Regulatory Affairs Senior Specialist with significant experience in the pharmaceutical industry, including roles in Competent Authority and multinational organizations. Demonstrated success in developing and implementing regulatory strategies for branded and generic drugs, OTC products, medical devices, and food supplements. Strong ability to collaborate across departments to ensure compliance with marketing and sales policies while adhering to regulatory and medical standards. Currently serves as Senior Regulatory Affairs Manager at Teva Portugal, managing multiple product categories and leading local regulatory affairs and market access initiatives.
Regulatory affairs professional with career focus on ensuring compliance and managing regulatory submissions within pharmaceutical industry. Skilled in navigating complex regulations and building strong relationships with regulatory authorities, leading to successful product approvals and market entries. Expertise in risk management and strategic planning drives consistent regulatory compliance and business growth.
Direct backup of Regulatory Affairs Director, ensuring seamless operations.
Reported to Medical Direction while overseeing internal coordination of regulatory affairs team.
Managed a team of three, ensuring effective communication with Global Team.