Manager Regulatory Affairs

Job Location

Job Description

As a Regulatory Affairs Manager, you will be responsible for developing and executing regulatory strategy for assigned projects, ensuring compliance with applicable regulations for registered products and sites, providing an independent regulatory assessment for new projects, working in collaboration with multi-functional team for timely delivery of assigned tasks.

YOUR TEAM

You will report directly to the India Regulatory Head, working closely with cross-functional teams to enhance regulatory compliance.

HOW SUCCESS LOOKS LIKE

• 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.

RESPONSIBILITIES OF THE ROLE

• 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 ensuring 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 insights that will impact business, and communicate regulatory risk assessment to the appropriate local and global teams.

• External Affairs: Interface with relevant government agencies and key opinion leaders to assess the impact and implementation of required compliance initiatives to meet all regulations, laws and industry policies that affect the ingredients, 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.

Job Qualifications

Candidates must have a bachelor s or a postgraduate degree in Pharmacy/Bio Sciences/Chemistry and 8-10 years of relevant experience.

ROLE REQUIREMENTS

• 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.

PREREQUISITES

• 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.

ABOUT US

We produce globally recognized brands and we grow the best business leaders in the industry. With a portfolio of trusted brands as diverse as ours, it is paramount our leaders are able to lead with courage the vast array of brands, categories and functions. We serve consumers around the world with one of the strongest portfolios of trusted, quality, leadership brands, including Always , Ariel , Gillette , Head & Shoulders , Herbal Essences , Oral-B , Pampers , Pantene , Tampax and more. Our community includes operations in approximately 70 countries worldwide. Visit http://www.pg.com to know more.

We are an equal opportunity employer and value diversity at our company.