Regulatory Affairs Specialist

hace 1 semana

Guadalajara, Guadalajara, España Chemo A tiempo completo

Established in the pharmaceutical and healthcare sector for over 40 years, Chemo is a world-renowned leader in R&D and manufacturing. Our team of experts specialises in the research, development, manufacture, and marketing of active pharmaceutical ingredients and medicines for human and veterinary use.

About Us

We are committed to equal opportunities and treatment between men and women, as stated in the current legislation. We do not discriminate against any person on grounds of ethnicity, religion, age, sex, nationality, marital status, affective or sexual orientation, gender identity or expression, disability, or any other personal or social circumstance.

Job Description

We are seeking a highly skilled Regulatory Affairs Specialist to join our team. As a key member of our regulatory team, you will be responsible for compiling and managing registration dossiers and coordinating with Marketing Authorization Holders and Post Marketing Teams to ensure timely submission and approval of products.

Key Responsibilities:

  • To stay updated on changes in legislation and regulations and advise on potential impacts to product registration, marketing, manufacturing, or development.
  • To advise the R&D team on regulatory requirements for registration dossiers.
  • Compilation of required information for registration dossiers.
  • Registration submission and follow-up with Health Authorities and Licensees until product approval and launch.
  • Collaboration with the Port Marketing Team to achieve the objective of launching new products.
  • Coordination and preparation of answers to deficiencies letters received from Health Authorities.
  • Maintenance of regulatory files/database and chronologies in good order.
  • Establishment and maintenance of a system for tracking changes in documents submitted to agencies or licensees.
  • Technical support to the sales department with technical requirements of customers.
  • Serving as a regulatory liaison throughout the product lifecycle.
  • Serving as a regulatory representative to marketing, R&D teams, and regulatory agencies.

Requirements:

We are looking for a highly qualified individual with a degree in Pharmacy, Chemistry, or Biology. A Master's degree is an asset. Fluency in Spanish and English is mandatory, with knowledge of other languages being an advantage. At least 3-6 years of experience in the same function is required. Very good knowledge of general pharmaceutical legislation and regulations, including GMP, and expertise in ICH guidelines and registration dossier CTD format content are essential.

Estimated Salary: $60,000 - $80,000 per year

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