ASEA
  • 11-Nov-2020 to 10-Jan-2021 (MST)
  • Europe
  • Munich, DEU
  • DOE
  • Salary
  • Full Time

REGULATORY SPECIALIST (EU)

 

ASEA is looking for a talented and enthusiastic Regulatory Specialist to join our team. ASEA, a global leader in cellular health, is dedicated to providing a sustainable lifestyle by delivering high-quality health products through a direct-selling distribution model.

 

 

SUMMARY:

 

This person will manage all technical and regulatory efforts, interact with internal and external parties, and support scheduling and general communication for the European region. The Regulatory specialist works as a partner with the European management team, regional based sciences and outside resources to manage product compliance, maintaining new and existing market notifications and discuss those with Headquarters. The ideal candidate will be teachable, energetic, organized, and can work under pressure. This position will answer to the corporate regulatory affairs management.

 

 

 

RESPONSIBILITIES:

 

  • Independently manage all daily operations of regulatory affairs.
  • Work on all matters regarding product compliance.
  • Resolve a broad range of regulatory, scientific, and technical issues concerning product legal application to government bodies and international counterparts.
  • Act as liaison with outside counsel and provide general oversight and organization of their assignments working with corporate and regional management.
  • Monitoring of product related regulatory trends and provide proactive support.
  • Work with local authorities and counsel around the region to determine regulatory consideration in specific situations.
  • Understand and support company Intellectual Property needs.
  • Keep abreast of practice standards and trends affecting the industry.
  • Provide regular task updates to legal, peers and executives.
  • Maintain legal records, files, and case management tracking.
  • Other duties as assigned.

 

 

 

QUALIFICATIONS: 

 

  • State examination degree (2. Staatsexamen) in food chemistry required.
  • Prior practical regulatory experience required.
  • Intellectual Property experience preferred.
  • of 3+ years of technical regulatory experience, preferably in the food industry.
  • Experience and strong understanding of EU regulations, laws, norms and standards applicable to Food Supplements and Cosmetic products.
  • High attention to detail and excellent judgment.
  • Able to format and construct various filings, correspondence, and other legal documents.
  • Strong interpersonal communication and organizational skills.
  • Able to work independently and prioritize in a dynamic, ever-changing environment.
  • Professional appearance and attitude required.
  • Understanding of industry regulatory issues, including advertising law, contract law, national product notification procedures and labeling for Food Supplements and Cosmetic, and its importation.
  • Very good English skills. Speaking another European language is advantageous.

 

 

BASIC FAMILIARITY INCLUDES:

 

  • Interpret Data: Ability to read, interpret and draw accurate conclusions from technical or regulatory materials.
  • Relationship Management: Ability to develop and maintain effective and productive relationships, including ability to influence, negotiate and manage conflicts effectively and constructively with international colleagues and from different departments, vendors and peers.
  • Critical Thinking: Ability to formulate conclusions and recommendations using facts and data, technical regulatory analysis, deductive reasoning and sound judgment.
  • Priority Management: Effectively oversees, coordinates, and integrates resources to support project and/or organizational goals; provides support and guidance to navigate the bureaucracy of the organization.
  • Planning and Organizing: Establishes courses of action for self and others to ensure work is completed efficiently and on time, on profile and on budget.
  • Issues Resolution: Uses sound judgment to escalate issues for quick resolution; allows for challenges to be alleviated with a sense of urgency.

 

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