Regulatory Affairs Director NWA based in Algiers

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.

Main purpose:

• Manage Regulatory Affairs activities for North and West Africa Region for Abbvie’s product portfolio and Represent RA Abbvie on the NWA Regulatory team to ensure all existing and new products comply with government standards.
• Manage the North West Africa Regulatory Team

Main Responsibilities

Regulatory Affairs

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

• Keep abreast of emerging legislation, local or international, related to registration and pharmacovigilance and highlight the potential impact on the business;
• Develop, lead and drive the NWA regulatory strategy in line with business priorities and support the implementation across the NWA team.
• 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 authorizations as required.
• To work with Government Regulatory officials and their Think- Tanks to provide them with scientific materials or information on up to date international standards or regulatory trends
• Gather a thorough knowledge of the registration files of assigned company product documentation. Keep up to date on assigned products
• 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 in NWA or new products intended to be marketed in NWA Region. Follow up all steps for authorisation/approval of these submissions.
• Provide updates on status of NWA Regulatory strategy to Area and Region/Global including AMT members at major forums (Bex, Area & Affiliates) and support NWA team in providing updates to local BTs .
• 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.
• Review promotional materials per the approved labeling, applicable guidelines and local regulations, and within the required timeframe
• Work closely with internal stakeholders:
  • logistics department to organize timely sample delivery
  • the demand and marketing departments for proper Business Case Form preparation and coordinate with Area to get endorsement
  • Market Access team to ensure price submission and approval for all new and registered products in NWA
  • Labelling to supervise packaging projects strategy and implementation within agreed timeframe, including development with third parties of updated artworks for cartons, labels and leaflets in accordance with company requirement and local regulations

Regulatory Excellence:

• Represent AbbVie in the relevant pharmaceutical trade associations and liaise with external stakeholders, as appropriate.
• Represent the organization in matters before regulatory, legislative, or industry standards agencies so the organization’s interests are advanced.
• 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 and communicate them within the Company in order to monitor and forecast regulatory environment as needed.
• Oversee the most difficult, complex, or large application processes so the application has higher chances to be successful.
• Ensure the effectiveness of Regulatory Affairs function in NWA.
• Support NPI/Launch Excellence process in NWA

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 Regulatory-related activities.
• Has accountability for the function in NWA and provides the highest level of advice and recommendations on company regulatory compliance.

Transforming the Organisation:

• Participate in local brand teams to assist with new product development and strategic 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 long-term business objectives in NWA. Ensures that all activities and programs are implemented in accordance with the organization's strategy.
• Support business development on the market.
• Coordinate activities that assist product areas by providing support to all required functions
• Monitor regulatory developments in NWA and advise appropriate stakeholders on the potential impact of regulations on the organization.

People/Talent:

• Lead, Supervise and co-ordinate activities of direct report(s) in NWA ensuring that a strategic direction is provided and that team members have specific goals packages in place and that they are reviewed formally once per year and informally on a quarterly basis
• Ensure Training of NWA staff on relevant Regulatory process
• Develop a team of professionals to ensure the organization's regulatory affairs activities are conducted accurately, ethically, and according to relevant regulations, laws, and standards.

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 NWA Region.

Internal Stakeholders :

Brand Team, MKA, GM, AMT, RA Regional team, Area and Global RA, …

External Stakeholders:

Government Regulatory Authorities, Distributors in NWA

Educational Background:

University degree in Bachelor of Pharmacy

Additional Qualifications:

• Strong leadership and management skills.
• Minimum of Ten (10) years of experience in a multinational NWA pharmaceutical environment with a strong experience in the Algerian Market and understanding global (EU and US)) Regulatory Affairs requirements.
• Ability to think strategically in all aspects of incumbents areas of responsibility. Able to see the big picture and how tasks fit into the overall business and /or product strategy.
• Able to negotiate and collaborate effectively/ good team player and to work in a cross functional matrix environment.
• Able to identify and anticipate trends in NWA Regulatory affairs environment and to lobby on behalf of AbbVIe in influencing regulatory policy and outcomes.
• Fluency in English both verbal and written, efficient Computer Skills.
• Thorough attention to details and high standards of accuracy.
• Sound judgment, strong communication and negotiating skills.

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.

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