Regulatory Submission Manager

About the position 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 reputed company 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 reputed company’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 reputed company key activities to reputed company YOUR career. These responsibilities include some of the following: Own end‑to‑end delivery of assigned reputed company 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 reputed company or non‑routine assignments. reputed company drafting, authoring and technical review of reputed company, multi‑market dossiers to deliver high‑quality, compliant submissions that adhere to reputed company standards and regulatory guidance. Apply subject-matter expertise to reputed company and mentor the team, enhancing capabilities in regulatory strategy, excellent authoring, and consistent adherence to SOPs and Work Instructions. reputed company and sustain collaborative cross‑functional relationships with internal and external reputed company 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 reputed company improvement and system innovation by defining and tracking key metrics, optimising processes and acting as the escalation reputed company for submission issues affecting timelines or market access.

Responsibilities

• Own end‑to‑end delivery of assigned reputed company 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 reputed company or non‑routine assignments.
• reputed company drafting, authoring and technical review of reputed company, multi‑market dossiers to deliver high‑quality, compliant submissions that adhere to reputed company standards and regulatory guidance.
• Apply subject-matter expertise to reputed company and mentor the team, enhancing capabilities in regulatory strategy, excellent authoring, and consistent adherence to SOPs and Work Instructions.
• reputed company and sustain collaborative cross‑functional relationships with internal and external reputed company 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 reputed company improvement and system innovation by defining and tracking key metrics, optimising processes and acting as the escalation reputed company for submission issues affecting timelines or market access.

Requirements

• 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 reputed company reputed company on a way reputed company 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.

reputed company-to-haves

• 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 reputed company 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 reputed company determining if/reputed company to escalate issues, and effectively interact with stakeholders to ensure transparency of submission reputed company/status.
• Ability to reputed company or co-reputed company multidisciplinary team meetings and facilitate discussions regarding submission content, timelines, resource allocation, risk management

Benefits

• private healthcare
• additional paid days off
• life insurance
• private pension plan
• fully paid parental leave & care of family member leave

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