Global Regulatory Affairs Specialist

Job summary

This role involves coordinating regulatory master data across global functions to ensure compliance and support market access for enzyme products. The position is part of a team focused on regulatory affairs within the biosolutions sector, particularly for projects in India.

Qualifications

• Bachelor’s and master’s degree in Life Sciences, Regulatory Affairs, Biotechnology, Chemistry, Microbiology, Biology, or a related scientific field.
• 4–5 years of relevant experience in regulatory affairs, preferably in the biotechnology industry.

Responsibilities

• Serve as the primary contact for regulatory master data, ensuring alignment and timely availability for regulatory activities.
• Maintain accuracy and compliance of regulatory master data across systems.
• Provide regional teams with reliable master data for efficient regulatory submissions.
• Collaborate with various internal stakeholders to ensure accurate data flow.
• Navigate complex regulatory environments to support decision-making.

Skills

• Strong written and verbal communication skills in English.
• Analytical and problem-solving abilities with attention to detail.
• Experience with regulatory information management systems.
• Ability to manage multiple priorities and build stakeholder relationships.

Education

• Bachelor’s and master’s degree in relevant scientific disciplines.

Tools

• Familiarity with regulatory information management systems and digital platforms.