Regulatory Affairs Director

You'll be in charge of supervising and performing regulatory affairs tasks Pharmaceutical industry - Regulatory Affairs - Advanced English You'll be working with an international pharmaceutical company, well known in the industry. With more than 100 years of experience in the market. Deeply concerned about health issues and its coworkers. Compile the corresponding dossiers for registration, variation or renewal of pharmaceutical products in line with regulatory plans, acting as key contact point between our company and local sources. To submit high quality dossiers according to regulatory plans to Sanitary Authority and obtain necessary approvals as planned. Maintains very close communication and relationship with Corporate Regulatory team, Licensing companies, local subject matters etc, sending messages by mail, call, phone or video or organizing / attending to meetings with involved people. To obtain information and documents to compile and complete dossiers in time and/or to send / explain local regulatory requirements that must be complied. Contact point to Sanitary and related authorities in regarding dossier submissions by requesting and assisting to technical appointments necessary for submissions to ensure submission and approval in time for registration variation or renewal for the company's products in line with planned dates. Prepare reports with periodic RA/RI reports with professional impact analysis and share with stakeholders by monitoring and collecting all regulatory intelligence information and maintain regulatory status of the products updated, to give up to date input to stakeholders on actual portfolio regulatory status and on regulatory requirements. Give expertise in regulatory professional topics. Share relevant information, give professional opinion, make action points, draw up alternative solutions, find and contact local experts, to ensure deliveries on time to avoid authorities' questions Pharmacist (QFB or QFI) Advanced English Advanced sanitary legislation and related laws, norms and regulations. 3 years of experience as Regulatory Affairs Manager or 3 years of experience as Regulatory Affairs Chief or Supervisor or 3 years of experience as Manufacture, Documentation, Quality Assurance or Regulatory Affairs Pharmacist If you meet the requirements, apply to the job here. MXN120,000 - MXN160,000 por mes (MXN1,440,000 - MXN1,920,000 per year) MXN80,000 - MXN81,000 por mes (MXN960,000 - MXN972,000 per year) J-18808-Ljbffr J-18808-Ljbffr