Reg Affairs Sr. Specialist

Sandoz India; Maharashtra; On-site; INR 1,200,000 - 1,800,000; Full time

Job summary

Sandoz India is seeking a seasoned regulatory affairs professional to lead and manage medium to small global submission projects. You’ll contribute to regulatory strategy, intelligence, and documentation to develop, register, and maintain global products.

The role involves coordinating across internal and external partners, and ensuring timely handling of regulatory events with agile, cross-border collaboration.

Qualifications

• Cross Cultural Experience.
• Functional Breadth.
• 6+ years of relevant experience
• Operations Management and Execution.
• Project Management.

Responsibilities

• Manages medium to small level global regulatory submission projects.
• Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
• Contribute to strategic and technical input /support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.
• Frequent internal company and external contacts.
• Represents organization on specific projects -Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Skills

Cross cultural experience

Functional breadth

6+ years of experience

Operations management

Project management

Job description

Your Key Responsibilities

Your responsibilities include, but not limited to:

• Manages medium to small level global regulatory submission projects.
• Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
• Contribute to strategic and technical input /support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.
• Frequent internal company and external contacts.
• Represents organization on specific projects -Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Essential Requirements

What you’ll bring to the role:

• Cross Cultural Experience.
• Functional Breadth.
• 6+ years of relevant experience
• Operations Management and Execution.
• Project Management.

Your Key Responsibilities

Your responsibilities include, but not limited to:

• Manages medium to small level global regulatory submission projects.
• Provide submission and contribute to the technical related regulatory strategy, intelligence and knowledge required to develop, register, and maintain global products.
• Contribute to strategic and technical input /support to drive implementation of global systems, tools and processes to support global development projects and/or marketed products.
• Frequent internal company and external contacts.
• Represents organization on specific projects -Works on problems of moderate scope where analysis of situations or data requires a review of a variety of factors.
• Reporting of technical complaints / adverse events / special case scenarios related to Sandoz products within 24 hours of receipt -Distribution of marketing samples (where applicable)

Essential Requirements

What you’ll bring to the role:

• Cross Cultural Experience.
• Functional Breadth.
• 6+ years of relevant experience
• Collaborating across boundaries.
• Operations Management and Execution.
• Project Management.

Skills

• Clinical Study Reports.
• Data Analysis.
• Documentation Management.
• Lifesciences.
• Operational Excellence.
• Regulatory Compliance.

Why Sandoz?

Generic and Biosimilar medicines are the backbone of the global medicines industry. Sandoz, a leader in this sector, provided more than 900 million patient treatments across 100+ countries in 2024 and while we are proud of this achievement, we have an ambition to do more!

With investments in new development capabilities, production sites, new acquisitions, and partnerships, we have the opportunity to shape the future of Sandoz and help more patients gain access to low-cost, high-quality medicines, sustainably.

Our momentum is powered by an open, collaborative culture driven by our talented and ambitious colleagues, who, in return for applying their skills experience an agile and collegiate environment with impactful, flexible-hybrid careers, where diversity is welcomed and where personal growth is supported!