International Regulatory Affairs Specialist

4 days ago

Mumbai, Maharashtra, India beBeeRegulatoryAffairs Full time US$ 40,000 - US$ 80,000
Job Description:

As a regulatory affairs professional, you will play a key role in ensuring the timely submission of regulatory documentation for assigned projects. Your primary responsibilities will include collating, compiling, and dispatching regulatory documents to Apotex affiliates/customers, as well as following up on the timely submission of applications to health authorities.

You will be responsible for maintaining accurate records in global regulatory databases, updating established trackers, and ensuring the accuracy of information. Additionally, you will need to adhere to the responsibilities assigned to you, act as a backup for team members, and support other projects as needed.

Key Responsibilities:

  • Collation, compilation, and timely dispatch of required regulatory documentation to Apotex affiliates/customer and follow-up on timely submission of applications to the health authority.
  • Timely communication and follow-up with respective departments for compilation of tender submissions and database updates.
  • Respond to queries received from Apotex affiliates/customer and health regulatory agencies on regulatory submissions.
  • Maintain records in global regulatory databases, update established trackers & status sheets, and ensure accuracy of information.
Required Skills and Qualifications:

A Graduate/Postgraduate in Pharmacy is essential for this role. You should have good academic background knowledge about New Product Dossier and PLCM submission requirements will be an additional advantage. The ideal candidate should have 0-1 years of regulatory affairs experience in International markets.

Benefits:

This role offers the opportunity to work in a dynamic and fast-paced environment, where you will be able to apply your skills and knowledge to contribute towards the success of our organization. You will have the opportunity to work collaboratively with a talented team, develop your career, and gain valuable experience in regulatory affairs.

Other Opportunities:

  • Completion of all assigned trainings in a timely manner.
  • Contribution towards creating and promoting an environment of teamwork and empowerment built on mutual trust and respect.
  • Working in a safe manner, collaborating as a team member to achieve all outcomes.
  • Demonstration of behaviours that exhibit our organizational values: Collaboration, Courage, Perseverance, and Passion.
  • Personal adherence with all compliance programs including the Global Business Ethics and Compliance Program, Global Quality policies, Safety and Environment policies, and HR policies.

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