Regulatory Manager

About Abbott

At Abbott, you can engage in meaningful work, foster your professional growth, and maintain a healthy work-life balance. We are committed to creating an environment where you can be your authentic self and live a fulfilling life. You will benefit from career development opportunities within a global corporation, recognition as a Great Place to Work in numerous countries, and acknowledgment as one of the world's most admired companies by Fortune. Abbott is also celebrated as one of the best large companies to work for, excelling in diversity, and supporting working mothers, female executives, and scientists.

The Opportunity

This role is based at our UAE location within the Established Pharmaceutical Division.

About Established Pharmaceuticals

Our mission is to extend the reach of our trusted medicines to more individuals in the world's most rapidly expanding markets. We offer a comprehensive selection of high-quality, differentiated branded generic medications spanning various therapeutic areas, including gastroenterology, women's health, cardiometabolic conditions, pain management/central nervous system disorders, and respiratory illnesses.

Job Responsibilities

• Oversee and manage regulatory activities and strategic plans for designated countries, including renewals, new registrations, variation changes, safety matters, pricing, labeling, and site transfers.
• Prepare and compile submission dossiers in strict accordance with country-specific regulatory requirements and guidelines.
• Manage diverse country-specific regulatory demands and tasks related to pharmaceutical products, ensuring alignment and coordination of all regional regulatory and registration needs.
• Provide essential regulatory support for tender-related business opportunities.
• Address and respond to inquiries from health authorities, coordinating the development of comprehensive answers.
• Initiate and manage pricing documentation tailored to the specific requirements of each country.
• Develop and produce updated product labeling in compliance with local regulations for core products, ensuring continuity of supply.
• Communicate revised patient information leaflets to relevant stakeholders.
• Review and submit promotional materials to health authorities in countries where such approvals are mandated.
• Engage with health authorities throughout the entire product lifecycle.
• Ensure the meticulous assembly of registration files, including all necessary documentation for expedited submission and approval processes.
• Offer expert guidance and support to colleagues and external partners.
• Coordinate regulatory organizational processes with various partners across different countries.
• Maintain effective communication channels with all business partners and internal teams.
• Manage and resolve queries from health authorities.
• Actively participate in various country-specific Regulatory Affairs networks to contribute to and establish a unified industry regulatory voice.
• Serve as the regulatory representative on project teams, offering expert advice on specific projects and contributing to the formulation of project plans and target product profiles.
• Support, back up, resolve issues, challenge, negotiate, plan, and maintain global and country-specific regulations and information.
• Facilitate communication and provide best-practice services to both internal and external partners.
• Challenge health authorities and regulatory bodies regarding variation tools and legislation.
• Identify optimal methods for information dissemination and enhance communication flows between all departments and functions.

Strategic Planning

• Assess the regulatory risks associated with corporate policies.
• Provide strategic direction for product development and lifecycle planning.
• Analyze and compare regulatory outcomes against initial product concepts, recommending future strategies and actions.
• Develop and update global regulatory strategies in response to evolving regulatory landscapes.
• Apply technical regulatory expertise to propose solutions for complex challenges.
• Monitor the positions of trade associations for their potential impact on company products.
• Proactively identify and address potential regulatory obstacles and emerging issues throughout the product lifecycle, collaborating with regulatory and related teams to devise solutions.
• Participate in relevant trade association and industry working groups to influence policy and rulemaking in alignment with business objectives.
• Ensure adherence to all applicable Corporate and Divisional Policies and Procedures.

Compliance

• Identify emerging regulatory trends and analyze the broader implications of regulatory changes and guidance.
• Take accountability for compliance with Regulatory Standard Operating Procedures (SOPs) and identify opportunities for SOP enhancement.

Training & Translation

• Be qualified to deliver training on local procedures.
• Be authorized to perform Arabic to English and English to Arabic translations.

Additional Information

This role requires a Bachelor's degree and 8-10 years of relevant experience in a similar capacity within the pharmaceutical industry, specifically based in the UAE. 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.