Regulatory Project Manager

6 miesięcy temu

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

We are looking for an ambitious Regulatory Project Manager to ensure the development of regulatory strategy(ies) and their execution for assigned asset(s) consistent with the strategic activities for GSK’s Classic & Established Product (CEP) portfolio. This goal must be achieved while ensuring compliance with both internal GSK process / policy and with appropriate regulatory requirements. 

We create a place where people can grow, be their best, be safe, and feel welcome, valued and included. We offer a competitive salary, an annual bonus based on company performance, healthcare and wellbeing programmes, pension plan membership, and shares and savings programme.

We embrace modern work practises; our Performance with Choice programme offers a hybrid working model, empowering you to find the optimal balance between remote and in-office work.

Discover more about our company wide benefits and life at GSK on our webpage

In this role you will

Act as Global Regulatory Lead to drive matrix team engagement for a range of CEP portfolio Assets and take ownership of for the life cycle maintenance, including discontinuation of Marketing Authorizations (MAs), including 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.

Basic Qualifications & Skills:

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

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 & Skills:

Please note the following skills are not necessary, just preferred, if you do not have them, please still apply:

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 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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