Drug Regulatory Affairs Specialist

Job Description:

1. We are seeking a motivated and detail-oriented Drug Regulatory Affairs (DRA) Specialist to join our dynamic team. As a DRA Specialist, you will be responsible for ensuring compliance with local and   international  regulatory requirements for our pharmaceutical products. Your role will involve preparing and submitting regulatory filings, managing regulatory submissions, and liaising with regulatory agencies to expedite approvals.

  Key Responsibilities:

   Prepare and compile regulatory submissions for new products, variations, renewals, and registrations.

   Review and assess scientific data to ensure compliance with regulatory standards.

   Liaise with cross-functional teams (R&D, manufacturing, quality assurance) to gather necessary information for regulatory submissions.

  Monitor regulatory guidelines and ensure updates are communicated internally to maintain compliance.

  Provide regulatory guidance to internal teams to support product development and commercialization strategies.

  Maintain accurate regulatory documentation and records.

   Participate in regulatory audits and inspections as required.

Qualifications

   Bachelor’s degree in Pharmacy, Life Sciences, or related field, Advanced degree (Masters or PhD) preferred.

  2+ years of experience in Drug Regulatory Affairs within the pharmaceutical industry.

  In-depth knowledge of regulatory requirements and guidelines (FDA, EMA, etc.).

  Strong analytical and problem-solving skills.

  Excellent communication and interpersonal skills.

  Ability to work independently and as part of a team in a fast-paced environment.

   Benefits:

  Competitive salary and benefits package.

  Opportunity for professional growth and development.

  Collaborative and innovative work environment