Regulatory Project Manager, New Registration CMC, CMC Excellence

Business Introduction

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   Position Summary Drives strategy for CMC regulatory submissions. Coordinates timely preparation and authors CMC complex technical regulatory dossiers to support applications for marketing authorisation, lifecycle activities and maintenance of registered pharma and vaccines products in accordance with the applicable regulations and scientific standards.

Identifies risks associated with submission data and information packages. Ensures adequate contribution and leads CMC Regulatory discussions during interactions with regulatory authorities Worldwide. 

Contributes to the creation, maintenance and continuous improvement of CMC Regulatory processes, policies, instructions, and systems.

Will serve as a mentor/trainer for new team members.

Acts as Subject Matter Expert.

Acts as Technical Dossier Approver.

Ensures adequate interaction and partnership with the Global Regulatory Lead’s team, GSC, QA, LOCs, ESQ in order to define proper regulatory CMC filing strategy.

  Responsibilities Independently assesses, manages, and/or drives the CMC strategy, coordinates, timely prepares, and authors multiple complex CMC technical regulatory documents to support applications for marketing authorisation, lifecycle activities and maintenance of registered products across Rx, Bx and Vx portfolios in accordance with the applicable regulatory and scientific standards, taking into account the evolving regulatory requirements.

Understands internal and external Regulatory environment with the ability to participate in corporate evaluation and provide CMC regulatory support and advice to in-licensing and divestment projects, and provide guidance to R&D teams, Quality Control, GSC, QA and LOC. 

Ensures adequate interaction and partnership with Senior Stakeholders (Leadership Team) in order to define proper regulatory CMC filing strategy demonstrating flexible thinking and continuous improvement while maintaining customer focus.

Ensures adequate contribution during interactions with Worldwide Regulatory Authorities.  Authors responses to Regulatory Agency questions.

Understands regulations, guidelines, procedures, and policies relating to registration and manufacturing of pharmaceutical products to expedite submission, review and approval of global applications while ensuring regulatory compliance is maintained and sharing best-practices and learnings within the CMC Regulatory teams and other impacted functions.  May engage and lead CMC Subject Matter Expert activities.

Mentors and/or trains staff, Develop Subject matter experts (SMEs) within team by providing guidance and relevant knowledge.

Identifies risks associated with submission data and information packages and can influence people, systems, processes, and formulate alternative approaches.

Contributes to, and leads (as required) the creation, maintenance and continuous improvement of CMC Regulatory processes, work instructions, policies and systems.  Ensures information submitted in marketing applications meets CMC and regional requirements and escalates to line manager, as applicable, risk or issues that have business impact.

Communicates, through the appropriate teams, complex regulatory issues across GSK and with external agencies and third parties as necessary to influence CMC project and   policy issues that are aligned with GSK business needs ensuring optimum position for GSK. May represent GSK externally (e.g. Audits, Conferences, External Forums).

Independently manages the completion of data assessment, ensures all appropriate CMC regulatory aspects, serves as dossier approver, identifies improvement opportunities, and confidently executes a dossier that is fit for purpose per agreed dossier strategy and timelines.

  Job-Related Experience Sound knowledge and understanding of drug development and manufacturing and supply processes and may have a specialized area of expertise.

Demonstrated ability to handle complex global CMC submissions and issues through continuous change and improvement.

Detailed working knowledge of complex worldwide CMC regulatory requirements and demonstrated ability to influence the global internal/external regulatory environment.

Proven project management and multi-tasking skills.

High ability to manage matrix teams and direct multiple projects.

Experience in influencing and negotiating with GSK personnel in a variety of settings.

  Other Job-Related Skills/Background Successfully performed within a regulated or quality-critical environment such as pharmaceutical industry research or regulatory.

Significant experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs.

Identified as CMC Regulatory expert in a specific subject area.

Highly developed interpersonal, presentation, and communication skills with established internal and external networks.

Proven experience in supervising and training staff within an organization.

Continued personal professional growth in global Regulatory Affairs with appropriate support from line manager.  Has broadened own knowledge base across Regulatory functions to understand wider implications of emerging issues across projects.

Attention to detail, excellent organization, time management and multi-tasking skills to handle multiple projects for different customers.

Excellent written and verbal communication skills and ability to present information in a clear and concise manner.

Service oriented and customer focused.

Clear and effective verbal and written communication skills in the English language.

  Basic Qualification Bachelor’s degree

Life Sciences or Medical Sciences

Working in complex environment within a scientific organization.

PhD/Master’s degree or above in Pharmacy, Biotechnology, Biology, Chemistry or closely related science advanced degree.

Significant experience in Pharmaceutical industry or Research organizations, established in Regulatory Affairs.

Project Management skills.

The ability to understand the scientific content of CMC technical documentation.

Skills Project Management, Regulatory CMC     Polish Salary Range / Polski przedział wynagrodzenia: PLN 236,250 to PLN 393,750The annual gross base salary range for new hires in this position is listed above for each applicable location. These ranges take into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. In addition, this position may offer an annual bonus and eligibility to participate in our share based long term incentive program which is dependent on the level of the role. More detailed information on the total benefits package will be supplied during the recruitment process. This role is available for applicants from multiple locations, and therefore salary ranges for certain locations are also shown. 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 candidate’s skills, experience, education level and the market rate for the role. Offers are typically made within the advertised range based on the candidate’s skills, experience and qualifications, with the upper end generally reserved for highly experienced candidates or other exceptional circumstances aligned with these criteria. 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.

Inclusion at GSK: As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment-adjustments@gsk.com to discuss your needs.

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