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Junior Regulatory & Medical Affairs Associate

📁
Research & Development
💼
Romania
Thanks for your interest in the Junior Regulatory & Medical Affairs Associate position. Unfortunately this position has been closed but you can search our 591 open jobs by clicking here.

 

A fantastic opportunity for Junior Regulatory & Medical Affairs Associate to join our team

 

Main objectives of the Junior Regulatory& Medical Associate are:

  • To Provide medical and scientific support to develop successfully medical, marketing & regulatory projects and launches for Medicines, Medical Devices, Cosmetics, and Food Supplements
  • Prepare Medical training for Business, Sales Force, Detailing teams and Marketing as needed.
  • Developing and managing relationships with the detailing teams, trade associations, and patients’ organizations on scientific/medical topics and Support them in medical inquiries
  • Driving and ensuring Healthcare Compliance processes 
  • Assuming the Scientific Responsible Role in front of Health Authorities and being the key contact in case of internal or external audits from Health Authorities if the scope of the audit is related to scientific activities, detailing and advertising.
  • Cooperation with Global Regulatory, Global Medical Dept. and EU Medical team.
  • Ensure that the corresponding Global department is made aware of any relevant information or changes (such as labels and/or SmPC, new product license information or changes).
  • Regulatory activities in the Balkans region (RB medicinal products or products carried out in cooperation with foreign companies)
  • The lifecycle of medicinal products as per assigned brands: variations, Marketing Authorization renewals, labeling updates, artwork revision, and approval.
  • Verifies and approves documents which are prepared within the department and registration dossiers in the country or abroad
  • Verifies and approves the draft design for boxes, labels, foils, and leaflets
  • Verifies and approves applications for variations documentation both for products registered in the country, and those registered in the Balkan region
  • Verifies and prepares the submission dossiers for promotional materials for OTC products in accordance with the existing information from SmPC, current legislation

 

Requirements:

  • University Science degree in a relevant Scientific discipline (Chemical Engineering/ Chemistry/ Pharmacy/ Biochemistry).
  • Broad knowledge of regulatory and healthcare registration systems.
  • Minimum 1-year experience working within a laboratory environment or Regulatory/Medical Affairs.
  • Ability to understand and interpret directives and regulatory guidelines and communicate them effectively to the relevant stakeholders

 

Personal Attributes:

  • In line with Reckitt Benckiser core values, the associate will be achievement focused and able to work in a direct and often pressurized environment. Entrepreneurial skills in terms of innovation and problem solving are key along with tenacity, tough-mindedness and ability to influence and demonstrate strong team working abilities and commitment
  • Ability to work in an international environment
  • Result-oriented, entrepreneurial and self-motivating
  • Strong negotiating and interpersonal skills
  • Commercial understanding of operational business issues
  • Understanding of marketing strategy and planning issues
  • Ability to transform solid thinking into action
  • Openness to change and ability to think out of the box
  • Native: Romanian, Advanced: English

 

In return, RB offers very competitive salaries with excellent benefits and the chance to progress your career within a truly Global organization.

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