Senior Regulatory Specialist, CMC Renewals

Renewals CMC Team (Chemistry, Manufacturing, and Controls) plays a crucial role in ensuring that Pharma and Vaccines products are safe, effective, and of high quality for patient use. Team is responsible for authoring, compiling, and checking regulatory submissions related to drug manufacturing and quality control. While the science is our main area we are also working with technology to perform at our best as we operate in a fast-paced and evolving environment.

Key Responsibilities:

• Independently manages multiple CMC (Chemistry, Manufacturing and Control) renewals assignments for Pharma and Vaccines products including response to questions from Agency; assignments will range in complexity but more complex work is expected.
• Independently and confidently defines and agrees on regulatory strategy, completes data assessment to ensure CMC dossier is authored in compliance with Company regulatory processes and external requirements for international markets
• Identifies risks associated with submission data and information packages
• Escalates issues with line manager that have business impact, suggesting possible solutions
• Understands regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products, to expedite submission, review and approval of global applications.
• Identifies improvement opportunities for regulatory processes, policies and systems.
• Serves as dossier reviewer (peer review and/or quality check)
• Provides consultation and solutions being the subject matter expert in specific areas of expertise. Acts as mentor/trainer for new staff.
• Effectively communicates also in a digital context, including virtual meetings and digital platforms
• Works with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time
• Understands internal/external regulatory environment.
• Monitors regulatory intelligence and acts proactively on identified changes to regulatory requirements
• Supports digital transformation through active participation in building digital skills
  

Why You?

Basic qualifications:

• Bachelor's degree in Life Sciences, Chemistry, Health Sciences, or related fields
• Min. 3 years of relevant experience in regulatory affairs, pharmaceutical industry (familiarity with post-approval CMC regulatory procedures and ICH CTD documentation is required)
• Understanding of the pharmaceutical industry, drug development environment, and regulatory processes.
• 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.
• Mindset that embraces digital transformation and innovation through adaptability, forward-thinking, and exploring new possibilities in the ever-evolving digital landscape
• Good team worker, ready to lead initiatives when needed (project management skills would be an asset)
• Excellent interpersonal skills; communication and influencing skills with the ability to work in a diverse environment and build relationships across a large organization
• Excellent time management skills to handle multiple assignments, prioritize and schedule work to meet business needs
• Detail-oriented, with emphasis on accuracy, completeness and consistency
• Agile and analytical thinking to independently provide solutions to issues or propose process/ways of working changes
• Adaptability and Learning: A commitment to ongoing professional development with proven ability to learn and apply new concepts
• Veeva Vault knowledge would be an asset
  

Benefits:

• Career at one of the leading global healthcare companies
• Contract of employment
• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)
• Life insurance and pension plan
• Private medical package with additional preventive healthcare services for employees and their eligible
• Sports cards (Multisport)
• Possibilities of development within the role and company’s structure
• Personalized learning approach
• Extensive support of work life balance
• Supportive community and integration events
• Modern office with creative rooms, fresh fruits everyday
• Free car and bike parking, locker rooms and showers.

#LI-GSK
G8

Why GSK?

Uniting science, technology and talent to get ahead of disease together.

GSK is a global biopharma company with a special purpose – to unite science, technology and talent to get ahead of disease together – so we can positively impact the health of billions of people and deliver stronger, more sustainable shareholder returns – as an organisation where people can thrive. We prevent and treat disease with vaccines, specialty and general medicines. We focus on the science of the immune system and the use of new platform and data technologies, investing in four core therapeutic areas (infectious diseases, HIV, respiratory/ immunology and oncology).

Our success absolutely depends on our people. While getting ahead of disease together is about our ambition for patients and shareholders, it’s also about making GSK a place where people can thrive. We want GSK to be a place where people feel inspired, encouraged and challenged to be the best they can be. A place where they can be themselves – feeling welcome, valued, and included. Where they can keep growing and look after their wellbeing. So, if you share our ambition, join us at this exciting moment in our journey to get Ahead Together.

GSK is an Equal Opportunity Employer. This ensures that all qualified applicants will receive equal consideration for employment without regard to race, color, religion, sex (including pregnancy, gender identity, and sexual orientation), parental status, national origin, age, disability, genetic information (including family medical history), military service or any basis prohibited under federal, state or local law.

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 the Centers for Medicare and Medicaid Services (CMS) website at https://openpaymentsdata.cms.gov/