Regulatory Affairs Manager, CIS/Asia Cluster, EM Partner Markets

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

We are currently looking for a Regulatory Affairs Manager who will lead the Regulatory team within the EM Partner Markets organization as well as provide support including oversight and coordination of the operational matrix across Content Delivery, Region and Regulatory Third (3rd) Party Partners.

The purpose of the role is to ensure that all regulatory processes are developed and implemented, ensuring continuity of supply and conformance to applicable Regulations, Regulatory standards and governance.

Your responsibilities:

• Management of marketing authorizations (MAs) and coordination of associated activities for assigned markets including the primary interface with Content Delivery and 3rd Party Service Provider to support regulatory submissions to local regulatory agencies;

• Effective planning and tracking of regulatory activities for defined markets;

• Ensures that GSK Labeling (PI/PIL) is compliant with MA and with regulatory requirements and available in local language as applicable. Co-ordinates the completion of local language translations by 3rd Party CRO (as applicable);

• Ensures product information is compliant with MA and product pack changes are implemented in compliance with regulations and aligned to supply chain planning;

• Co-ordinates all regulatory submissions and commitments, ensuring these are in alignment with regulatory requirements and agreed strategy and timelines;

• Co-ordinates with Content Delivery the management of product registration documents and agency correspondence in regulatory databases and repositories;

• Builds and maintains effective relationships with, and provide considered regulatory advice, leadership, and expertise to cross functional stakeholders;

• Effective communication, collaboration, planning and oversight of Regulatory Third-Party service providers to achieve Regulatory objectives and meet compliance standards

• Participation and compliance in internal and external projects and activities.

• Lead Resource management, objective setting, performance and development of staff, talent reviews and succession planning, through a coordinated, well managed, strategically aligned program;

• Monitor and keep abreast of changes in the regulatory environments. Provide intelligence to relevant stakeholders and central teams on potential impact changes in the regulatory environment in the region.

Why you?

Basic Qualifications:

• Proven relevant experience in Regulatory Affairs

• 3-4 years line management experience

• Degree in scientific discipline (life sciences / pharmacy / professions aligned to medicine)

• Fluent English (speaking and writing)

• Effective collaboration and negotiation with regulatory agencies

• Strong project management skills

• Excellent communication and analytical skills

• Attention to details

Preferred Qualifications:

If you have the following characteristics, it would be a plus:

• Experience in the Regulatory Framework for drug registration in the EAEU (Eurasian Economic Union) would be beneficial 

• Fluent Russian desirable

• Work in complex regulatory environment.

• Ability to anticipate possible changes in the regulatory environment (relating to product development, NPI, and market access) proactively, to monitor their implementation, to assess and communicate possible risks and to prepare the mitigation strategy.

• Ability to multi task and excel in cross-functional settings and to manage multiple issues in a fast-paced environment.

• The ability to make decisions/influence outcomes that include assessment of the risk and impact on the business and using good judgment regarding when to refer issues to senior management.

Why GSK?

What we offer:

• Career at one of the leading global healthcare companies

• Contract of employment

• Attractive reward package (annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit)

• Hybrid working model (40% monthly time)

• Extensive support of work life balance (flexible working solutions, min. 2-3 days/week working form the office, short Fridays option, health & well-being activities)

• Life insurance and pension plan

• Private medical package with additional preventive healthcare services for employees and their eligible

• Sports cards (Multisport)

• Possibilities of development within the role and company’s structure

• Personalized learning approach (internal trainings, mentoring, access to online training’ platforms: Keep Growing Campus, LinkedIn Learning, Business Skills, Harvard Manage Mentor, Skillsoft and external training)

• Supportive community and integration events

• Modern office with creative rooms, fresh fruits every day

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The annual base salary in Poland for new hires in this position ranges from PLN 210,000 to PLN 350,000 gross, taking into account a number of factors including the candidate’s skills, experience, education level and the market rate for the role. Depending on the role and internal policies, the position may also be eligible for a bonus (if applicable and based on defined, non-discretionary criteria) and/or awards for exceptional performance (granted at the employer’s discretion). All statutory benefits will be maintained in accordance with Polish law. Other benefits may also be offered, which may include private healthcare, additional paid days off, life insurance, private pension plan and fully paid parental leave & care of family member leave. More detailed information on the total reward package applicable to your role will be supplied during the recruitment process. 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 market rate for the role.

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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