Regulatory Manager, Delivery, CMC Small Molecules Mature Products

Poznań, wielkopolskie
Stała
Pełny etat

29 dni temu

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.Are you ready to make a meaningful impact on global healthcare? As a Regulatory Manager, Product Variations Delivery, CMC Small Molecules Mature Products you’ll lead a team responsible for delivering high-quality regulatory dossiers that ensure the continuity of supply for essential medicines. This role offers the chance to collaborate with diverse stakeholders, drive process improvements, and contribute to patient care worldwide. We value candidates who are proactive, detail-oriented, and passionate about leadership and regulatory excellence.Key Responsibilities:

Lead and develop a team to create a motivating and efficient work environment.
Plan and ensure timely delivery of high-quality regulatory submissions for European and global markets.
Act as a quality control point, ensuring submissions meet high standards and regulatory requirements.
Identify risks to project timelines or quality, resolve issues, and escalate when necessary.
Drive continuous process improvements to enhance efficiency and effectiveness.
Build and maintain strong relationships with internal and external stakeholders.
Monitor, analyze, and report team performance against departmental goals.

Basic Qualifications:

Bachelor’s degree in a scientific or technical field.
Relevant experience in regulatory affairs (pharmaceutical industry), with familiarity in post-approval Chemistry, Manufacturing, and Controls (CMC) regulatory procedures and ICH CTD documentation (Modules 2 and 3)
Proven ability to lead, motivate, and develop a team.
Fluent in English and Polish (spoken and written).
Excellent interpersonal and communication skills.
Ability to manage multiple tasks and prioritize effectively to meet deadlines.
Adaptability to changing circumstances and a disciplined, logical work style.

Preferred Qualifications:

Master’s degree in a scientific or technical field (life sciences, pharmacy, biotechnology, chemistry).
Leadership experience with a focus on team development and change management.
Strong problem-solving and negotiation skills.
Practical knowledge of risk management principles.
Project management experience is a plus.

Benefits:

Career at one of the leading global healthcare companies
Attractive reward package (competitive salary, annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit
Possibilities of development within the role and company’s structure
Life insurance and pension plan
Open and inclusive environment which is supportive and welcoming of all diversity strands (gender, race, ethnicity, sexuality, disability, or any other characteristic)
Private medical package with additional preventive healthcare services for employees and their eligible counterparts
Sports cards (Multisport)
Personalized learning approach

Extensive support of work life balance (flexible working solutions including working from home possibilities, health & wellbeing activities)
Supportive community and integration events
Modern office with creative rooms, fresh fruits everyday
Free car and bike parking, locker rooms and showers

#LI-GSKG7Why 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/ AgenciesGSK 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

GlaxoSmithKline

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