Senior Regulatory Specialist, New Registration CMC

1 dzień temu

Poznań, Greater Poland 9605 GSK Services Sp z o.o. Pełny etat
Job Title: Senior Regulatory Specialist, New Registration CMC

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.

Key Responsibilities:
  • Manage 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;
  • Work with colleagues in Global Manufacturing & Supply and GSK Local Operating Companies in markets worldwide to deliver high quality dossier on time;
  • Monitor 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;
  • Evaluate and implement innovative solutions for CMC Regulatory processes, policies and systems;
  • Support digital transformation through active participation in building digital skills;
Requirements:
  • 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 offer a wide range of additional benefits, including:

  • 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

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.

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.

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.

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