Manager Regulatory Affairs, Europe and Emerging Markets

Abbott Laboratories (NoordHolland, Nederland) 4 dagen geleden gepost
Full-time

About Abbott

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

About Abbott Established Pharmaceuticals

We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.

What will you do as a Manager Regulatory Affairs?

As Manager Regulatory Affairs, your primary job consists of 5 core tasks.

Product registrations /Submissions

  • Proactively Identifies/obtains data needed, and ensures that they are effectively presented for the registration of products

  • Assesses scientific data provided by specialist units for registration purposes against regulatoy requirements

  • Defines regulatory strategies to ensure RPT submissions and competitive speed to market approvals

  • Manages the preparation of registration packages and answers to deficiency letters

  • Ensures records of filings and approvals are maintained according to internal and external standards and requirements and throughout product lifecycle

  • Approves the complete regulatory data packages prior to filing and during the approval process

  • Prepares agency meeting packages, and develops strategies for agency meetings

Relationships & Cross Functional teamwork

  • Represents Regulatory Affairs at relevant meetings, e.g., Product Workstream, CMC Workstream, presents agreed RA position and negotiates with and influences management (Manufacturing, Quality, Development, Commercial etc.) to ensure programs meet regulatory requirements and business needs  Plans and ensures execution according to planned activities and timelines.

  • Identify, resolves and / or escalate issues impacting project progression for resolution and mitigation

  • Participates in agency meetings as appropriate

  • Trains, develops and mentors individuals

  • Maintains proactive awareness of regulatory legislation and assesses its global impact on business and product portfolio

Affiliate Coordination

  • Maintains working relationships with defined countries and provides support

  • Aligns on regulatoy commitments, milestones and objectives / priorities translated into regulatory strategies (regulatory strategy plans and updates)

Strategy

  • Facilitates policy development and standard interpretation of regulations

  • Provide regulatory expertise to licensing departments

Process Improvement

  • Identifies and implements process improvements

  • Identifies opportunities for business and efficiency improvements

What kind of knowledge and experience do you bring with you?

  • You have a Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject  A relevant master's degree is preferred

  • You have 7 years of work experience within the field; ideally includes 3 years in Regulatory  You have a practical and pragmatic attitude;

  • You are critical and pro-active in your actions:

  • You have good analytical skills;

  • You are strong in commination and like to work in a team;

  • You master the Dutch language and English language in speaking and writing.

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.

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Manager Regulatory Affairs, Europe and Emerging Markets

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