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Team Lead Global Regulatory Affairs Strategy(m/w/x)

AOP Health
Wien
ab 90.000 / Jahr

You lead a regulatory team, ensuring compliance and managing product submissions. Your role includes overseeing budgets, coordinating with stakeholders, and maintaining quality management systems while keeping up with regulatory developments.

Anforderungen

  • •University degree in natural sciences.
  • •Minimum 5 years of regulatory experience.
  • •Proven ability to lead a small team.
  • •Experience coordinating regulatory submissions.
  • •Strong sense of responsibility and attention to detail.
  • •Skilled in managing internal and external stakeholders.
  • •Excellent written and spoken English skills.

Deine Aufgaben

  • •Manage and develop direct reports in the regulatory team.
  • •Act as regulatory lead for assigned products.
  • •Coordinate submissions and ensure compliance with regulations.
  • •Supervise preparation of marketing authorization dossiers.
  • •Lead lifecycle management of authorized products.
  • •Handle deficiency letters and change requests.
  • •Drive regulatory planning and align timelines.
  • •Maintain oversight of the regulatory quality management system.
  • •Coordinate with internal departments and external partners.
  • •Oversee regulatory budget planning and invoice tracking.
  • •Stay updated through training and regulatory events.
  • •Administer Lorenz DocuBridge for document management.

Deine Vorteile

Personal responsibility and creativity
Open corporate culture
Motivated international team
Opportunities for development
Excellent work environment
Competitive salary package
Minimum gross annual salary
Bonus
Home office
Company car
Employee mobile phone
Flexible working hours
Laptop
Initial and continuing education
Canteen
Good transport connection
Employee events
Meal allowance
Company doctor
Parking spot
Health measures
Employee discount

Original Beschreibung

Team Lead Global Regulatory Affairs Strategy (f/m/d) ==================================================== | 1190 Wien | Vollzeit | Start: as of now | **In this role, you will lead a regulatory affairs team and oversee strategy, submissions, and compliance for assigned products. Combining team leadership with hands-on regulatory expertise, you’ll ensure timely, high-quality submissions and effective lifecycle management across key therapeutic areas.** What Your Day To Day Will Look Like * Manage, support, and develop direct reports within the regulatory team, setting objectives and evaluating performance. * Act as regulatory lead for assigned products, coordinating submissions and ensuring compliance with EU and non-EU regulatory frameworks. * Supervise the preparation and maintenance of marketing authorization dossiers in collaboration with R&D and internal stakeholders. * Lead the lifecycle management of authorized products, including handling deficiency letters and change requests. * Drive regulatory planning and ensure alignment with internal and external timelines and expectations. * Maintain oversight of the regulatory quality management system (SOPs, work instructions, and departmental processes). * Coordinate with internal departments and external partners (e.g., RA consultants) on submission-related matters. * Oversee regulatory budget planning, invoice tracking, and consultancy fee processing. * Stay updated through continuous training and participation in external regulatory events. * Act as the administrator for Lorenz DocuBridge software for document and submission management. Your **Qualifications and Experience** * University degree in natural sciences or equivalent. * Minimum 5 years of regulatory experience with solid knowledge of EU regulatory frameworks and lifecycle management. * Proven ability or potential to lead a small team with strong organizational and decision-making skills. * Experience coordinating regulatory submissions and communicating with authorities. * Strong sense of responsibility, attention to detail, and ability to work independently. * Skilled in working cross-functionally and managing both internal and external stakeholders. * Excellent written and spoken English communication skills. Our Offer * A position with personal responsibility and space for creativity * Open corporate culture with the opportunity to bring in your own ideas * Highly motivated, agile, and international team * Great opportunities for personal and professional development * Attractive work environment with excellent career opportunities and flat hierarchies * Competitive salary package plus bonus, various benefits * Gross annual salary for this function is a minimum of EUR 90.000.- based on full-time employment (38.5 hours/week). Any potential overpayment depends on professional experience and qualifications. Main Benefits * Bonus * Homeoffice * Flexible working hours * Initial and continuing education * Canteen * Employee events * Meal allowance * Company doctor * Parking spot * Healthmeasures
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