About AbbVie
AbbVie’s mission is to discover and deliver innovative medicines 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, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

REGULATORY AFFAIRS

Advance Pipeline/Marketed Product Support: Submissions, Renewals & Approvals:

• Monitore local regulatory requirements and communicates within AbbVie. Keep abreast of emerging legislation and highlight the potential impact on the business.
• Liaise with European Regulatory Affairs and Corporate groups on regulatory matters.
• Liaise with national regulatory authorities as required.
• Prepare and file of regulatory submissions in a timely manner. Follow up all steps for authorisation/approval of these submissions. Coordinates all those regulatory activities in Estonia & Latvia.
• Manage maintenance of existing pharmaceutical product marketing authorisations in Baltics.
• Ensure that all local product information (PI) and related documents submitted to local National Regulatory Authorities are uploaded to appropriate Systems and databases.
• Prepare SmPCs, PILs and labeling in accordance with legal and regulatory requirements.
• Support in Company Core Data Sheet (CCDS) update handling.
• Provide and manage required translation support.
• Review/approve of marketing materials of assigned products (medicines & medical devices) in Lithuania.
• Collaborate with Demand manager in order to implement the updated artworks (NP/MRP/mature CP products) in a timely manner.
• Lead for labelling procedure for Baltic countries and coordinates all labelling activities for EE & LV for appropriate products (medicines & medical devices).
• Create, proofread and approve of Lithuanian labelling text, mockups, artworks and PILs.
• Work closely with Label centers to get labels developed, approved and implemented as per the required timeframe.
• Work with the affiliate brand teams (or act as backup) to provide regulatory information and timelines on affiliate  products.
• Provide Launch Excellence Tool support as applicable.
• Regulatory databases management.
• Archiving and record management of Regulatory documentation.
• Providing QC check for Regulatory documents, translations for Lithuania.
• Assist with immediate notification of any regulatory requests, including safety labelling changies, urgent safety restriction requests, as well as external inspections.
• Manage communication of regulatory submissions and approvals via the AbbVie Connect processes as well as changies in product information.
• Assist with monthly reporting: Summary of all Regulatory Activities.
• Support communications to local Commercial and Medical personnel relating to SmPC/PIL changes prior to their implementation.
• Manage payments of regulatory fees.
• Take ownership for management of the Rewards and Recognition process when appropriate.
• Comply with AbbVie ethical standards, policies and procedures.
• Achieve deadlines.
• Manage all required regulatory activities for CTA submission to SMCA in Lithuania.

Compliance/Training:

• Keep the assigned regulatory databases on Shared disc (server) up to date.
• Ensure compliance with statutory local, regional, EU and AbbVie corporate regulations.
• Use Total Talent as the tool for personal and position development.
• Responsible for execution of the training and education.
• Execution of the training and education outlined in the Development Plan.
• Comply with AbbVie ethical standards, policies and procedures.

Regulatory Excellence:

• Cooperate and liaise with manufacturing sites, corporate headoffice and other affiliate departments.
• Establish and maintain good relationship with all involved regulatory institutions in Lithuania.
• Coordinate and ensure effectiveness of Regulatory Affairs function in Baltics.
• Identify and track changes/trends in the authorisation practice and attitudes in the Baltics and communicate them within AbbVie.

 

Transforming the Organization: FutureFit/LRP:

• Support business development on the market.
• Coordinate activities that assist product areas by providing support for:
  • Sales and Marketing
  • Demand and planning

People/Talent:

Assist with training of AFFILIATE staff on relevant Regulatory processes.

General Responsibility:

-             To comply with the company’s policies and procedures to meet statutory, quality and business requirements within the overall strategy and objectives of AbbVie.

Qualifications

Background:

• Creative selfstarter capable of working autonomously and developing this role.
• Good problemsolving skills and the ability to work to tight deadlines.
• Effective project management and communications skills, someone who can engage and negotiate with multiple and varied project contributors.
• Highly developed project management skills, ability to work crossfunctionally and excellent coordination skills.
• Strong administrative skills, excellent communication skills.
• Good knowledge of registration requirements for medicinal products and medical devices in Baltic countries.
• Thorough attention to detail and high standards of accuracy.
• Previous experience of working in a similar position in a multi-national pharmaceutical company preferred.
• Proficiency in written/verbal local and English language.
• IT conversant.

Education:

• University degree (preferable Life Sciences) and several years’ experience in regulatory affairs specialist role.

*** Only short-listed candidates will be notified***

Travel
Yes, 15 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.