Manager, Regional Regulatory Strategist - Sterile Injectables

Manager, Regional Regulatory Strategist - Sterile InjectablesPfizer is committed to breakthroughs that change patients' lives.

We pursue innovations to bring life-changing medicines to the world and seek professionals who share this mission.

This role represents a region for regulatory affairs (US, EU or EM) and provides regional strategic expertise to relevant forums.

The role leads and implements regional regulatory strategies in agreement with key stakeholders, aims for timely submissions and approvals with commercially attractive labeling in the designated region, and serves as the main point of contact with Health Authorities for the assigned project(s).

Role may be combined with other Regulatory Roles (e.g., Global Regulatory Lead).

Operational support includes researching regulatory background for products in scope.JOB SUMMARYRepresent a particular region for regulatory affairs (US, EU or EM).

Provide regional strategic expertise to relevant forums (e.g., GMT, Global Regulatory Strategic Team).

Lead and implement regional regulatory strategies in agreement with key stakeholders for assigned projects / products and in line with commercial goals.Be accountable for timely submissions and approvals with commercially attractive labeling in the designated region.Be accountable as the main point of contact with Health Authorities for the assigned project(s) within the designated region.Role can be combined with other Regulatory Roles (i.e., Global Regulatory Lead).

Provide operational support of activities (e.g., researching regulatory background for products in scope).

JOB RESPONSIBILITIESAccountable for ensuring regional (US, EU or EM) contribution to Global Regulatory Strategies and implementation plans (including core labels and risk registers) for assigned projects.Ensure regulatory contributions achieve objectives in the strategy, to agreed standards, maximizing overall project delivery time and probability of success and facilitating post filing activities.Partner with project teams and other groups to ensure required regulatory contributions (line plans, label, CTA, MAA / IRD, variations, license renewals, etc.) meet business needs and are provided to project teams to agreed time and quality standards.Monitor regulatory plans, report progress / variance to GRL and Senior Management, and mitigate risks from emerging data or external threats.Reach and communicate an aligned regional regulatory position for key issues, and champion these positions to support the regional business.Engage in activities to influence the regional regulatory environment through in-country colleagues, agency contacts and / or trade associations as appropriate.Ensure compliance with regulatory standards and maintain constructive relationships with Health Authority contacts in the assigned region.Maintain information in regulatory systems and support data analysis and mining as needed.Support operational activities including submissions coordination, responses to regulatory queries, labeling, market requirements management, and other regulatory tasks.Support creation and maintenance of internal trackers and submission documents including QC and gap analysis.Provide regular updates on work progress and highlight critical developments or risks requiring leadership attention.QUALIFICATIONS / SKILLSEducation / Experience : BS / BA (Pharmacy, Chemistry, Biology, or related science) with 5+ years of related technical experience or MS with 3+ years of related experience or PhD with