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.

Main purpose:

• Manage Regulatory Affairs activities for North and West Africa Region for Abbvie’s pharmaceutical product and medical devices portfolio
• Coordinate activities related to the assigned portfolio and medical devices across North West Africa region

Main Responsibilities

REGULATORY AFFAIRS

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

• Keep abreast of emerging legislation, local or international, related to registration of pharmaceutical products and medical devices, pharmacovigilance and matereovigilance and highlight the potential impact on the business
• Gather a thorough knowledge of the registration files of assigned company product documentation. Keep up to date on assigned products
• Provide Regulatory support in determining and implementing NWA strategy for the assigned portfolio
• Review registration packages prior to submission to ensure compliance with local and corporate requirements.
• Work with the demand and marketing departments for proper Business Case Form preparation.
• Ensure that all Regulatory submissions (new marketing authorisation applications, renewals, variations, notifications) are prepared and filed in a timely manner for assigned Company products marketed and/or registered or planned for registration in.
• Gain Regulatory Authority approval for marketing authorisations for new products.
• Maintain all existing product marketing authorisations and gain Regulatory Authority approval of variations (amendments) to these authorisations as required.
• Manage any further information requests from local Regulatory Authority in a timely manner, ensuring local authority’s expectations are accurately translated for AbbVie Area Regulatory. Submission of any subsequent responses/product documentation updates to local Regulatory Authority.
• Review Product Information in accordance with legal and regulatory requirements; ensure that all prescribing information is accurate, updated and approved by both Company and relevant Regulatory Authority in accordance with Company policies and local regulations.
• Work closely with logistics department to organize timely sample delivery
• Coordinate handling of company core date sheet (CCDS) updates for assigned products.
• Provide and/or manage translations as required
• Provide feedback and support on regulatory strategy and status on regular basis to affiliate and area stakeholder
• Work closely with Market Access team to ensure price submission and approval for all new and registered products for assigned portfolio in NWA
• Coordinate with Labeling specialist and supply regarding  implementation within agreed timeframe, including development with third parties of updated artwork for cartons, labels and leaflets in accordance with Company requirements and local regulations for all products.
• Review promotional materials per the approved labeling, applicable guidelines and local regulations, and within the required timeframe, educate the brand team on the promotion code when needed

Regulatory Excellence:

• Cooperate and liaise with manufacturing sites, corporate headoffice and other affiliate departments.
• Represent AbbVie in the relevant pharmaceutical trade associations for medical devices and liaise with external stakeholders, as appropriate.
• Establish and maintain good relationship with all involved regulatory institutions in NWA.
• Identify and track changes/trends in the authorisation practice and attitudes in NWA, especially when related to devices and communicate them within the Company.
• Interact with distributors; service providers and regulatory agencies to resolve related review questions.

Compliance/Training:

• Ensure compliance with AbbVie’s corporate policies, procedures and guidelines as well as with local regulations to meet statutory, quality and business requirements within the overall strategy and objectives of NWA Region.
• Be the support function within NWA for Regulatory training and other Regulatoryrelated activities.

Transforming the Organisation:

• Participate in local brand teams to assist with product development and project planning to ensure that the proposed development plans account for regulatory requirements and that clinical advice is available throughout the process.
• Develops and implements the regulatory affairs strategy that aligns with both business needs and global goals and vision and its current and longterm business objectives  for the assigned portfolio in  NWA. Ensures that all activities and programs are implemented in accordance with the organization's strategy.
• Support business development on the market.

People/Talent:

• Plans and coordinates with the brand team, mainly in Algeria and other related departments in NWA, outlining registration component needs and timing for assigned portfolio .
• Ensure Training of NWA stakeholders on relevant Regulatory process, focusing on medical devices

Qualifications

Background:

• Strong leadership and team work skills
• Minimum of 3 years experience in a regulatory position with Medica device responsibilities in healthcare industry
• Fluency in English both verbal and written, efficient Computer Skills.
• ability to work to tight deadlines
• Good knowledge of device regulation in North West Africa Markets
• Thorough attention to details and high standards of accuracy
• Significant knowledge of Local (and global (EU and US)) Regulatory Affairs requirements.
• Sound judgment, strong communication and negotiating skills

Education:

Education: University degree in Bachelor of Pharmacy or equivalent scientific diploma

 

 

Travel
No
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.