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:
Min. 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.
What we offer
You will join a supportive and inclusive team where your voice matters. You will get development opportunities that match your ambitions. You will do work that contributes to meaningful outcomes for patients and communities.
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The annual base salary in Poland for new hires in this position ranges from PLN 144,750 to PLN 241,250 gross, taking into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and/or awards for exceptional performance (granted at the employer’s discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave. More detailed information on the total reward package applicable to your role will be supplied during the recruitment process. Salary ranges for other locations are shown because some markets have pay transparency laws that require salary information on job postings, and those locations are potential job sites for this role. If salary ranges are not displayed in the job posting for a specific location or country, the relevant compensation will be discussed during the recruitment process. Please note salaries vary by country based on the market rate for the role.As an Inclusive employer, we encourage you to reach out if you need any adjustments during the recruitment process. Please contact our Recruitment Team at pl.recruitment-adjustments@gsk.com to discuss your needs.
Why GSK?
Uniting science, technology and talent to get ahead of disease together.
GSK is a global biopharma company with a purpose to unite science, technology and talent to get ahead of disease together. We aim to positively impact the health of 2.5 billion people by the end of the decade, as a successful, growing company where people can thrive. We get ahead of disease by preventing and treating it with innovation in specialty medicines and vaccines. We focus on four therapeutic areas: respiratory, immunology and inflammation; oncology; HIV; and infectious diseases – to impact health at scale.
People and patients around the world count on the medicines and vaccines we make, so we’re committed to creating an environment where our people can thrive and focus on what matters most. Our culture of being ambitious for patients, accountable for impact and doing the right thing is the foundation for how, together, we deliver for patients, shareholders and our people.
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.
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