Head of CRA Labeling
Mylan N.V.
Hatfield, Hertfordshire, UK
2d ago

For Us, It's A Mission At Mylan, we mean it when we say we work every day to provide access to high quality medicines to the world's 7 billion people.

If you are unconventional, relentless and passionate. If you believe in doing what's right, not what's easy. If you are a doer and have a passion for serving others, we want to talk to you.

Make a Difference At Mylan, each person has the ability to make a difference. From the providers who sell and market our products, to the producers who develop and manufacture them and finally to our business partners who support the providers and producers, we all have a mission critical role.

Here's how this role will help :

  • Lead CRA Labelling Teams across multiple locations. Set objectives, conduct mid-year and end-year reviews, and ensure training, development and coaching of team members in order that they meet the team and individual objectives
  • Ensure Product Information texts for procedures managed by CRA are prepared to a high standard and on-time according to agreed company procedures and objectives.
  • Support team members by reviewing texts intended for submission and advise Senior Management regarding any deficiencies or issues

  • Provide Subject Matter Expert support to Head of Labelling and Regional Support - Europe, CRA Labelling Teams, and other Stakeholders, with initiatives which impact, or may impact, Labelling activities within the region (including the National markets) to ensure that proposed, or on-
  • going, activities consider relevant Legislation and guidance etc.

  • Represent the CRA Labelling teams during internal or external inspections and audits
  • Convene regular Global Labelling Committee meetings, acting as Chair, making and implementing decisions affecting Labelling activities within the region Advise Head of Labelling and Regional Support -
  • Europe of the status and progress of department performance management and functional KPI’s, identifying potential problems or delays, and possible solutions, as they occur and maintain a status report for these activities

  • Ensure compliance of the CRA Labelling team to relevant SOPs and guidance documents etc
  • Maintain an awareness of regulatory requirements (including legislation, guidelines, industry best practice, and through liaison with competent Authorities).
  • Use this information to influence, change and optimise departmental procedures and processes

    Make Our Values Your Values

    Mylan hires only the best. People who thrive in a culture of innovation and empowerment. People who are active learners and have a positive attitude.

    People who are leaders and know that by working together we can run faster, reach higher and achieve more. By doing so, we will continue to set new standards in health care.

    Here are the minimum qualifications and essential functions for this position :

  • At least 15 years’ experience in the Pharmaceutical Industry preferably within a Regulatory, Product Safety and / or Labelling environment.
  • However, a combination of experience and / or education will be taken into consideration

  • Must have at least 5 years functional management experience
  • Minimum of a Bachelor of Science Degree
  • Must understand the requirements for the submission, approval and implementation of labelling and artwork for pharmaceutical product labelling throughout the EU region and have an awareness of the updates required throughout the product lifecycle
  • Strong organisation and communication skills with broad business awareness and the ability to interact at all levels of the organization
  • Must be able to review, interpret, and discuss governing regulations, precedent interpretations, and documentation
  • Must be adept at data analysis, pay keen attention to detail and possess a strong commitment to continuous improvement
  • Must be able to communicate complex concepts to all levels within the organization
  • Must be able to effectively present information to senior management and / or public groups
  • Why Mylan?

    If you want to be part of a global health care company that is making a difference and changing lives, Mylan may be the place for you.

    With a workforce of more than 35,000 worldwide, we can make a difference. We encourage you to visit Mylan.com to learn more about our unconventional culture, our approach to doing business and how we plan to set new standards in health care.

    Mylan offers competitive salary, excellent benefits and an environment conducive to professional growth and advancement.

    All qualified applicants will receive consideration for employment without regard to their disability or protected veteran status.

    Mylan is an Equal Opportunity Employer.

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