GlaxoSmithKline Pharmaceuticals Ltd. is looking for B.Pharma, M.Pharma candidates for the following posts. Please check the details to apply.
GlaxoSmithKline is one of the world’s leading pharmaceutical and healthcare companies, with statisticians and programmers working at UK and US R&D sites, and worldwide. In recognition of the developing sophistication and technical requirements of the programming role, the Clinical Programming department was formed as a standalone department within the broader Clinical Statistics group 18 months ago, covering all phases of clinical drug development and commercialization in a wide range of therapeutic areas.
People are at the heart of everything we do. We aim to bring differentiated, high-quality, and high-performing healthcare products to those who need them with our global businesses, scientific and technical know-how, and talented people.
Bringing innovative products and improving access to them is critical to helping build stronger, healthier communities. We leverage our legacy of over 90 years in India to help transform people’s health through our extensive product portfolio that includes prescription medicines and vaccines. We are the leaders in anti-infectives and dermatology in the pharmaceuticals industry and in vaccines too we are the leaders in the private segment.
Title: REGULATORY SPECIALIST, COUNTRY LABELLING
Qualification: B.Pharma, M.Pharma
Experience: 5 – 9 years
Salary: Not Disclosed
Skills: ROW PI, product labeling, Country PI, labeling Document, Country Labelling
Roles and Responsibilities
- Author and compile Regional/Country PI as per regulatory authority labeling requirements and GSK process and standards.
- Author and compile market-specific supporting documentation for labeling submissions in accordance with regulatory authority requirements and GSK process and standards.
- Provide support to global and local GRA team members through the preparation of other labeling documents as required
- Complete quality and consistency checks of labeling document content.
- Efficiently coordinate and manage labeling documentation and data in regulatory systems.
- Provide advice regarding regulatory authority labeling requirements and GSK labeling process and standards to GRA global/local roles and via Regulatory Matrix Teams.
- Effectively communicate with GSK staff (including GRA, Global safety and medical, and Local Operating Companies) to author, compile and deliver quality labeling documents. May communicate with Regulatory Agencies and third parties on behalf of GRA labeling staff.
- Support other regulatory functions and participate in other projects and activities as needed, such as leading the design and implementation of changes to labeling processes and evaluation of new agency labeling requirements.
- For some roles, may be required to perform translation of labeling text into identified languages.
- Subject Matter Expert in country/regional labeling content and process for markets with complex labeling requirements:
- provides coaching, mentoring, and knowledge sharing within GSK Labelling skill group
- completes quality checks for colleagues outputs
- effectively manages interactions with Senior Stakeholders
- takes accountability for the management of labeling deliverables for country/region, including delivery of high-quality outputs to timelines
- may represent GSK externally.
Desired Candidate Profile
- >5years relevant experience (in the pharmaceutical industry, life sciences research, or regulatory).
- Successfully performed within a regulated or quality-critical environment such as pharmaceutical industry research, pharmacy, safety, or regulatory).
- Attention to detail, significant experience in document and database management, excellent organization, and time management skills to handle multiple projects for different customers.
- Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner.
- Ability to think flexibly in order to meet constantly shifting priorities and timelines.
- Broad understanding of the pharmaceutical industry, drug development environment, development, and established product lifecycle maintenance and regulatory processes.
- Knowledge and understanding of product labeling (e.g. through direct exposure to the management of labeling documents/submissions/data; including label authoring).
- Experience in maintenance of labeling documents in multiple countries/regions including knowledge of label document content, process, and associated regulatory agency labeling requirements. Experience of more than 1 of the following regions/countries:
- EU PI annexes (including EU CP/MRP/DCP procedures)
- US PIs
- Canadian Monographs
- ROW PIs
- Experience in authoring and/or updating Labelling SOPs, WIs, QRGs by identifying areas for efficiencies in existing Labelling processes
- Proficient with computer software applications
- Familiarity with medical terminology required
- Ability to lead problem-solving and negotiate solutions to complex labeling issues.