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Munich, Bayern, Deutschland Fricke Finance & Legal VollzeitJob DescriptionFricke Finance & Legal GbR is a family-owned company with over 15,000 employees and multiple locations worldwide. The company is a leading technology conglomerate that aims to create a secure and connected world. The position of Manager Financial Sanctions and Regulatory Compliance is a staff function within the Financial and Accounting...
Regulatory Compliance Manager
vor 3 Monaten
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