Regulatory Affairs Specialist for Active Pharmaceutical Ingredients
Job Area: R&D / Quality
Location: Bioiberica's facilities
To maintain and grow the API sales business by preparing, presenting and monitoring health authorities' evaluation and approval of Drug Master Files (DMF), dossiers or technical documentation corresponding to APIs developed and manufactured by Bioiberica.
Main Responsibilities:
* Ensure safety, quality, and efficacy of APIs through accurate DMFs/dossiers preparation.
* Submit DMFs/dossiers to relevant health authorities or customers, track their evaluation and approval process, and address related inquiries from Commercial Departments.
* Stay updated on regulations governing DMFs/dossiers and other regulatory competencies, applying them to maintain the regulatory status of final products containing intermediates or APIs with potential regulatory impact.
* Assess change controls affecting intermediates or APIs with regulatory implications and manage relevant changes or updates to registration dossiers with Authorities and clients.
* Participate in projects launching new APIs, advising teams on regulatory strategies enabling approval.
* Collaborate as needed in Public Administration procedures preparation.
* Review and approve advertising material created by the Marketing Department to ensure compliance with registered API and applicable regulations.
Requirements:
* 5 years of experience in Regulatory Affairs for Pharmaceutical registrations/DMF preparation.
* Bachelor's degree in Biology, Biochemistry, Chemistry, Pharmacy, or similar field.
* High-level English proficiency at technical writing level.