Reg Submission Specialist, SDE-LCM

GSK•Brooklyn Center, MN

11d

About The Position

At GSK, we have bold ambitions for patients, aiming to positively impact the health of 2.5 billion people by the end of the decade. Our R&D focuses on discovering and delivering vaccines and medicines, combining our understanding of the immune system with cutting-edge technology to transform people’s lives. GSK fosters a culture ambitious for patients, accountable for impact, and committed to doing the right thing, making sure that we focus our efforts on accelerating significant assets that meet patients’ needs and have the highest probability of success. We’re uniting science, technology, and talent to get ahead of disease together. Find out more: Our approach to R&D Scope: The Regulatory Submission Specialist is responsible for supporting regulatory submission activities, including authoring, reviewing, providing Regulatory registration requirements and compiling dossiers for assigned deliverables in compliance with health authority regulations and GSK policies and processes. The position holder works with the Submission teams, Local Operating Company contacts, Global Regulatory Strategy or Functional Teams (or equivalent) to coordinate and prepare submission packages within the Veeva Vault system. The position holder will be supporting Global Regulatory teams in the preparation of regulatory dossiers for R&D and Commercial projects, ensuring submissions are delivered within agreed timelines and in compliance with GSK policies and processes.

Requirements

Bachelor’s degree or higher in biological or healthcare science.
1-3 years of relevant experience.
Basic understanding of the pharmaceutical industry, drug development processes, manufacturing, supply and R&D objectives.
Knowledge of EU and ROW regulations, guidelines, procedures, and policies for the registration and manufacturing of pharmaceutical and vaccine products. Ability to interpret and provide advice on submission guidelines and requirements, utilizing recent GSK experience.
Proficiency in using Veeva Vault systems or the ability to quickly learn and adapt to required technical skills.
Fluency in English and Arabic, and a level B2 in French.
Excellent organizational skills, meticulous attention to detail, and a strong commitment to producing high-quality work, even in challenging regulatory deadline environments.
Proven capability to manage workloads, prioritize effectively, adapt to shifting demands, and oversee multiple projects simultaneously.
Strong written and verbal communication skills, with the ability to deliver clear and concise information. Experienced in fostering effective relationships and collaborating efficiently within a matrix environment.
Strong service orientation with a commitment to delivering customer-focused solutions.
Skilled at leveraging internal and external information resources to identify and resolve unique, undocumented scenarios effectively.

Responsibilities

Under management oversight, responsible for delivering assigned submissions in line with the agreed dossier strategy to the Submission teams, Local Operating Company contacts, Global Regulatory Strategy or Functional Teams (or equivalent) by working collaboratively with functional teams (e.g., CMC, Clinical, Nonclinical, etc.) & ensuring adherence to established timelines.
Simultaneously, follow-up for multiple project assignments, including Variations (CMC and Therapeutic), PBRER, Renewals, Site Registrations/Site Renewals, Tenders of varying complexity.
Manage regulatory registration requirements, including those requested directly from regulatory agencies, manufacturing sites or third-party service providers. This includes providing manufacturing site support to meet regulatory expectations.
Prepare, coordinate and ensure timely delivery of documents requested from health authorities, legalization providers, manufacturing sites or third parties.
Accountable for adhering to GSK ways of working, processes and written standards, while building a thorough understanding to ensure right first-time delivery. Leverages regulatory intelligence resources to determine Regulatory registration requirements, ensuring they are fit for purpose for assigned submissions as needed, and proactively identifies risks associated with submission data and information packages.
Keep regular communication with the line manager, technical lead, functional teams and LOCs (or equivalent), and, where applicable, with health authorities and external stakeholders (certificates and samples). Implements the agreed dossier strategy for assigned deliverables and escalates any issues that could affect the business, such as unavailable deliverables or changes in local requirements.
Ensures the quality and compliance of both personal and team submissions with regulatory guidelines and processes, under management oversight. May review peers deliverables and propose improvements to regulatory processes, policies, and systems thereby driving efficiency & innovation.
Develops expertise in regulations, guidelines, procedures, and policies governing pharmaceutical product registration and manufacturing to facilitate efficient submission, review, and approval of global regulatory applications. Demonstrates adaptability and learning agility to navigate internal and external regulatory landscapes.
Demonstrates strong collaboration skills and the ability to build effective organizational networks, actively fostering and expanding connections within the organization.
Communicate effectively with internal and external GSK stakeholders on project- and policy-related matters with minimal managerial supervision, ensuring the best outcomes for the organization.