Work as Regulatory Affairs Associate at Colgate-Palmolive @ Mumbai
Post : Associate – Regulatory Affairs
Responsibilities may vary from time to time depending on the need. The range of responsibilities and accountabilities may include, but not limited to the following:
• Responsible, in alignment with the internal client, for mapping each of the processes that are transitioned to the Operations team with clear roles & responsibilities between the Operations team and the internal Global Regulatory client.
• Responsible for delivering meaningful KPIs in alignment with the entire Operations team
• Work closely with and support South Pacific & India Hub Regulatory Affairs programs and activities for new product registration and life-cycle management of CP portfolio, including but not limited to, product renewals, variations, notifications and/or new license applications.
• Support the regulatory strategy defined at South Pacific & India Hub Regulatory Affairs level, and report regularly the progress with relevant KPIs, particularly in terms of timelines, status of supportive data required from other functions and dossier preparation.
• Work closely with global and regional cross functional teams and South Pacific/Indian-hub Regulatory to obtain the relevant documents and information for product dossiers.
• Compile documents and information required for high quality and successful submissions, license renewals and annual registrations, and maintenance of product registration dossiers for authorities.
• Assist the South Pacific & India Hub Regulatory Affairs in preparing submissions to Competent Authorities and Notified Bodies, ensuring timely approval of new products and life-cycle submissions.
• Track outstanding documentation and notify the relevant Hub Regulatory Affairs Manager in a timely manner.
• Inform Hub Regulatory Affairs Manager of upcoming renewals and commitments in a timely manner.
• Assist in the electronic submission of product dossiers, variations and responses to Competent Authorities.
• Update and maintain product registration and ingredients archives, databases and tracking tools.
• Upload and publish electronic Common Technical Document (eCTD) sequences for medicinal products.
• Upload and maintain technical files/dossier databases for the products.
• Upload and maintain as required by the relevant Hub RA team any documentation supporting the placing on the market of other categories of products eg cosmetics, home care, consumer goods
• Assist in the preparation of Regulatory Standard Operation Procedures, and in keeping track of revision dates.
• Manage the distribution lists of SOP and the archiving in the documentation system (DMS).
• Ensure proper electronic archiving of all documents submitted to and received from Competent Authorities and Notified Bodies, as well as accurate and timely data update of regulatory compliance databases and tools for assigned products.
• Assist the South Pacific/India Affairs Managers in the review of list of ingredients for labeling purposes (eg. INCI and INDI).
• Assist the RA Managers with artwork review and approval
• Understand current regulations, guidelines and standards relevant to ensure compliance of dossiers/submissions to the applicable regulatory and corporate standards/requirements (medicinal products, medical devices, cosmetic products, home care products, etc.)
• Ensure that the content, organization and overall quality of all regulatory documents are adequate and compliant with local/regional regulatory requirements, commitments and agreements.
• Track Competent Authority websites and databases for news related to regulatory developments.
• Assist regional regulatory team to coordinate, manage and deliver completed RA assessments and routine regional regulatory project reports.
• Assist the South Pacific/India Hub regulatory teams in regional or global projects as required.
• Bachelor’s degree in Pharmacy or Life Sciences or relevant education.
• Minimum 1 year 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 in the South Pacific/Indian-hub is preferable.
• Knowledge and experience with medicinal products and medical devices is an advantage.
Experience : 1 year
Qualification : BSc, B.Pharm
Location : Mumbai
Industry Type : Pharma
End Date : 10th October, 2020
Mr. Shiv Kumar is the Author and founder of pharmaceutical guidance, he is a pharmaceutical Professional from India having more than 14 years of rich experience in pharmaceutical field.
During his career, he work in quality assurance department with multinational company’s i.e Zydus Cadila Ltd, Unichem Laboratories Ltd, Indoco remedies Ltd, Panacea Biotec Ltd, Nectar life Science Ltd. During his experience, he face may regulatory Audit i.e. USFDA, MHRA, ANVISA, MCC, TGA, EU –GMP, WHO –Geneva, ISO 9001-2008 and many ROW Regularities Audit i.e.Uganda,Kenya, Tanzania, Zimbabwe. He is currently leading a regulatory pharmaceutical company as a head Quality. You can join him by Email, Facebook, Google+, Twitter and YouTube