Role Summary:
We are seeking an experienced Regulatory Affairs professional with strong expertise in biosimilar and complex formulations to lead regulatory documentation, support audits, and drive compliance strategies across biologics and advanced formulation programs. The role requires deep technical knowledge of upstream and downstream processes, as well as formulation complexities, along with proven experience in global regulatory environments.
Key Responsibilities:
Primary Responsibilities:
- Review and evaluate regulatory documentation related to biosimilars and complex formulations.
- Provide subject matter expertise in molecular biology, including upstream and downstream bioprocesses, as well as complex formulation development.
- Drive regulatory strategies and ensure compliance with global guidelines (e.g., USFDA, EMA) for biologics and complex drug products.
- Oversee preparation and submission of regulatory dossiers related to biosimilar drug substance and products, complex formulations, and technology transfer.
- Provide strategic input and technical oversight for upstream and downstream process development, formulation development, and scale-up.
- Collaborate with cross-functional teams (R&D, Manufacturing, QA, QC) to ensure regulatory alignment across biologics and complex formulation programs.
Secondary Responsibilities:
- Mentor and guide junior team members on regulatory requirements, including biosimilars and complex formulations documentation practices.
- Manage communication with internal stakeholders and ensure timely resolution of technical and regulatory queries.
- Plan, prioritize, and track regulatory activities to meet project timelines.
- Promote a collaborative and high-performance team environment.
Qualifications & Experience:
- M.Sc. / M. Tech in Biotechnology or related life sciences discipline.
- 8–12 years of relevant experience in regulatory affairs within the biologics/biosimilars and complex formulations domain.
Key Skills & Competencies:
- Strong leadership and stakeholder management skills.
- In-depth knowledge of global regulatory frameworks for biologics and complex drug products.
- Excellent technical writing and documentation skills.
- Strong communication, problem-solving, and decision-making abilities.
- Ability to work in a fast-paced, cross-functional environment.
