lupin ltd

Regulatory Affairs Trainee Executive

lupin ltd
Pune
Not disclosed
Work from OfficeWork from Office
Full TimeFull Time
Min. 3 yearsMin. 3 years

Job Description

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

Job role

Work location
Work locationPune Biotech, MH, IN
Department
DepartmentLegal & Regulatory
Role / Category
Role / CategoryCivil Law
Employment type
Employment typeFull Time
Shift
ShiftDay Shift

Job requirements

Experience
ExperienceMin. 3 years

About company

Name
Namelupin ltd
Job posted by lupin ltd

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You can expect a minimum salary of 0 INR. The salary offered will depend on your skills, experience and performance in the interview.

The candidate should have completed the required education and people who have 3 to 5 years are eligible to apply for this job. You can apply for more jobs in Pune to get hired quickly.

The candidate should have sound communication skills and sound communication skills for this job.

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