Regulatory Submission Manager

Site Name: Mississauga Milverton Drive, Bengaluru Luxor North Tower, Greater Poland, Mexico - Federal District - Mexico City, Mumbai Floral Deck Plaza
Posted Date: Jan

Position Summary
The job holder is responsible for managing end-to-end regulatory lifecycle submissions across multiple markets, ensuring timely delivery and compliance with regulatory authority requirements, guidance and GSK processes, including written standards. The role coordinates with cross-functional teams to execute lifecycle management activities, mentors and develops team members, and enforces Regulatory registration requirements, to maintain regulatory compliance and support GSK's global product strategy. This role involves serving as a Subject Matter Expert to address escalations and drive improvements in regulatory processes, supporting organizational objectives and ensuring compliance with global regulatory standards

This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include some of the following:

• Own end‑to‑end delivery of assigned complex lifecycle regulatory submissions (e.g., variations, PBRERs, renewals, site registrations/renewals, tenders, etc.), ensuring they meet agency requirements, agreed dossier strategies and timelines while proactively managing risks and remediation.
• Provide peer review and quality assurance of deliverables; support authors on complex or non‑routine assignments.
• Lead drafting, authoring and technical review of complex, multi‑market dossiers to deliver high‑quality, compliant submissions that adhere to GSK standards and regulatory guidance.
• Apply subject-matter expertise to lead and mentor the team, enhancing capabilities in regulatory strategy, excellent authoring, and consistent adherence to SOPs and Work Instructions.
• Develop and sustain collaborative cross‑functional relationships with internal and external GSK stakeholders like manufacturing sites, regulatory authorities or third-party service providers to coordinate submission deliverables, address concern, resolve issues and implement fit‑for‑purpose regulatory strategies.
• Drive continuous improvement and system innovation by defining and tracking key metrics, optimising processes and acting as the escalation point for submission issues affecting timelines or market access.

Why You?

Work arrangement
This role is offered as a hybrid position. You will be expected to work regularly from the office for team collaboration and stakeholder meetings.

Basic Qualification

• Preferably more than 8 years relevant regulatory/submission experience.
• In-depth knowledge of regulations, guidelines, and policies for pharmaceutical and vaccine registration and manufacturing.
• Ability to interpret regulations and gain consensus on a way forward in an environment where there may be more than one way of achieving a successful outcome.
• Ability to effectively interact with line and middle management, staff and external contacts on a functional and strategic level in a matrix environment.
• Ability to think flexibly in order to meet constantly shifting priorities and timelines.

Preferred Qualification

• Excellent written and verbal communication skills and ability to present information in a clear and concise manner.
• Excellent organisational skills, attention to detail and commitment to deliver high quality output, even under pressures sometimes demanded by regulatory deadlines.
• Project management experience in the pharmaceutical industry or in a regulatory environment including knowledge of project management tools.
• Ability to lead in a matrix environment and ensure delivery of objectives across cross-functional teams.
• Ability to proactively identify and mitigate risks and potential bottlenecks, apply sound judgement when determining if/when to escalate issues, and effectively interact with stakeholders to ensure transparency of submission progress/status.
• Ability to lead or co-lead multidisciplinary team meetings and facilitate discussions regarding submission content, timelines, resource allocation, risk management

#LI-Hybrid

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.In compliance with Ontario's provincial pay transparency legislation, this job posting includes a salary range to support equitable and informed hiring practices. The annual compensation for this role is CAD106,000 to CAD156,000 , determined based on experience, qualifications, and internal equity. GSK is dedicated to promoting transparency and fairness throughout our 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.

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.

Inclusion at GSK:

As an employer committed to Inclusion, we encourage you to reach out if you need any adjustments during the recruitment process.

Please contact our Recruitment Team at IN.recruitment- to discuss your needs.

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