Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

Manages the Regulatory Affairs activities within AbbVie Romania for all AbbVie pharmaceutical products.

Support for products under development and for marketed products: deposits, reauthorizations, variations and related activities.

Provides support to the Market Access department to obtain all the information and documents necessary for the price approval file in the shortest possible time for all new/strategic products in Romania.

Ensure compliance with company policies, procedures and guidelines, as well as local and European regulations to meet regulatory, quality and business requirements within AbbVie's global strategy and dealership objectives.

It acts as a support function within the affiliate to carry out trainings and other specific Regulatory activities when appropriate.

Collaborate and connect with manufacturers, AbbVie headquarters, and other affiliate-level departments.

Represents AbbVie in the Relevant Pharmaceutical Associations (ARPIM) and liaises with stakeholders in the absence of a Regulatory Affairs Manager when they receive this request.

Establishes and maintains a good relationship with all institutions involved in regulatory activity in Romania.

Identifies and tracks changes/trends in practices, attitudes and the legislative framework in the authorization of pharmaceutical products and communicates these changes/trends within the company.

Provides support for the Launch Excellence process at affiliate level (Romania), if required.

Provides training for AbbVie Romania staff in relevant Regulatory processes.

It is a component part of the quality assurance team for external audits and inspections by regulatory authorities.

Qualifications

- Previous experience of at least 2 years in Regulatory Affairs, in a company in the health industry.

- Significant knowledge related to Regulatory procedures and legislation, national and European.

- Solid skills in analysis, communication and negotiation

- Excellent collaboration skills in a team.

- Developed project management skills.

- In-depth knowledge of English (written and oral), IT skills.

- University studies in Pharmacy

- Higher professional qualification in a scientific or business discipline, desirable.

Additional Information

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

https://www.abbvie.com/join-us/reasonable-accommodations.html