CMC Variations Regulatory Manager

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.
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Our approach to R&D


Position Summary:

• Managing direct reports.

• Ensures efficient delivery and high quality of Rx and/or Vx CMC projects (including technical content as well as Market Specific Requirements (MSRs)).

• Ensures effective regulatory processes are followed to assess and assure the quality, reliability and consistency of all data used in regulatory submissions.

• Defines and implements objectives for the team members to ensure business continuity and to address development needs.

• Drives continues improvement for defined and new processes.

Key Responsibilities:

• Manage HR aspects for a team of direct reports including effective recruitment, training and development.

• Efficiently plan, prepare and deliver of CMC projects in support of GSK’s established product portfolio for both Rx and/or Vx products.

• Provide quality check support as requested and able.

• Serve as point of escalation for team members and stakeholders.

• Recognize matters that affect corporate or agency policies and escalates issues with high business impact or risk.

• Participate in quality and continuous process improvement activities related to area of responsibility or as requested.

• Work efficiently in partnership with CMC RA, PSC and LOCs to ensure smooth delivery of CMC projects.  

• Understand regulations, guidelines, procedures and policies relating to registration and manufacturing of pharmaceutical products/registration data management/submission format to expedite submission, review and approval of global applications.

• Build CMC competencies in team and coach the team when needed.

• Track, analyze and report on team performance against key performance indicators.

This role is hybrid. You will be expected to work from either our Poznan or Warsaw office 2 days per week.
 

 Basic Qualifications & Skills:

• Around 5 years of experience in Regulatory Affairs in CMC area or related responsibilities for Rx and Vx of which 2+ years managing teams delivering CMC outputs

• Experience with managing a small team that successfully delivered outputs to time and quality over a sustained period

• Worked within a global organization across different geographical locations

• Successfully performed within a regulated or quality-critical environment

• Direct or indirect experience of regulatory processes associated with gaining and maintaining product registrations for both Investigational and Licensed Products

• Successful and sustained delivery of a significant number of CMC packages including a broad range of submission types across EU/US and International markets.

• English speaker, preferably with fluent Polish language skills

Why is this Level of Experience Required?

Must be able to lead team to deliver consistently within a technically complex and highly regulated environment within a global organization. This position will involve supervision of staff and therefore some experience of this is preferred.

Skills

Communication, Digital Fluency, Influencing Without Authority, Learning Agility, Pharmaceutical Regulatory Compliance, Problem Solving, Regulatory Strategies, Strategic Leadership

 

 

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.Roczny przedział wynagrodzenia zasadniczego brutto dla nowo zatrudnionych osób na tym stanowisku został wskazany powyżej dla każdej właściwej lokalizacji. Przedziały te uwzględniają szereg czynników, w tym umiejętności kandydata, doświadczenie, poziom wykształcenia oraz rynkowy poziom wynagrodzenia dla tego stanowiska W zależności od stanowiska i obowiązujących polityk wewnętrznych, rola ta może również uprawniać do otrzymania premii (jeśli ma zastosowanie i jest przyznawana na podstawie określonych, obiektywnych kryteriów) oraz/lub nagród za wyjątkowe wyniki (przyznawanych według uznania pracodawcy). Wszystkie świadczenia ustawowe będą zapewnione zgodnie z przepisami prawa polskiego. Mogą być także oferowane dodatkowe benefity, takie jak prywatna opieka medyczna, dodatkowe płatne dni wolne, ubezpieczenie na życie, prywatny plan emerytalny oraz w pełni płatny urlop rodzicielski i urlop na opiekę nad członkiem rodziny. Bardziej szczegółowe informacje na temat całkowitego pakietu wynagrodzenia i świadczeń przypisanego do tego stanowiska zostaną przekazane podczas procesu rekrutacyjnego. Przedziały wynagrodzenia dla innych krajów mogą być również widoczne, ponieważ na niektórych rynkach obowiązują przepisy dotyczące jawności wynagrodzeń, które wymagają zamieszczania takich informacji w ogłoszeniach o pracę, a wskazane lokalizacje mogą stanowić potencjalne miejsce wykonywania tej roli. Jeśli przedział wynagrodzenia nie jest podany w ogłoszeniu dla konkretnej lokalizacji lub kraju, odpowiednie informacje o wynagrodzeniu zostaną omówione w trakcie procesu rekrutacyjnego. Prosimy pamiętać, że poziom wynagrodzenia różni się w zależności od kraju i jest ustalany na podstawie umiejętności, doświadczenia, poziomu wykształcenia oraz rynkowego poziomu wynagrodzenia dla danego stanowiska. Oferty są zazwyczaj przedstawiane w granicach wskazanego przedziału, z uwzględnieniem umiejętności, doświadczenia i kwalifikacji kandydata, przy czym górna granica jest zwykle zarezerwowana dla kandydatów o bardzo dużym doświadczeniu lub w innych wyjątkowych okolicznościach zgodnych z tymi kryteriami.

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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