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Regulatory Compliance Manager

vor 3 Monaten


Munich, Bayern, Deutschland AL Solutions Vollzeit

Join the forefront of pharmaceutical advancement with AL Solutions

AL Solutions, a well-established family-owned pharmaceutical enterprise with a rich history spanning over five decades, is on the lookout for a talented (Associate) Manager of Regulatory Affairs to enhance their dynamic team.

About Us: We are not just another pharmaceutical entity; we are a medium-sized leader in the development and production of superior pharmaceutical products. Our success is driven by state-of-the-art technology and an unwavering commitment to excellence that has defined our legacy for years.

Your Role: As a pivotal member of our team, you will oversee our regulatory strategies, ensuring that our groundbreaking products are delivered to patients safely and effectively. Your responsibilities will include:

  • Formulating approval strategies for both national and international markets
  • Expertly navigating the intricate landscape of approval processes, renewals, and notifications
  • Collaborating with various departments to produce comprehensive regulatory documentation
  • Managing product lifecycles adeptly and addressing any deficiency notices
  • Acting as our regulatory representative with partners and authorities globally
  • Mastering eCTD submissions and electronic documentation
  • Ensuring that all product information remains precise and current

Who You Are:

  • A graduate in natural sciences with a strong interest in Drug Regulatory Affairs
  • An expert in regulatory guidelines and legal frameworks
  • Proficient in MS Office and electronic submission management tools
  • Fluent in English; proficiency in additional languages is a plus
  • An independent thinker with a structured approach and goal-oriented mindset
  • A skilled communicator with a proactive attitude
  • Quality-focused yet practical in finding effective solutions
  • A collaborative team player who excels in both team settings and independent tasks

What We Offer:

  • An opportunity to make a significant impact within an international organization
  • Compensation that reflects your outstanding contributions
  • Flexible working hours in a contemporary office environment
  • A collegial atmosphere where colleagues feel like friends
  • Stable employment with clear opportunities for advancement