REGULATORY AFFAIRS SPECIALIST

For our client AbbVie, we are looking for an experienced and motivated professional to take on the challenging role of:

REGULATORY AFFAIRS SPECIALIST

AbbVie is a global biopharmaceutical company on a mission to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. AbbVie aim to address complex health issues and enhance people's lives across several key therapeutic areas – immunology, oncology, neuroscience, eye care, aesthetics and other areas of unmet need.

The Major Responsibilities Include:

• Support preparation and filing of regulatory submissions in a timely manner for company products marketed and/or registered in Bulgaria or new products intended to be marketed in Bulgaria. Follow up all steps for authorization/approval of these submissions.
• Support maintenance of existing pharmaceutical product marketing authorisations and monitor regulatory authority approval for the variations of these authorisations.
• Monitor local regulatory requirements and their communication within the company. Keep abreast of emerging legislation and highlight the potential impact on the business.
• Liaise with European and Global Regulatory Affairs on regulatory matters.
• Liaise with national regulatory authorities as required.
• Comply with the company’s policies and procedures to assure consistency of the current local prescribing information with the CCDS to ensure alignment within the organization/implement approved label though approved artwork process.
• Manage development of the Bulgarian artworks via relevant internal systems, including the update of relevant databases. Liaise with labelling centres, cooperate with international graphic vendors in creating the artworks, database management.
• Preparation/translation of Bulgarian language versions of SmPCs, PILs and labelling in accordance with legal and regulatory requirements.
• Manage uploading of product information (PI) and related documents into internal regulatory databases.
• Support the Head of Regulatory Affairs in all administrative matters related to RA department.
• Work closely with local Marketing/Medical departments to review and approve promotional/non-promotional materials for assigned medicinal products and medical devices.
• Manage payments of regulatory fees.
• Manage internal communications to local Marketing, Sales and Medical personnel relating to SmPC/PIL updates.
• Assist with immediate notification of any regulatory requests, including safety labelling changes, urgent safety restriction requests, as well as external inspections.
• Assist RA Director in execution of regulatory responsibilities regarding the affiliate vision and strategy aimed at influencing legal/healthcare policies and political developments.
• Identify and track trends in the authorisation practice and attitudes in Bulgaria and communicate them within AbbVie.
• Participate in local brand teams to assist with product development and project planning to ensure that the proposed development plans account for regulatory requirements throughout the process

Experience required:

• At least 2 years of experience in pharma regulatory affairs
• Experience in a multi-national pharmaceutical company is preferred

Qualification and skills:

• University degree, major in life-sciences could be an advantage.
• Good knowledge of local and EU legislative requirements regarding medicinal products and medical devices.
• Strong project management and administrative skills with thorough attention to detail and high standards of accuracy.
• Computer skills – MS Office, Adobe Pro, regulatory systems
• Fluency in English

Personal Characteristics:

• Problem-solving skills and the ability to work to tight deadlines.
• Ability to thrive in a changing environment and to re-prioritize workload to meet business needs.
• Excellent communications skills.
• Team player with ability to work cross functionally.

Лиценз № 2418 от 18.12.2017г