Regulatory Affairs Director North West Africa

Abbvie - الجزائر - Algiers

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 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 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 authorizations and gain Regulatory Authority approval of variations (amendments) to these authorizations as required. 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. 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. Submit any subsequent responses/product documentation updates to local Regulatory Authority. 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. 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. 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: Identify and track changes/trends in the authorisation practice and attitudes in NWA and communicate them within the Company to monitor and forecast regulatory environment as needed. 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. 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 Regulatoryrelated 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 longterm 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 coordinate 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. Qualifications Background: Minimum of Ten (10) years of experience in a multinational NWA pharmaceutical environment with a strong experience in the Algerian Market and understanding of global (EU and US)) Regulatory Affairs requirements. Strong leadership skills. 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. Strong communication and negotiating skills, 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. Education: Education: University degree in Bachelor of Pharmacy Travel No Job Type Experienced Schedule Full-time Job Level Code M 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.

تاريخ النشر: ٢٢ سبتمبر ٢٠٢١
الناشر: Bayt
تاريخ النشر: ٢٢ سبتمبر ٢٠٢١
الناشر: Bayt