Regulatory Manager, SDE - STS

Descripción del puesto:

The Submission Technical Support Team Manager will hold managerial responsibility for direct reports and is accountable for the completion of assigned tasks within their domain. Additionally, the Manager serves as the point of escalation for matters concerning resource allocation or quality considerations.
This position involves influencing stakeholders within and beyond GRA and driving harmonization and business change activities within the function, in addition to ensuring on time and quality delivery of submissions for R&D projects.
This role provides Regulatory management to link the business mission, strategy, and required processes to fulfil GSK's obligations with Health Authorities related to Regulatory submissions and will contribute to driving continuous improvement and innovation of GSK Regulatory systems and processes.

Key Responsibilities:
* Manage HR aspects for a team of direct reports including recruitment.
* Manage workload within assigned team and work with other managers within functional area to address resource challenges.
* Provide peer review and quality check support as requested and able.
* Serve as point of escalation for team members.
* Advise and assist authors with more complex or non-routine assignments.
* Participate in quality or continuous process improvement activities related to area of responsibility or as requested.
* Maintain appropriate organizational networks.
* Independently and confidently executes agreed assignments strategy.
* Understands regulations, guidelines, procedures, and policies relating to registration and manufacturing of pharmaceutical products/registration data management/submission format to expedite submission, review, and approval of global applications.

​Basic Qualifications:
*  Strong interpersonal and communication skills, with the ability to build and maintain relationships and effectively manage team dynamics.
*  HA experience of Pharmaceutical Regulatory Affairs covering a breadth of global regulatory procedures, particularly those related to global submission requirements.
*  Good knowledge of relevant regulations and standards relating to the submission of regulatory applications worldwide.
*  Ability to lead the coordination of submission delivery activities as an integral member of a Regulatory Operational team.
*  Ability to work well both independently and within or leading a team to ensure on-time delivery of objectives/projects.
*  Demonstrated Project Management skills, overseeing and prioritizing multiple activities across one or more sites for multiple customers.
*  Ability to work with and add value to matrix teams in a globally diverse organization.
*  Ability to define and implement new processes and quality initiatives with an awareness of relevant controls and impacts.

Benefits:

* Career at one of the leading global healthcare companies
* Attractive reward package (competitive salary, annual bonus & awards for outstanding performance, recognition awards for additional achievements and engagement, holiday benefit
* Possibilities of development within the role and company's structure
* Life insurance and pension plan
* Private medical package with additional preventive healthcare services for employees and their eligible counterparts
* Sports cards (Multisport)
* Personalized learning approach and external trainings
* Extensive support of work life balance (flexible working solutions including working from home possibilities, health & wellbeing activities)
* Supportive community and integration events
* Modern office with creative rooms, fresh fruits everyday
* Free car and bike parking, locker rooms and showers

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What we value in you
You communicate clearly and act with practical judgement. You take ownership, work well across teams and focus on outcomes that matter. You look for ways to improve how we work and support colleagues to deliver high-quality regulatory outcomes. If you want to grow your regulatory career and make a real difference to patients, please apply. If you need adjustments during recruitment, tell our Recruitment Team so we can support you.The annual base salary in Poland for new hires in this position ranges from PLN 198,000 to PLN 330,000 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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