Oferta pracy

Regulatory Specialist (Annual Reporting, Site Registration and GMP Team)

GSKO firmie

GSK

Adgar Wave

Warszawa

Regulatory Platform Centres are creating new roles in the Annual Reporting, Site Registration and GMP Team, who will be responsible for the preparation and delivery of all regulatory submissions required in support of Annual Reporting (US and Brazil); Site Registrations and site Good Manufacturing Practice (GMP) certification for GSK’s established product portfolio for both Pharma (Rx) and Vaccine (Vx) products.

As we are in the process of establishing our new organization, we are looking for several candidates to join our Team.

In this role you will have an opportunity to interact closely across our global regulatory network in order to deliver CMC Annual Reports for New Drug Applications (NDAs), Biologic License Applications (BLAs), Drug Master Files (DMFs), Development Safety Update Reports (DSURs), Brazil CMC Annual Reports, Site Registrations and GMP submission, preparing technical documentation and providing regulatory expertise for GSK’s Pharma and Vaccine products portfolio.

If you are self-motivated, seeking next challenge and satisfaction knowing your efforts are making a difference in someone’s life, then this opportunity is for you.

Regulatory Specialist (Annual Reporting, Site Registration and GMP Team)Numer ref.: 277271

KEY RESPONSIBILITIES

In your new role you will:

  • take responsibility for planning, preparation, technical review, delivery and associated regulatory activities of CMC Annual Reports (for NDAs/BLAs/DMFs/DSURs and Brazil ARs), Site Registrations and GMP submissions for GSK’s established product portfolio for both Pharma (Rx) and Vaccine (Vx) products,
  • work closely and provide CMC regulatory advice and guidance to CMCRA, Pharma Supply Chain (PSC), Local Operating Companies and Regions in order to produce high quality and timely documentation in support of Annual Reporting, Site Registration and GMP certification,
  • participate in the creation, improving and implementation of working practices and procedures aimed at simplifying processes and increasing quality,
  • monitor regulatory intelligence and act proactively on identified changes to regulatory requirements,
  • manage multiple projects/products simultaneously,
  • build and maintain good relationships with your internal and external stakeholders,
  • may have training and mentoring responsibilities.

Requirements:

  • relevant experience in pharmaceutical industry and regulatory affairs,
  • bachelor’s degree in chemistry, pharmacy or other related science or technical field,
  • previous experience with eCTD/CTD documentation is preferred,
  • fluent Polish and English (both verbal and written),
  • ability to handle multiple tasks to prioritize and schedule work to meet business needs,
  • flexible and analytical thinking to independently provide solutions to issues,
  • detail-oriented, with emphasis on accuracy and completeness,
  • excellent interpersonal skills; ability to communicate, work in a diverse team environment and build relationships across a large organization.
  • understanding of the pharmaceutical industry, drug development environment, and regulatory processes.

We offer:

  • Established job in international, well-known pharmaceutical company
  • Opportunity to work in professional team playing crucial role in introducing GSK portfolio to the market
  • Opportunity to work within GSK standards and documentation applied globally
  • Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance)
  • Annual bonus
  • Canteen for employees at site (with discounts)
  • Flexible working hours
  • Remote work.
 

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