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 with the cGMP principles and to 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 Manager – Regulatory Affairs. Must ensure to support RA team members as per the need of the function.
  
  

Key Responsibilities & Key Result Areas

• The major duties, tasks, and responsibilities that typically make up the regulatory affairs RA-Sr. Associate job description are listed below:
• Explaining regulations, policies, or procedures
• Ensuring adequate compliance with regulations
• Advising others on matters that are related to regulatory processes and compliance
• Providing correct and accurate technical review of data or reports
• Overseeing the planning, coordination, and management of regulatory documentation activities
• Examining, identifying, and interpreting relevant regulatory guidelines
• Analysing and evaluating laws and regulations that apply to the process of determining the impact on company activities
• Compiling and overseeing the maintenance of regulatory documentation databases or systems
• Coordinating efforts that are related to the preparation of regulatory documents or submissions
• Developing and maintaining healthy communication with regulatory agencies regarding pre-submission strategies, compliance test requirements, potential regulatory pathways, or clarification, and follow-up on submissions still under review.
  
  

Core Competency

• High on communication and collaboration, having an ability to manage multiple stakeholders at a time
• In terms of competency you are highly result oriented with strong sense of accountability & ownership.
• Must be able to manage tasks and priorities and easily adapt to changing situations.
• Good command in English (Communicating, writing and speaking)
• Good prioritizing skills and being able to make a just decision also in case of (time) pressure;
• Proficiency in Microsoft Office particularly in Excel, PowerPoint and Word.
• Strong organizational skills and the ability to multitask
• Demonstrated ability in working independently and as part of a team
• Must be able to work in a cross-functional environment interacting with other internal departments and external vendors
• 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.
  
  

Qualifications, Key Experiences / Functional Knowledge Requirements

• Bachelors (4 years) / Master’s Degree in Pharmacy
• Minimum 1-2 years of experience working in similar role in Pharmaceuticals industry
• A Strong Background in Regulatory Affairs and its related activities like - New Registrations, variations renewals etc.
• Has strong knowledge of regulatory guidance in multiple regions and industry best practices for drug development.
  
  

We value people from different backgrounds. Could this be your story? Apply today or visit www.Julphar.net to read more about us and the journey of Julphar.