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Regulatory Affairs Manager, North West Africa - Algiers

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Location: Hydra, Alger, Algeria

Summary:

  • Manage Regulatory Affairs activities for NWA for assigned AbbVie’s product portfolio and Represent RA AbbVie on all Brand Teams to ensure all existing and new products comply with government standards and business priorities;
  • Represent RA AbbVie in front of distributors, Trade associations and local government bodies (when applicable);
  • Manage the FWA Regulatory team (1 direct report RA specialist).

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, drive the regulatory strategy in line with business priorities after aligning with NWA RA Director and ensure the implementation;
  • Drive the regulatory strategy for assigned portfolio within ATC and support the implementation;
  • Keep and establish smooth relationships with local distributors and regulatory agency for regulatory affairs, including registration, renewal, variations, pricing, vigilance, and inspection-licensing for effective and timely market all products;
  • Provide guidance on the approval processes to marketing colleagues in the and regulatory input for launch planning;
  • Work with Global and local teams thus ensuring local needs are considered in Global/Regional regulatory strategies which support the strategic planning process, local inputs to dossier development and product owner for pharmaceutical products;
  • Support the registration of complex applications, including but not limited to new products in accordance with relevant legislation and guidelines so that appropriate patient and business outcomes are achieved;
  • Contribute to broader operational, strategic discussions with brand team and area that impact the business;
  • Gather a thorough knowledge of the registration files and all related company product documentation. Keep up to date on Company products;
  • Provide Regulatory support in defining and implementing NWA RA strategy within the assigned portfolio;
  • Work with the demand and marketing departments for proper Business Case Form preparation;
  • Review and sign-off registration packages prior to submission to ensure compliance with local and corporate requirements;
  • Ensure that all Regulatory submissions (new marketing authorisation applications, renewals, variations, notifications) are prepared and filed in a timely manner for Company products marketed and/or registered in NWA or new products intended to be marketed Follow up all steps for authorisation/approval of these submissions;
  • 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;
  • 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 with Labelling packaging projects strategy and 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;
  • Co-ordinate handling of company core date sheet (CCDS) updates for all products;
  • Keep accurate records of all health authority correspondence as well as key internal communications and review promotional material foe compliance with relevant laws, guidelines, codes of conduct and policies;
  • Review and approve local promotional material from regulatory perspective;
  • 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 FWA 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 Morocco and FWA Region;
  • Be the support function within Morocco 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 FWA 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 FWA 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, Business Country Lead, Morocco Brand teams, Area and Global RA

External Stakeholders:

Government Regulatory Authorities, Distributors

Requirements:

  • Education: University degree in Bachelor of Pharmacy;
  • Strong leadership and management skills;
  • Minimum of 5 years of experience in a multinational Morocco, Algeria and FWA pharmaceutical environment with a strong experience in the Moroccan/ Algerian Markets and understanding global (EU and US)) Regulatory Affairs requirements;
  • Ability to think strategically in all aspects of incumbent’s 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 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 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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