Manage Regulatory Affairs activities for Levant Region for Abbvie?s pharmaceutical product portfolio
Main ResponsibilitiesREGULATORY AFFAIRSAdvance Pipeline/Marketed Product Support: Submissions, Renewals & Approvals:
Keep abreast of emerging legislation, local or international, related to registration of pharmaceutical products and pharmacovigilance 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 LEVANT 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 Levant.
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
Co-ordinate 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 LEVANT
Be the local contact point for clinical trials across the Levant region and represent AbbVie with local authorities for submissions related to clinical trials
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
Support customer Excellence department and patient experience when it comes to submission of Patient Support Programs and lead potential interactions with Regulatory authorities in Levant, related to Patient Support programs
Regulatory Excellence:
Cooperate and liaise with manufacturing sites, corporate head-office and other affiliate departments.
Represent AbbVie in the relevant pharmaceutical trade associations and liaise with external stakeholders, as appropriate.
Establish and maintain good relationship with all involved regulatory institutions in LEVANT.
Identify and track changes/trends in the authorisation practice and attitudes in LEVANT, 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 LEVANT Region.
Be the support function within LEVANT for Regulatory training and other Regulatory-related activities.
Transforming the Organisation:
Participate in local brand teams for strategic portfolio 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 long-term business objectives for the assignedstrategic products portfolio in LEVANT. Ensures that all activities and programs are implemented in accordance with the organizations strategy.
Support business development on the market
People/Talent:
Plans and coordinates with the brand team, other related departments in LEVANT, outlining registration component needs and timing for assigned portfolio .
Ensure Training of LEVANT stakeholders on relevant Regulatory process
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 LEVANT Region.Accountability:This position reports to the Regulatory Affairs Director, LEVANTThe incumbent will be:
Accountable for the day to day management of Regulatory Affairs within LEVANT
Responsible for presentation and accuracy of documentation prepared and, where appropriate, submitted to the local Regulatory Authority.
A low level of supervision is anticipated along with project responsibility and interaction with senior managementQualifications:
University degree in Bachelor of Pharmacy
Strong leadership and teamwork skills
Minimum of 3 years experience in a regulatory position in healthcare industry
Fluency in English both verbal and written, efficient Computer Skills.
