Regulatory Project Manager, New Registration CMC, CMC Excellence

Regulatory Project Manager, New Registration CMC, CMC Excellence

Within the CMC RA group, the New Registration CMC team bring together the operational and execution aspects for key regulatory deliverables such as new marketing applications, product expansion dossiers and CTA submissions. The New Registration CMC team provides regulatory support across small molecules, biopharm and vaccines products.

This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following…

• Independently assesses, manages, and/or drives the CMC submission  deliverables, coordinates, timely prepares and authors multiple complex CMC technical regulatory documents to support applications for clinical trials and marketing authorisation 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 various projects, and provide guidance to R&D teams, Quality Control, GSC, QA and LOC

• Ensures adequate interaction and partnership with Senior Stakeholders in order to define proper regulatory CMC filing strategy demonstrating flexible thinking and continuous improvement

• 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

• 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

• 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

Why you?

Basic Qualifications:

We are looking for professionals with these required skills to achieve our goals:

• 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

• 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 skills. High ability to manage matrix teams and direct multiple projects

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• 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

• 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

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

• Veeva Vault knowledge would be an asset

Why GSK?

At GSK we offer a wide range of additional benefits:

• Career at one of the leading global healthcare companies

• Hybrid work ( 2/3 days per week from the office)

• 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 counterparts.

• Sports cards (Multisport)

• Possibilities of development within the role and Company’s structure

• Personalized learning approach (internal trainings, mentoring, access to online training’ platforms

• Extensive support of work life balance (flexible working solutions, health & well-being activities)

• Supportive community and integration events

• Modern office with creative rooms, fresh fruits every day

#LI-GSK

#LI-HYBRID

The annual base salary in Poland for new hires in this position ranges from PLN 236,250 to PLN 393,750 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.

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 [email protected] 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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