Manager Regulatory Affairs

Regulatory Compliance : Successfully implement regulatory strategy to meet overall business objectives.

Leadership in Assigned Projects : Lead regulatory compliance in assigned projects, effectively managing key stakeholders to drive compliance.

Continuous Learning : Demonstrate agility in learning and acquiring new skills to adapt to evolving regulatory landscapes.

Regulatory Strategy: Develop and implement regulatory strategies that enable the delivery of product innovations and growth of base business to meet overall business objectives.

Product Registration: Develop registration strategies and lead the registration process for all OTC/non-OTC products in India (locally manufactured and/or imported), including Rx and OTC allopathic medicine, Ayurvedic medicines, cosmetics, FSSAI products.

Regulatory Operations : Manage assigned projects e nsuring regulatory compliance of registered products, promotional material and related commercial initiatives .

Regulatory Submissions: Independently manage in a timely manner all license applications, renewals, product registration and variation.

Document Review: Change Control Management, Artworks, Specifications, Dossier readiness.

Communication and Coordination : Collaborate with multi-functional team including medical, legal, R&D, QA. Ensuring timely updation of Veeva system.

Regulatory Intelligence: Monitor, collect and interpret regulatory issues, legislations, trends and other regulatory intelligence or i nsights that w i ll i mpact bus i ness, and communicate regu l atory risk assessment to the appropriate local and global teams.

External Affairs: Interface with relevant government agencies and key opinion leaders to assess the i mpact and i mplementation of requ i red compliance initiatives to meet all regulations, laws and industry policies that affect the i ngredients, packaging, marketing, advertising, labelling and production of assigned products.

Coaching: Provide training / coaching to team members on functional matters.

Regulatory Compliance: Ensure full compliance of all marketed products and marketing/sales activities with national regulatory requirements including but not limited to advertising, packaging and communications, and import/export procedures.

Communication Skills : Excellent verbal and written communication skills in English.

Interpersonal Skills: Strong interpersonal skills with the ability to lead and influence.

Technical Proficiency : Strong technical skills with a focus on regulatory compliance.

Collaboration and Leadership : Ability to work effectively in a matrixed, team-oriented environment, demonstrating leadership and collaborative skills.

Business Acumen : Understanding of business needs and customer sensitivity.

RA Expertise : In-depth knowledge of Regulations in India related to OTC drugs, ayurvedic products, nutraceuticals, and supplements.

Problem-Solving Skills : Ability to troubleshoot issues and implement systemic fixes.

Influencing Skills : Leadership and influencing skills across all organizational levels.

Collaboration Skills : Ability to collaborate effectively across functions and regions.