Regulatory Project Manager

4 tygodni temu

Warszawa, Mazovia, Polska 9605 GSK Services Sp z o.o. Pełny etat
Job Title: Regulatory Project Manager

We are seeking a highly skilled Regulatory Project Manager to join our team at GSK. As a key member of our regulatory affairs team, you will be responsible for ensuring the development and execution of regulatory strategies for assigned assets, while maintaining compliance with internal processes and regulatory requirements.

Key Responsibilities:
  • Act as Global Regulatory Lead to drive matrix team engagement for a range of CEP portfolio assets and take ownership of lifecycle maintenance, including discontinuation of Marketing Authorizations (MAs).
  • Lead communication with regulatory agencies, specifically be the main point of contact with the European Medicines Agency and other European Local Health Authorities for National, Centralised and Mutual Recognition procedures products.
  • Ensure that the regulatory strategy delivers the needs of the Global and regional commercial and supply chain projects, while considering the regulatory needs of the local market(s).
  • Cultivate and sustain productive relationships with internal stakeholders, including regulatory labelling, CMC, medical, commercial, supply chain, and clinical teams.
  • Take proactive initiatives, demonstrating a keen ability to identify and escalate crucial issues early and actively contribute to crafting solutions.
  • Ensure compliance with global/regional regulatory life-cycle requirements (e.g., renewals, label updates, aggregate safety reports etc) and delivery of health authority commitments.
Requirements:
  • Degree in Biological or Healthcare Science.
  • Experience of all phases of the drug development process in regulatory affairs, with particular emphasis on maintenance and lifecycle management of marketed products.
  • In-depth understanding and practical experience of European Regulatory landscape and procedural requirements, guidelines and working practices is a must.
  • Knowledge of licensing requirements in other regions (APAC, LATAM, MENA) and experience with such Agencies is desirable.
  • Capable of being able to develop product / therapeutic knowledge in new area.
  • Ability to work in a complex environment.
  • Good communication and influencing skills.
  • Capable of delivering key communications with clarity, impact and passion.
Preferred Qualifications:
  • Ability to foster strong matrix working, facilitating dialogue between team and matrix members to contribute their ideas especially working remotely and in a virtual context with stakeholders.
  • Developing personal networks within GSK and capable of using them to secure appropriate support and outcome for a project.
  • Capable of identifying project or team issues in advance and seeking necessary help and support to resolve.
  • Ability to use a range of sources and weigh benefits and risks before making important decisions.
  • Focus on improving performance and excellence by challenging the ways of working and capable of developing and recommending strategies for change.
  • Understands regulatory governance, medical and safety.
Why GSK?

We offer a wide range of 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. We also offer 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. 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.

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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