Regulatory Affairs Manager FAC
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Primary Function / Objective
Understand Key elements of the commercial organization and overall requirements and pathways with full operational knowledge about the regulatory drivers in the cluster.
Work with Regional regulatory Head to set appropriate regulatory Strategies on the short medium and long term by adding new products to our portfolio.
Major Responsibilities / Accountability
- Ability to provide regulatory strategic direction to internal and external stakeholders including team members,business leaders, distributors,health authorities and local industry associations.
- Put in place Cluster strategy considering local environment and regional/global guidelines.
- Proactively translate strategy into action, by anticipating,flagging concerns, risks and mitigating in partnership with local healthcare trands,analyses business impact,develop strategies,policies and actions to effectively address issues aligned with Abbott’s strategic goals and influence policu decisions for a favorable healthcare environment.
- Develop and manager affiliate’s registration and reimbursement strategies to obtain optimum reimbursement and new products including new indications and extensions.
- business and develop effective response strategies and action plan regarding accordingly to ensure business benefit.
- Reduce health economic barriers for prescribers and provide better access for patients by collaborating government affairs.
- Combine knowledge of scientific,regulatory and business issues to enable Abbott EPD/business activities to meet required legislation.
- Work in collaboration with Global/Area for the localization of the strategic initiatives.
- Assist in the development and/or management of regulatory strategy and update strategy based upon regulatory changes.
- Proactively assess trands, policies and emerging issues and develop strategies, policies and actions to effectively address issues that impact Abbott business operations.
- Supervises the country Regulatory Affairs heads in execution of regulatory activities (regulatory role in clinical trials; regulatory submissions; evaluation of product and manufacturing changes for regulatory implications; maintaining annual licenses, registrations, listings and patent information; review and approval oflabel changes and promotional items; oversight of systems related to product safety issues and product recalls, project management, etc.)
- Prepare Regulatory plans and ensure their implementation to achieve long-term objectives for products that can be quantified in terms of sales, market share and profit contribution goals.
- Work with GPRA for new product, renewal and variation dossiers preparation
- Timely execution of market access strategies by collaborating effectively with all internal (sales & marketing, medical and clinical) and external stakeholders
- Manage the affiliate's external affairs advocacy through working with key stakeholders in government and in industry associations.
- Following and implementing the decisions of the local authorities that have an influence according to the timelines defined.
- Actively participate to the meetings, arranged by Association of Research Based Pharmaceutical Companies (AIFD) and Pharmaceutical Manufacturers Association of Turkey (IEIS) regularly, and actively play role in shaping the regulations.
- Manage regulatory and registration activities involved in the drug development process and/or post-marketing lifecycle management including ability to manage complex regulatory projects
MARKET INTELLIGENCE & Business Development
- Work with business Development and Marketing to set appropriate regulatory strategies on the short, medium and long term by adding new products to our portfolio
- Provide regulatory input to product lifecycle planning and in all stages of product development.
- Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and work with appropriate teams to develop solutions.
- Identify emerging regulatory issues and analyze broad scope implications of changing regulations and guidance.
- Demonstrate leadership of influencing skills in a matrixed environment and people management across cultures and geographies. Maintain a balance between controlling and empowering team members with appropriate mentoring and coaching
- Develop appropriate succession planning to ensure ongoing development of key skill sets in order to minimize disruption to the company's business and ensure that all members of the group are motivated to contribute fully to the realization of the company's mission, vision, goals, and objectives.
- Ensure SFE and field force optimal activity by maintaining full staffed teams with motivated and qualified employees at all times.
- Evaluate and develop competencies in terms of product knowledge, action plan definition, activity monitoring and communication skills to physicians. Train Rep when necessary.
- Implement Performance Management process with Direct Reports (Perfomance Excellence, End-year assessment, bonuses, salary increases).
- Identify talents and propose specific Growth Plans.
- Identify Low Performers. Develop Performance Improvement Plans.
- a good working environment with focus on acquiring, developing and retaining top talent for the corporation.
- Maintain effective communication with the local representatives and MOH officials across the region by field visits.
- Work with the demand and marketing departments for proper Business Case Forms preparation
- As area label coordinator, work closely with different manufacturing sources, QA and label development department to get labels developed, approved and implemented as the time frame agreed with the management
- Develop and maintain relationship with key stakeholders, Government Departments and other payers in partnership with Government Affairs.
- Maintain and strengthen communication with key decision makers who plays critical role in health policy, pricing and reimbursement processes, opinion leaders
- Customize technical data into simple compelling messages in the format required and appropriate for local stakeholders
- Define Value Propositions by consolidating Core Value Dossiers, stakeholder needs, local environment and brand priorities
- Pursues for opportunities to conduct partnership projects (i.e. studies, initiatives)
- Work in coordination with regional and global teams to identify further requirements for value propositions development
- Monitor and influence external environment for impact on company products/business activities (e.g., regulation changes, government practices, trade association activities, etc.).
- Accountable for compliance with Regulatory SOPs and identification of improvement opportunities for SOPs.
- Ensure compliance with Corporate and Divisional Standard Operating Procedures SOPs, Good Clinical Practice, and local regulatory requirements pertaining to the conduct of clinical studies.
- Relay Abbott Corporate values - train new recruits
Key Success Factors
- Strong communication and influence skills with both internal and external stakeholders. Demonstrated ability to be assertive, persuasive, and decisive with stakeholders.
- Exceptional knowledge of local laws and regulations across FAC countries with a wide external networking and strong regulatory expertise liaison throughout product lifecycle.
- Demonstrate a collaboration to drive product plan development and implementation, regulatory strategy, risk management
- Expert knowledge of cluster/ region market access regulations and mechanism in order to derive expert insights to guide affiliate/cluster holistic access strategy
- Establishment of RA organization functional vision with innovative, sustainable strategies that anticipate, and influence regulatory environment shifts and meet company objectives.
- Translate strategies into specific goals and actions for the team. Build high-performing team that consistently deliver both individual and team goals.
- Expert knowledge of country/cluster market access regulations and mechanism in order to derive expert insights to guide affiliate/cluster holistic access strategy
- Degree in Pharmacy
- Minimum 5 years of relevant experience.
- Solid pharmaceutical experience, including significant regulatory & Market Access experience
- Communicate effectively verbally and in writing and with diverse audiences and personnel
- Ability to work and negotiate with various disciplines, organizations, and cultures.
- Good leadership capabilities
- Project management skills
- Fluent in Arabic, English and French
- Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
- Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal
in Algeria , Algeria city
number of positions
1 Jobs available, apply now