Job Description

The Position
To Manage & execute the local RA activities according to ROPU RA strategies and local business priorities within the defined timelines. Maintain product registrations and RA databases, ensuring business continuity in compliance with internal and external regulations and requirements. Provide regular regulatory intelligence on changes in regulatory environment, competitor activity and opportunities to enable the business to realize risk or opportunities arising in the RA environment. Collaborate cross-functionally and make sure that all relevant stakeholders are timely and pro-actively updated on relevant RA topics. Have a strong interaction and partnership with the assigned authorities across in the OPU/cluster. Maintain efficient relationships with related Regulatory service Providers (local agents and vendors). Carry out agreed actions for the assigned local projects. Can deputize the OPU RA Head in external & internal stakeholders' engagement as required. Support the OPU RA head in the continuous development of the team.
Tasks & Responsibilities

• Timely execution of RA activities as per the META strategy and the OPU business priorities.
• Compilation of the dossier as per local regulations and requirements.
• Maintain MA and support product shipments.
• Engagement with local graphic offices (if applicable) and maintenance of RA databases.
• Tracking and archiving the acknowledgments/dossier in hard and soft copies on common drive.
• Involved in Budget preparation.
• Deputize OPU Head of RA in escalation discussion for product and non-product local topics to ROPU.
• Encourage innovation in our daily activities.
• Communicate and discuss new/updated information within regulatory environment, competitive regulatory intelligence and/or new requirements in the country with the OPU and META stakeholders.
• Support to compile the required regulatory expertise to support future BI portfolio.
• Adherence to BI SOPs, ROPU processes and local regulations.
• Contribute to CAPA process as appropriate.
• Perform day-to-day tasks with expected Quality.
• Contribute in risk/crisis management.
• Health Authority Interactions.
• Maintain successful Regulatory service Provider (RSP) relationship.
• Implement the OPU cross-functional interaction plan.
• Be a valued partner to other functions in Human Business Pharma (e.g. ClinOps, Market Access, Marketing, Medicine, PV, Legal, Supply Chain, Communication, QM, etc.), empowering them to understand the regulatory requirements and implications for their business area.
• Participate actively in the Brand teams & other related brand meetings.
• Provide timely input to line manager on topics supporting ROPU and Global projects.
• Provide regulatory Intelligence to line manager to support local project team (where applicable).
• Active sharing of regulatory expertise/experience with local regulatory team.
• Prioritize personal development as per competency framework and business need
• Practice innovation mindset and operational excellence.
• Direct influence on new drug application in the scope of assigned TA responsibility and consequently the relevant launch. Ensure assigned product license validity to secure sustainability of the current business.
• Advise Local OPU RA head on arising business opportunities that can Support local to accelerate both patient access to BI innovative solution and business growth.
• Execute business priorities for product of responsibility , achieve timelines for assigned RA projects and enable OPU to support ROPU to realize the brand growth & achieve the targeted values.
• Fully accountable for the performance in execution of assigned product regulatory activities & able to take actions and decisions to achieve the agreed objectives.
• Able & empowered to take decisions on behalf of the OPU RA head in particular situations as assigned.
• Contribute to securing the OPU LTF figures and budget for the assigned product responsibility and achieve targeted business growth.
• Responsible for providing the RA activity fees and keeping within this limit to support OPU budget calculations & support OPU RA Head in budget consolidation.

Requirements

• Education: Bachelor's degree in pharmacy or similar medical education
• Pharma experience with regulatory focus in a multi-national for at least 4-6 years.
• Experience of direct interactions with Regulatory Authorities.
• Prior people management experience is an asset.
• Skills and competencies should match at least the entry level of the Competency frame work for the OPU Manager RA.
• Demonstrating RA knowledge, critical thinking and problem solving.
• Leading by example and demonstrating sound business acumen.
• Demonstrating cross functional collaboration & accountability
• Effective negotiation and communication and agility to changes.
• Solid understanding of D&C Act and Rules.
• Understanding of working practices at HA.
• Position is based at Mumbai

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