Regulatory Affairs Team Lead require at Colgate-Palmolive

Colgate-Palmolive is a leading global consumer products company, tightly focused on Oral Care, Personal Care, Home Care and Pet Nutrition. Colgate sells its products in over 200 countries and territories around the world under such internationally recognized brand names as Colgate, Palmolive, elmex, Tom’s of Maine, Sorriso, Speed Stick, Lady Speed Stick, Softsoap, Irish Spring, Protex, Sanex, Elta MD, PCA Skin, Ajax, Axion, Fabuloso, Soupline and Suavitel, as well as Hill’s Science Diet and Hill’s Prescription Diet.

Post : Team Lead - Regulatory Affairs

Job Description
Job Purpose
The position will lead and manage the Regulatory Operations team based in Mumbai that is responsible for supporting the Africa-Eurasia (AEA) & North Africa Middle East & Turkey (NAMET) regions, and provide functional leadership with the implementation of systems and procedures used to support regulatory submissions, notifications, certifications and ingredient list creation activities, and other operational activities on a day-to-day basis. This position will manage a team of Regulatory Affairs (RA) Associates by providing ongoing coaching, guidance, mentorship and leadership. This position will report to the Manager of Global Regulatory Operations.

Key Responsibilities
• Collaborate with RA Managers on programs and activities within AEA & NAMET regions to align on priorities and product registrations.
• Manage RA Associates supporting roles by coordinating the efforts of the operational regulatory team based in India.
• Support the regulatory strategy defined at Regional and/or Global level, and report regularly the progress to the Regional RA Department with relevant KPIs, particularly in terms of timelines, status of supportive data required from other functions and dossier preparation.
• Manage compilation of required documents from source countries for high quality and successful submissions, license renewals, annual registrations and maintenance of product registration dossiers for authorities.
• Ensure content, organization and overall quality of all regulatory documents and samples are adequate and stay in sync with local/regional regulatory requirements, commitments and agreements.
• Manage dossiers and document storage for country registrations for easy reference.
• Manage AEA/NAMET registration database and prepare documentation for registrations required for products manufactured globally and distributed in these regions.
• Maintain and update the master registration tracking tool with existing, new and pending registration information.
• Coordinate Global Regulatory Assessments and ensure completion in a timely manner.
• Assist RA Regions with artwork approval with regards to confirmation of INCI lists, registration numbers, review of product labeling and promotional material to ensure compliance with proof of claims.
• Remain updated on changes with International Standards related to products and processes to ensure compliance. Provide feedback to country specific RA Managers.
• Provide mentoring and training to RA and cross-functional team members
• Build relationships with the regional/country Regulatory Teams so as to maintain effective communication and address issues on an ongoing basis.

Candidate Profile
• Bachelor’s degree in Pharmacy or Life Sciences or relevant education.
• At least 4 years of relevant experience in regulatory affairs, quality or product development in pharmaceutical, medical devices or similar FMCG/CPG companies.
• Understanding of registration and regulatory requirements.
• Knowledge of industry practices, techniques and standards.
• Knowledge/understanding/experience in the following legislations and fields would be an added value
• Excellent digital literacy which includes working on electronic databases, Google tools and MS office applications.
• Flexible with priorities and responsibilities.
• Effective interpersonal skills and attention to detail.
• Works well under pressure in a multifaceted environment.
• Excellent prioritization and time management skills.
• Effective communication skills, both written and oral, with excellent interpersonal skills.
• Fluent in spoken and written English. Knowledge of additional languages is an advantage.
• High degree of self-awareness in coordinating with global clients and managing a team.
• Ability to drive global projects by actively leading such projects and providing innovative solutions.
• Ability to resolve conflicts creatively by anticipating issues and proactively working on solutions.
• High level of awareness about cultural nuances and sensitivities of the regional teams with whom this position will coordinate.

Additional Information
Experience : 4 years of experience
Qualification : Bachelor’s degree in Pharmacy or Life Sciences
Location : Mumbai, Maharashtra
Industry Type : Pharma/ Healthcare/ Clinical research
Functional Area : Regulatory Affairs
End Date : 30th May, 2022