Manager, Regional Regulatory Strategist - Sterile Injectables
Pfizer 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 SUMMARY
- Represent 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 RESPONSIBILITIES
Accountable 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 / SKILLS
Education / 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
Preferred Qualifications :
Proven experience in managing national and / or regional regulatory process and registration aspects of drug development and / or post-approval study requirements.Experience as a national / regional regulatory liaison for at least one product in different therapeutic areas; familiarity with generic / non-innovative registrations and in different life cycle stages. Equivalent experience (e.g., regulatory agency or industry-government collaborations) can be considered.Experience communicating with FDA or major EU regulatory agencies for US and EU strategists, and participating in / leading such interactions.Knowledge of drug development practice rules, regulations and guidelines; familiarity with emerging guidelines and factors influencing the regulatory environment.Proven ability to develop and implement regulatory strategy; understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs and / or CTAs, NDAs / MAA / IRDs; ability to influence regulators and executives to facilitate approval with labeling meeting corporate expectations.Ability to communicate complex information to diverse scientific audiences in English; proficient at conveying strategic and tactical issues to management and escalating risks and complex submissions.Effective presentation skills in formal settings with diverse audiences.Negotiation skills : able to negotiate with internal and external groups; capable of being direct, forceful, and diplomatic while earning trust.ORGANIZATIONAL RELATIONSHIPS
Works with PRD / GRS colleagues and project teams across functions (e.g., Clinical, Development, Medical, Safety and Risk Management, Pharmaceutical Sciences, Global Supply, Legal).Partners with regional colleagues, including GRS-in Country colleagues, Medical and Commercial teams, to provide a regional position.Works with external contacts in Regulatory Agencies within the assigned region, as well as relevant experts.RESOURCES MANAGED
Dependent on level.
Values and Inclusion
Pfizer is an equal opportunity employer. We are committed to creating an inclusive environment for diverse backgrounds and experiences. We encourage applicants from all backgrounds to apply and will provide reasonable accommodations as needed.
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