Ra Sr Associate

At Julphar, we are on a journey of culture transformation & our mission is to provide a better quality of life for the entire family by delivering best in class solutions and real value with compassion and professionalism.

Our core values: Respect, Collaboration, innovation, Integrity and Compassion - Combined with a focus on diversity, inclusion, and equal opportunities - are key drivers in our aim to make a positive impact on the lives of the patients we serve, enable Talents , create a healthy work environment, and accomplish our goals through world-class research and with the compassion and commitment of our employees.

Job Summary/Main Purpose

The RA Sr Associate must ensure to adhere to the cGMP principles and maintain them in an effective manner.

The regulatory affairs RA Sr Associate work description entails assisting in obtaining and maintaining government approval for materials such as drugs, medical devices, nutritional products, and several other related materials. Regulatory affairs specialists are also responsible for collecting, gathering, compiling, and preparing the dossier needed for registration and submission to regulatory agencies.

The regulatory affairs RA Sr Associate will report to Manager – Regulatory Affairs and efficiently conduct all duties and responsibilities assigned and or delegated by the Team Lead. Must ensure to support RA team members as per the need of the function.

Key Responsibilities & Key Result Areas

 Prepare, review, and submit regulatory dossiers for registrations, renewals, variations, and post-approval changes in CTD/eCTD format.

 Coordinate with health authorities for submissions, deficiency responses, follow-ups, and regulatory meetings.

 Ensure compliance with applicable regulations, guidelines, and internal SOPs; monitor and implement regulatory updates.

 Collaborate with Quality, Clinical, CMC, PV, and Supply Chain teams to support submissions, labelling, and lifecycle activities.

 Maintain regulatory records, submission trackers, and approval documentation.

 Support process improvements and provide guidance to junior regulatory team members.

Core Competency

• Strong knowledge of regulatory requirements and submission processes.
• Excellent written and verbal communication skills.
• Strong organizational skills with the ability to manage multiple priorities.
• High attention to detail and compliance mindset.
• Ability to work independently and collaboratively in cross-functional teams.
• Must have a teamwork attitude & ability to apply common sense understanding to carry out multi-step instructions
• Must be highly organized, self-motivated to learn new things and implement them at workplace
  
  

• Bachelors (4 years) / master’s degree in pharmacy
• Minimum 1-2 years of experience working in similar role in pharmaceuticals industry