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Regulatory Strategist


Augusta, GA 30901
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Job Details

Role Summary:

+ Reports to the Therapeutic Area Cluster LeadAssist in developing and implementing regulatory strategy that aligns with business needs, including growth projects and activities relating to maintaining registrations, product defense and regulatory complianceContribute to regulatory strategy and operational activities for projects/products, including the preparation and submission of correspondence and applications to regulatory agencies.Participate in Regulatory and cross functional teams for assigned projects/products.With appropriate supervision, direct and/or indirect liaison with Health Authorities (in conjunction with Country Regulatory Leads (CRLs)) to facilitate the prompt review and approval of applications, supplements/variations, and commitment closures.Role Details:

+ Under the supervision of the Therapeutic Area Cluster Lead:

+ Contributing to development of Global/Regional regulatory strategies and implementation plans developed for assigned projects/products., Ensuring regulatory contributions achieve the strategic objectives, meet agreed standards and project delivery timelines, whilst optimizing probability of success and facilitating post-filing activities.

+ In partnership with Strategy Lead, ensure business compliance, and implementation of and adherence to regulatory standards.

+ Partnering with project teams and other customer groups (e.g., Country Regulatory Managers, Cross functional product teams, PGS, etc.) to ensure required regulatory contributions (,briefing documents, Global Regulatory Strategy Documents, annual reports, IND, NDA, MAA, etc.) meet business needs and are provided in accordance with agreed time, cost and quality standards.

+ Accountable for executing regulatory information searches for inspection readiness, Rapid response teams, etc. Database searches include RADARS and GDMS to contribute to strategic and historical analyses and decisions

+ Accountable for managing submissions to ensure completeness and timeliness of submission package. Participates on project teams for assigned projects/products and actively coordinates and follows up with partner lines to ensure fit-for-purpose submission packages. Tracks, analyzes and solves submission problems for assigned projects/products and develops clear project plans and timelines for priority products, projects or portfolios as needed.

+ Working closely with other Regulatory Strategists and CMC Team within and across clusters/TAs and sites to ensure consistent and appropriate processes, systems, working practices, shared learnings and quality standards.

+ Implementing systems, processes and procedures relating to regulatory strategy productivity improvements, ensuring the sharing of information and learnings across the relevant lines.

+ Plays a supporting role in any appropriate activities in order to influence the regulatory environment through Agency contacts and Trade Associations as appropriate.

+ Develops and maintains constructive working relationship with Health Authority contacts. Qualifications and Experience:

+ Bachelor degree in a science subject together with appropriate pharmaceutical industry experience gained within a global regulatory affairs function.

+ Knowledge of the regulatory environment and how this impacts regulatory strategy development and implementation and awareness of the functioning of the pharmaceutical industry

+ Ability to manage complex issues with appropriate support, such as global and/or regional regulatory and registration activities involved in the drug development process and/or post-marketing lifecycle management or leveraging regulatory policy issues to support commercial objectives

+ Proven ability to partner successfully with Regulatory, Commercial, Safety, Medical and other partner lines to achieve objectives.

+ Awareness of and ideally experience in successfully communicating with Health Authority(ies), is preferred

+ Strong problem solving skills

+ Strong written and verbal communication skills. Ability to work well with appropriate level of independence and appropriate level of supervision The closing deadline for applications is December 15th. All applicants must have the relevant authorisation to live and work in the UK.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.
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