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.

RA Sr. Associate – the role holder will be responsible will be responsible to arrange and coordinate the collection of information, documentation and compile into submissions. Gap analysis for registered products and follow up requested documents from different departments to fulfill dossier compilation and queries raised by different health authorities.

Responsible for the review of labeling, registered product development and manufacturing documents for compliance with regulatory requirements. Establish filling system, and record keeping including scanned documents required by different health authorities and keep records of all the registered products across the globe in SAP. Accountable for all coordination tasks between the department and cross-functional departments.

Key Responsibilities & Key Result Areas

• Responsible to follow up of documents required from departments for regulatory file submissions.
• Review labeling and labels for compliance with regulatory filings.
• Prepare the required certificates & arrange for the legalization as per the requirements of the different countries.
• Prepare renewal, variation and response dossiers as per country requirements
• Review of internal document system & perform GAP analysis as per country specific requirements.
• Maintain accurate records and establish filling system for tracking of renewal, variation and response files in designated folders for future references and easy retrieval of information
• Update monthly the product feasibility and prepare monthly report as well as annual report.
• Responsible to arrange folder in the computer including the scanned documents, API documents, CPP, GMP & etc. and update the list of the expiry Date of the Registration Certificates.
• To provide approved API supplier, packaging material details to Manager in order to support compliance system
• Stay current on changes in regulations and guidance and maintain current knowledge of regulation, guidance and standards applicable to Julphar products.
• Create and manage database for all the registered products across the globe and update timely the same using SAP.
• Update timely the price and shelf life in SAP, also arrange the price certificates for different countries as required for registration renewals.
• Associate to the concerned departments about new registration; renewals & variations approved by different health authorities.
• Preform any other work assigned by manager and support colleagues whenever necessary.
  
  

Core Competency

• In terms of competency you are highly result oriented with strong sense of accountability & ownership.
• Ability to prioritize, multi-task and work effectively under pressure to meet deadlines.
• Good communication, interpersonal and collaboration skills.
• Highly disciplined and must be organized, self-motivated to learn new learnings and implement them at workplace
• Strong attention to details, proactive and flexible approach.
• Good implantation skills and easily adapt to changing situations.
• Must be able to work in a cross-functional environment interacting with other internal and external departments
• Must be able to communicate technical, scientific, and regulatory information, both written and verbally.
  
  

Qualifications / Key Experiences / Functional Knowledge Requirements

• 4 years Bachelor Degree in Science/ any equivalent field/ Diploma in similar field.
• At least 1-2 years’ experience in similar organization in pharma / Health care / Medical Industry.
• Should have handled similar position for a better fitment in this role
• Good in communicative English (communicating, writing and speaking) is mandatory & Arabic as advantage.
• Excellent in MS Office (MS Excel and MS Word, etc.).
• Proven experience in managing complex and sensitive data.
• A Strong knowledge in Regulatory Affairs and its related activities like - New Registrations, variations renewals etc.
• Good Knowledge of specific regulatory discipline and principles, concepts, and governing Regulatory Affairs.
  
  

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