Manage the regulatory database for regulatory filings and approvals and maintain document archival.

EDUCATION, BEHAVIOURAL COMPETENCIES AND SKILLS:

• Bachelor’s degree in Pharmacy, Life Sciences, Medicine, or related field (advanced degree preferred).
• Minimum 5 years of experience in pharmaceutical industry in Regulatory affairs and preferably in biological products.
• Strong knowledge of Indian regulatory requirements for pharmaceutical product registrations and interpretation.
• Understanding of India business decision-making processes impacting regulatory strategy.
• Strong verbal and written communication.
• Project management; stakeholder management; cross-functional collaboration.
• Customer focus; creative thinking; problem solving.
• Ability to manage effective consultation with India Health Authority CDSCO.
• Track record in managing product registrations/licenses.
• Strong documentation discipline and expertise in RA System and Tool like Veeva

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