Regulatory Affairs Support:

• Developing the regulatory strategy including Filling readiness of NDA’s & sNDA.
• Responsible for ongoing renewals, variations and maintenance of registered products and CDx (devices).
• Collaborating with global teams during early stage of product development and share the inputs on regulatory requirements from development and data perspective.
• Understand timelines of the availability of various documents for filling application and supply chain of the new product for which regulatory strategy is been created.
• Understand likely queries and keep documents ready in advance to either share the same to prevent the query or to have short lead time in submitting query response.
• Maintain an awareness of country’s regulatory legislation.
• Monitor progress of marketing applications through the regulatory system.
• Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.
• Monitor SEC recommendation and CTRI on Reg Intel information on the registration.
• Contribute in Regulatory Policy related matters by providing inputs for draft guidelines / Regulations.

Business Support

• Responsible independently new product regulatory strategy discussion with area regulatory, responsible collaboration with commercial team for launch plan, managing product lifecycle maintenance activities viz variation submissions, labelling updates, renewals, testing of samples as per stipulated timelines and in line with company and Health Authority set standards for the assigned countries. Working with NPI team for product launch plan and establishing country specific artwork.
• Develop and implement regulatory strategies, identify potential regulatory risks and develop mitigation strategies, ensure compliance with labeling, advertising, and promotional regulations, Review and approve labeling, advertising, and promotional materials to ensure compliance with local regulations and guidelines, Collaborate with marketing and sales teams to ensure accurate and compliant communication of product information. Stay updated with any changes in labeling, advertising, and promotional regulations and provide necessary guidance and training to relevant teams. Provide regulatory input on marketing campaigns and strategies to ensure accurate and compliant product claims.
• Attend ARPT /GRPT and Keep up to date for product registration, variation, line extension and other related law & regulations knowledge.
• Monitor and disseminate information on changes related to the Regulatory Authority Department: law & regulations affecting registration, manufacture, distribution and sale & marketing of AbbVie products.
• Facilitate communication between Area Regulatory lead and the local regulatory authority.
• Monitor the progress of marketing applications and provide updates on registration status during brand team meetings, as applicable.
• Identify potential regulatory hurdles or challenges and work collaboratively to address them.
• Provide regulatory input and support for marketing plans, product launches and other cross- functional activities.
• Review and provide input and approval on promotional materials, product information and labels for regulatory compliance.
• Provide support to Institutional business support as and when required to acquire documents viz. Market Standing Certificate, No Conviction Certificate GMP, Manufacturing License and Proprietary Article Certificate etc.

RA Process

• Regulatory submissions and approvals in the most efficient and cost-effective manner for assigned products and countries.
• Ensure 100% compliance to internal processes and policies and also Health Authority requirement.

RA Compliance                                                                                                                     

• Ensure compliance with local requirements and company policy, such as timely notification to Area of local renewal requirements. Implement remediation plan to address identified gaps.
• In collaboration with cross-functional groups, e.g. Legal, Medical, Pharmacovigilance, Quality and supply chain to ensure the compliance with relevant legal/regulatory requirements and reviewing and approving promotional materials as per the approved labels.
• Up to date of product registration, variation, line extension and other related law & regulations knowledge.
• Review, analyze and co-ordinate data for variations submission to marketed products according to priorities and responses to deficiency letters.
• Monitor progress of variations approval process within Regulatory Authority.
• Liaise and negotiate with the relevant authorities to facilitate and secure expeditious regulatory approvals.
• Manage labeling changes, artwork development and artwork approval of packaging material components.
• Update and maintain regulatory databases.

Key Relationships

• External: Health Authority, Distributors, & Consultants
• Internal: RA, Medical Affairs, Drug Safety, Global Regulatory and Clinical development functions, Market Access, Marketing, Quality assurance, etc.