Regulatory Affairs Lead for Pharmaceutical Products

2 days ago

Athens, Attica, Greece beBeeRegulatoryAffairs Full time

We are seeking a highly skilled Regulatory Affairs Lead to oversee the compliance of our pharmaceutical products in the EU market. This role requires a strong understanding of regulatory strategies and documentation requirements, as well as excellent communication and project management skills.

Key Responsibilities
  • Develop and implement regulatory strategies to ensure compliance with EU regulations and guidelines.
  • Prepare and submit high-quality regulatory documents, including DCP, MRP, RUP, and National applications.
  • Liaise with external regulatory authorities and internal stakeholders to resolve any issues or concerns.
  • Maintain accurate and up-to-date records of regulatory submissions and correspondence.
  • Collaborate with cross-functional teams to ensure regulatory compliance throughout the product lifecycle.
Requirements
  • Bachelor's degree in Chemistry, Biology, or related field.
  • Minimum 2-4 years of experience in Regulatory Affairs within the pharmaceutical industry.
  • Fluent English language skills and proficiency in MS Office.
  • Strong organizational and time management skills, with ability to prioritize multiple tasks.
  • Excellent communication and interpersonal skills, with ability to build strong relationships with colleagues and stakeholders.
  • Knowledge of EU and global regulatory guidelines and frameworks.
Benefits

This role offers a competitive salary and benefits package, as well as opportunities for career development and growth. If you have a passion for regulatory affairs and a commitment to excellence, we encourage you to apply.

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