Robin Johnson Email & Phone Number

Bengaluru, Karnataka, India

1. Responsible for providing strategic regulatory expertise for submissions 2. Liaising with cross-functional teams to define development strategy3. Provide expert recommendations and decisions on regulatory issues relating to CMC4. Identifying potential risks along with mitigation strategies 5. Participating in agency meetings6. Providing clear direction and guidance in regulatory matters to team members7. Developing and mentoring the team8. Member of Regulatory Leadership team

Bangalore Urban, Karnataka, India

Bengaluru Area, India

1. Preparing regulatory strategies for assigned countries/regions2. Planning and leading the team towards regulatory submissions including new product licenses to life cycle management and query responses3. Lead strategic interactions with Health/Regulatory Agencies for regulatory activities4. Lead for assigned biosimilar products; responsible for providing regulatory inputs for the development of the products throughout its lifecycle

Hyderabad Area, India

1. Planning and leading the team towards regulatory submissions including new product licenses to life cycle management and query responses2. Preparation of dossiers including Administrative, CMC, Non-clinical and Clinical sections3. Regulatory Lead for partnered projects to support regulatory activities

Bengaluru Area, India

1. Leading team to prepare and compile CMC dossiers for CTA (Phase I & III) for E.U., U.S. & India along with CMC Scientific Advice packages for E.U. & U.S. 2. Preparing responses to queries received from FDA or EMA3. Providing regulatory strategies and support on CMC aspects for biotechnological/biological products (e.g. Process Validation, Stability testing for bulk and finished products, In-process tests/controls during manufacturing etc.)4. Reviewing technical documents

Master'S Degree

Bachelor Of Technology (B.Tech.)

Class 12 (Aissce)

Class 10 (Aisse)