Abbott Regulatory Affairs Specialist in Moscow, Russia

Main responsibilities :

  • Responsibility for developing a comprehensive registration strategy in close cooperation with the personnel dealing with sales, operations, vaccines and marketing, taking into consideration Company's interests and normative requirements.

  • Responsibility for insuring earliest possible registration of all new or in-line products, claims, formulations and/or strengths, along with price registration/re-registration, shelf-life changes according to adopted registration strategies (and company's high ethical standards policy).

  • Reviewing registration files and all related documentation of the Company's products and preparing such documentation in line with local normative regulations.

  • Preparing Application Forms and other documentation for filing and registration of new products. Ensuring that all documentation, samples, commercial packs and other items are provided to relevant agencies as needed.

  • Establishing and maintaining good working relationships with all involved regulatory and other institutions. Keeping track of new normatine documents related to registration of medicines.

  • Cultivating best possible relations with local regulatory bodies and opinion leaders and enhancing the Company's image in the medical community in general.

  • Handling all issues related to changes in the Company's products status and performing regulatory related surveys in the country.

  • Preparing and reviewing package labels and inserts for Company's respective new and in-line products registered in the country.

Requirements :

  • Higher education

  • At least 2 years of experience in Regulatory Affairs (medical equipment, pharmaceuticals, chemical products)

  • Strong willing to develop in IVD regulatory affairs field;

  • English – written, spoken

  • Excelent knowledge of MS Office (Word, Excel)

  • Personality: team player, well organized, attentive to details, enthusiastic, quick learner

  • Ability to work with big amount of information

Benefits:

  • Medical insurance for the employee and his children (100% coverage);

  • Medical insurance for a spouse (50% coverage);

  • Life insurance (accidents)

  • Food allowances

  • Various training programs

  • Employee assistance programs

  • Compensation costs for fitness (for employees who have been with the company for over 1 year)

An Equal Opportunity Employer

Abbot welcomes and encourages diversity in our workforce.

We provide reasonable accommodation to qualified individuals with disabilities.

To request accommodation, please call 224-667-4913 or email corpjat@abbott.com