Senior Specialist Regulatory Operations

Hemofarm is a member of STADA Group, one of the largest global generic pharmaceutical companies, which successfully operates in both the markets of Serbia and Western Balkans. Hemofarm produces high quality pharmaceutical products within the leading pharmacotherapeutic groups, observing the key corporate values: Agility, Integrity, Entrepreneurship and ONE STADA.

Our Regulatory Operations Team is looking for:

Senior Specialist Regulatory Operations

Place of work: Vršac

Requirements:

• University degree or completed vocational training,
• Relevant experience in the field (Pharma IT, IT Support, Regulatory IT),
• Fluent English both verbally and in writing,
• Strong communication skills, analytical, proactive team player, able to make decisions on subproject level,
• Self dependent and independent work with ability to work in an agile environment,
• Advanced knowledge of IT support processes,
• Understanding of quality assurance,
• Intermediate knowledge of databases and database structures,
• Fundamental knowledge in Regulatory Affairs is a plus,
• Fundamental knowledge of regulatory electronic submissions and other electronic data transfer (xEVMPD, IDMP) is a plus.
• Reference: WYNwTsfbP7BOwPASaYUSiChgZn2x_KZCYzo9bjW_GoA.

Your duties would include:

• Active contribution and sharing of knowledge and ideas for the ongoing improvement of departmental business processes,
• Administration and maintenance of the software used in the field of Regulatory Affairs,
• Guideline-compliant accomplishment of regulatory tasks for the electronic dossier submission and other electronic data submissions to regulatory authorities,
• Data Quality Management, data entry and data cleansing,
• Standard Application Service Requests, Application- & Business Service Execution,
• Develop & review procedure documents,
• System-wide responsibilities in international First Level Support:
  1. Acceptance of support tickets or calls,
  2. Issue classification according to existing scope definition,
  3. Independent solution of issues accoding to Best Practice Guides or procedure documents,
  4. Creation of tickets and allocation to Second Level Support,
  5. Maintaining Best Practice Guides or procedure documents,
• System-specific tasks in Second Level Support: independent solution of complex admin tasks on Subject Matter Expert Level
  1. Advice of international users on process issues,
  2. Analysis and solving of process problems,
  3. Maintenance of code lists, libraries, master data, etc,
  4. Creation of user groups and assignment of permissions,
  5. System reboots,
• Support for training management and logistics.

We offer:

• Diverse, challenging and responsible tasks.
• Possibility of promotion and achieving a career progression.

For further information on Hemofarm, please visit the website hemofarm.com and