Job was saved successfully.
Job was removed from Saved Jobs.

Job Details


GlaxoSmithKline (GSK)

Senior Regulatory Specialist (339810)

Pharmaceuticals

All

Yearly

No

Warsaw, Indiana, United States

Site Name: Warsaw, Poznan
Posted Date: Jul 4 2022

Global Regulatory Centers 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, Canada, Brazil, China) and Sites/Facilities changes 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 and China CMC Annual Reports, Canadian Annual Notifications, Site/Facilities changes submissions, 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.

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, Canadian Annual Notifications, Brazil and China ARs), Site/Facilities variations 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 and Site/Facilities variations,
  • 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,
  • training and mentoring responsibilities,
  • act as SME, increasing capability within the team.

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 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
  • Flexible working hours
  • HYBRID working mode ( 1 day in the office per week)

*LI-GSK

*LI-HYBRID

If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-[Register to View] (US Toll Free) or +1 [Register to View] (outside US).

GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting [Register to View] site.