Regulatory Affairs Executive

Naukri Healthcare Jobs; India; On-site; INR 600,000 - 1,000,000; Full time

Job summary

Ruputed Pharmaceutical Company is seeking a Regulatory Affairs Executive in India with 2–5 years of regulatory affairs experience. The role focuses on developing regulatory strategies, preparing and reviewing documents for clinical trials and marketing authorizations, and collaborating with cross-functional teams to ensure timely submissions.

The ideal candidate will monitor regulatory changes, implement updates, and provide guidance on regulatory requirements.

Qualifications

• Bachelor's degree in Life Sciences or related field.
• 2+ years of experience in regulatory affairs, preferably in pharmaceutical industry.
• Strong knowledge of pharmaceutical regulations (FDA, EMA, ICH).
• Excellent communication and project management skills.
• Ability to work independently and with teams.
• Strong analytical and problem-solving skills.

Responsibilities

• Develop and implement regulatory strategies to ensure compliance with pharmaceutical regulations.
• Prepare and review regulatory documents, including clinical trial applications and marketing authorizations.
• Collaborate with cross-functional teams to ensure timely submission of regulatory documents.
• Monitor and analyze changes in regulatory requirements and implement updates.

Skills

Regulatory affairs expertise

Regulatory submissions

Document review

Cross-functional collaboration

Education

Bachelor's degree in Life Sciences

Job description

We are looking for a highly skilled and experienced Regulatory Affairs Executive to join our team at Ruputed Pharmaceutical Company. The ideal candidate will have a strong background in regulatory affairs, with 2-5 years of experience.

Roles and Responsibility

• Develop and implement regulatory strategies to ensure compliance with pharmaceutical industry regulations.
• Prepare and review regulatory documents, including clinical trial applications and marketing authorizations.
• Collaborate with cross-functional teams to ensure timely submission of regulatory documents.
• Monitor and analyze changes in regulatory requirements and develop plans to implement updates.
• Provide training and guidance to internal stakeholders on regulatory requirements.
• Maintain accurate records of regulatory interactions and submissions.

Job Requirements

• Bachelor's degree in Life Sciences or a related field.
• Minimum 2 years of experience in regulatory affairs, preferably in the pharmaceutical industry.
• Strong knowledge of pharmaceutical industry regulations, including FDA, EMA, and ICH guidelines.
• Excellent communication and project management skills.
• Ability to work independently and as part of a nested team.
• Strong analytical and problem-solving skills.