Regulatory Affairs Professional

2 days ago

Hyderabad Secunderabad Telangana, India beBeeRegulatoryAffairs Full time ₹ 1,04,000 - ₹ 1,30,878
Job Overview

This role plays a critical part in the success of our organization by ensuring compliance with regulatory requirements and facilitating the efficient approval of drug products.

We are seeking a highly skilled Regulatory Affairs Associate to join our team. In this position, you will be responsible for preparing generic drug product submissions for Health Canada, reviewing and evaluating deficiency responses, and maintaining current awareness of regulatory guidelines.

Key Responsibilities
  • Prepare high-quality generic drug product submissions for Health Canada, adhering to format and content requirements.
  • Review and evaluate deficiency responses from Health Canada, ensuring timely and accurate submissions.
  • Maintain current awareness of regulatory guidelines, including Health Canada and ICH regulations.
  • Evaluate change requests and contribute to the implementation of post-approval changes.
  • Interpret scientific data and conclusions from CMC reports and summaries.
  • Communicate effectively with internal stakeholders and external partners, attending and organizing meetings as necessary.
Required Skills and Qualifications

To succeed in this role, you will need:

  • Demonstrated oral and written communication skills, with the ability to communicate complex issues clearly and concisely.
  • Strong understanding of Health Canada and ICH regulatory guidance documents and policies.
  • Proficient computer skills, including MS Office applications and Adobe Acrobat.
  • A university degree in Science or Life Sciences and post-graduate certification in Regulatory Affairs program.
  • Preferably 2 years of experience in drug submissions for Canada, preferably with parenteral dosage forms.
What We Offer

We offer a dynamic work environment, opportunities for professional growth and development, and a competitive compensation package.

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