Manager/Lead - Regulatory Affairs - Pharmaceutical Firm

We are looking for a Lead Regulatory Affairs who is specialized in Indian market regulatory affairs with good connections in DCGI for a Global Pharmaceutical MNC in Delhi / Bangalore

Job Description:

We are looking for a Regulatory Affairs Lead to lead regulatory processes for our assigned products, ensuring swift approvals and strict compliance with regulatory standards. In this role, you will develop and execute regulatory plans tailored to the Indian market, manage licensing processes, and provide leadership to project teams. Additionally, you will stay updated on regulatory changes, conduct competitive intelligence, and oversee quality assurance in GxP areas.

Key Responsibilities:

- Ensure adherence to company and industry regulatory standards and practices. Manage the complete licensing process for assigned products in compliance with regulations.

- Develop and implement regulatory strategies to expedite approvals and facilitate product launches.

- Provide leadership and guidance to project teams.

- Assist in managing regulatory issues as they arise. Stay updated on regulatory changes and actively shape the regulatory environment.

- Conduct competitive intelligence and analysis. Monitor and ensure compliance with GxP regulations.

Minimum Requirements:

- Degree in Pharmacy (M.Pharm/B.Pharm) with 10-14 years of experience in Indian regulatory affairs. Proficiency in dossier compilation and a strong understanding of Indian regulations.

Key Result Areas:

- Compliance with industry regulatory standards.

- Timely completion of licensing activities.

- Effective regulatory strategies for product approvals and launches.

- Leadership and support in issue management. Proactive engagement in shaping the regulatory landscape.

- Competitive intelligence gathering and analysis.

Internal Stakeholders:

- Marketing, Sales, Logistics, Medical, Legal Affairs, Intellectual Property, Global Product Teams (GPTs), Key Brand Teams (KBTs), International Regulatory Affairs (IRA), Manufacturing Sites, QA, Regional Office.

External Stakeholders:

- CDSCO Office, NIB, IPC, CDTL, CDL, NCB, DCK, other Local Health Authorities, Government Agencies, Manufacturers, Local Trade Associations, Legal Professionals.

Key Result Areas/Outputs Activities:

- Adherence to industry codes of conduct, ethics, and good regulatory practices:

- Embrace and embody company values and vision. Ensure compliance with local legislation, global regulatory policies, code of conduct, and audit requirements. Maintain confidentiality of company information and report any potential breaches.

Ensure that all licensing for assigned products is complete in accordance with relevant norms:

- Monitor the status of product licenses. Manage changes in product licenses and maintain documentation records. Communicate changes to license status promptly.

Develop and implement action regulatory plans for allocated products:

- Maintain in-depth knowledge of critical product aspects and align regulatory strategies with global priorities. Collaborate with stakeholders to develop plans and track approval status.

Provide leadership and direction within project teams:

- Foster high performance and accountability within the team. Cultivate commitment and positive attitudes, encourage continuous improvement. Assist in Issue Management:

- Provide regulatory status updates and undertake necessary follow-up actions.

Maintain Awareness of and Shape the Regulatory Environment:

- Engage with regulatory authorities, monitor external changes, and communicate impacts. Influence external stakeholders to improve regulatory outcomes. Build relationships and partnerships with Regulatory Authorities.

Competitive Intelligence and Analysis:

- Monitor competitor pipelines and provide strategic analyses. Identify trends and conduct risk-benefit analyses.

GRP Quality Lead:

- Ensure compliance with GxP regulations and allocate resources for activities. Provide training and coaching, identify compliance risks, and monitor KPIs. Communicate trends, risks, and maintain business continuity plans.