Senior Regulatory Specialist, New Registration CMC

7 miesięcy temu

Poznań, Polska 9605 GSK Services Sp z o.o. Pełny etat

What we are doing?

Global Regulatory Centres (GRC) in GSK are regulatory affairs functions which bring together the operation and execution aspects for key regulatory deliverables such as new chemical entity and product expansion dossiers, labelling outputs, licence maintenance and lifecycle management dossiers, and regulatory information management. The Global Regulatory Centres provide regulatory support across the product lifecycle for pharmaceutical, biopharm and vaccines products (clinical development to market maturity).

New Registration CMC Team (Chemistry, Manufacturing, and Controls) is part of GRC and 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. When the science is our main area we also work with technology to perform at our best as we operates in a fast-paced and evolving environment.

Your Responsibilities:

Managing multiple CMC new files and CTA assignments for Pharma, Biopharm and Vaccines products including response to questions from Agency;

Define and agree regulatory strategy, complete data assessment to ensure CMC dossier is authored in compliance with Company regulatory processes and external requirements;

Working with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time;

Monitoring regulatory intelligence and act proactively on identified changes to regulatory requirements;

Effective communication also in a digital context, including virtual meetings and digital platforms;

Act as subject matter expert in regulatory processes;

Evaluating and implementing innovative solutions for CMC Regulatory processes, policies and systems;

Supporting digital transformation through active participation in building digital skills;

Why you?

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

Extensive experience in regulatory affairs, pharmaceutical industry (familiarity with CMC regulatory procedures and ICH CTD documentation)

Bachelor’s or Master’s degree in biotechnology, pharmacy, chemistry or other related science or technical field

Attention to details, excellent organization and time management skills

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.

Understanding of the pharmaceutical industry, drug development environment and regulatory processes.

Adaptability and Learning: A commitment to ongoing professional development with proven ability to learn and apply new concepts

Mindset that embraces digital transformation and innovation by being adaptable, forward-thinking, and eager to explore new possibilities in the ever-evolving digital landscape

Veeva Vault knowledge would be an asset

Why GSK?

We also offer a wide range of additional benefits:

Performance with Choice – flexibility in working mode (hybrid between office and remote work based on employee needs), flexible working hours, possibility of working from abroad up to 30 days a year

Established job in an international, well-known biopharma company

Opportunity to work in professional team playing important role in introducing and GSK portfolio on the markets

Wide range of benefits (Medical Plan, Life Insurance, Employee Retirement Program, Sport and recreation cards, Recreation allowance, annual bonus)

Recognition awards for additional achievements

Supportive & friendly working environment with integration events

Possibilities of development within the role and company’s structure with personalized learning approach (mentoring, coaching, online training’ platforms)

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

Modern office with creative rooms, fresh fruits every day

Free car and bike parking, locker rooms and showers.

#LI-GSK

#LI-Hybrid

Why 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/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class.

Important notice to Employment businesses/ Agencies

GSK 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.

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