Regulatory Affairs Trainee Executive

Trainee Executive - Regulatory Affairs

Job Description

Drafting the regulatory submission files for domestic, emerging, and regulated markets.

Handling queries received from various health authorities.

Review of GMP documents as per the regulatory requirements.

Preparation of Post approval change (PAC) applications and other regulatory activities.

Coordination with the business partners for the marketing authorization applications in various geographies.

Understanding of regulatory requirements for biosimilar products is desirable.

Handling of online portals for various submissions in India, Emerging markets, and regulated markets.

Good oral and written communication are mandatory.

Work Experience

3-5 years of relevant experience

Education

Masters in Biotechnology or BiopharmaceuticsPost Graduation in Pharmaceutical Technology or Pharmacy

Competencies

Experience Level

Entry Level