Regulatory Affairs Executive (2-3 Years)

As a Regulatory Affairs Executive, you will be responsible for ensuring that our products meet regulatory requirements and standards. Your role will involve various tasks related to compliance and coordination with different departments.

Key Responsibilities:

- Regulatory Submission Preparation: You will prepare and submit regulatory documents to authorities, ensuring all submissions are complete and accurate to facilitate timely approvals.

- Regulatory Compliance Monitoring: Regularly monitor updates and changes in regulations to ensure our products and processes remain compliant with industry standards and guidelines.

- Collaboration with Cross-Functional Teams: Work closely with the research, quality assurance, and production teams to gather necessary information for regulatory submissions and to address compliance issues.

- Product Lifecycle Management: Assist in managing the lifecycle of products, from development through registration to post-market surveillance, ensuring compliance throughout.

- Maintaining Regulatory Documentation: Organize and maintain regulatory files and documentation, ensuring they are up-to-date and easily accessible for audits and inspections.

- Conducting Risk Assessments: Evaluate potential risks associated with regulatory compliance and develop strategies to mitigate these risks effectively.

Required Skills and Expectations:

- A Master's degree in Pharmacy (ma) is essential, reflecting a strong foundation in pharmaceutical sciences.

- Candidates should have 2-3 years of experience in regulatory affairs or related fields, demonstrating hands-on experience in managing regulatory processes.

- Strong understanding of regulatory requirements, guidelines, and industry standards is crucial for ensuring compliance.

- Excellent attention to detail and strong analytical skills to evaluate complex regulatory information effectively.

- Good communication and interpersonal skills are necessary to liaise with various stakeholders and present regulatory submissions clearly and concisely.

• Experience

  2 - 3 Years

• No. of Openings

  1

• Education

  Post Graduate (M.Pharma)

• Role

  Regulatory Affairs Executive

• Industry Type

  Pharma / BioTech / Clinical Research

• Gender

  [ Male / Female ]

• Job Country

  India

• Type of Job

  Full Time

• Work Location Type

  Work from Office

• Face Interview Location

  Impact HR and KM Solutions Near Canada Corner Signal Ravi Chambers Basements Below Laminate Gallery, Nashik