Head of Regulatory Submissions - Europe
Mylan N.V.
Hatfield, Hertfordshire, UK
3d 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 :

  • Provide leadership to the EU Central Regulatory Affairs (CRA) Submissions Teams, to obtain and maintain branded and generic marketing authorisations for products in designated EU and non-EU territories (through internal and 3rd Party / Business Development workstreams).
  • Ensure on-time launches, continued supply, and compliance for all products.

  • Support the Head of Regulatory Affairs - Europe by providing input on regulatory status of products in various lifecycle states : development, submission, approval and post-approval.
  • Perform any other regulatory activities as required to support company strategy.

  • Lead EU Central Regulatory Affairs (CRA) Submissions Teams across different EU locations responsible for obtaining and maintaining Marketing Authorisations
  • Lead and track Key Products to ensure regulatory milestones are achieved on-time. Be accountable for EU Central Regulatory Affairs (CRA) Submissions Teams, ensuring agreed project commitments and timelines are met;
  • and provide regulatory status of key products in various lifecycle states : development, submission, approval and post-approval.

    Ensure Line Manager is kept aware of potential problems or delays for escalation, and provide possible solutions.

  • Represent EU Central Regulatory Affairs (CRA) Submissions Teams on Key Project meetings, to include Portfolio Review and Senior Leadership meetings;
  • provide regulatory guidance based on current expertise / knowledge and use this to influence decisions / outcomes.

  • Drive submission quality through review and implementation of improvements to Module 1 / regional aspects to reduce validation timelines;
  • and Module 2-5 by promoting and facilitating active feedback to Regulatory Science teams to reduce approval timelines.

    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 :

  • Scientific degree
  • Proven experience and tenures working in pharma regulatory affairs for established products
  • Proven and recent experience in managing and leading EU submissions
  • People management experience
  • Ability and desire to work in a smaller, fast paced pharma environment
  • 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, Minorities / Female / Disabled / Veteran.

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