The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.
One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.
Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.
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The purpose of this role is to:
Be the principle regulatory representative for the designated Portfolio/ Disease Areas within the Rare Disease Portfolio.
Provide global strategic expertise in rare disease drug development across the product lifecycle.
Oversee the designated Portfolio at the governance, strategic and technical level.
Be accountable for regulatory strategies, health authority interactions and effective Global Regulatory Sub Teams (GRST), ensuring aligned regional regulatory positions in place to support commercial goals.
Ensure regulatory deliverables in place and delivered to time, cost and quality for all projects in the portfolio.
Provide strategic guidance to projects and products through regulatory strategists reporting to him/her
Supervise, plan, develop and performance manage regional and global regulatory strategist talent within the Rare Disease line.
Champion flexible approaches to ensure efficient and effective resource utilization.
Support the GRA Leadership Team and drive the required culture, learning and behaviors through the organization.
Senior global regulatory representative within the specified portfolio/disease areas, at the governance, strategic, technical, and portfolio level responsible for regulatory decisions
Accountable for ensuring contribution to Global Regulatory Strategies, Medicines Plan(s), and implementation plans (including core labels, risk registers, LADs) for assigned portfolio.
Responsible for developing and maintaining an in-depth regulatory knowledge of the portfolio including current and emerging global guidelines and regulators, relevant regulatory approaches and actions; and status of competitor products.
Ensures regulatory contributions (pre and post market approval) achieve the objectives in the strategy, achieve agreed standards, maximizing overall project delivery time and probability of success.
Partners with the Development Teams and other internal stakeholder groups (e.g. Research Unit/Business leads, Regional Commercial Teams) to ensure required regulatory contributions (e.g. line plans, health authority interactions, rare disease designations, CTA, MAA, labelling, post-approval activities etc.) meet business needs and are provided to the project teams, to agreed time and quality standards.
Ensures regulatory plans are monitored and progress/variance communicated to GRLs and Senior Management and any risks (from emerging technical data, changing internal objectives or external entities) are mitigated.
Ensures an aligned global regulatory position is reached and communicated for all key issues for assigned project/s, and that these regulatory positions supporting the regional and global business are championed and communicated.
Engages in appropriate activities in order to influence the regional regulatory environment through GRA-In Country colleagues, Agency contacts and/or Trade Associations as appropriate.
Ensures business compliance and implementation of and adherence to Regulatory standards.
Develops novel concepts and approaches to advance and/or challenge existing regulatory paradigms in support of pipeline products.
Develops strong and positive working relationships with regulators, professional bodies, external experts and opinion leaders.
Works closely with regulatory colleagues across sites, countries and Categories to ensure consistent approaches to Health Authorities.
Engages in appropriate activities to influence the regulatory environment.
Responsible for aggregate resource forecasting for the projects/products within assigned portfolio.
Mentors, develops and coaches Regulatory Strategists/GRLs for projects within the relevant portfolio including all aspects of the performance management process as appropriate.
Provides guidance to all regulatory professionals within the area of responsibility to prepare for health authority interactions and external and internal project/product presentations.
Works with other regulatory staff to ensure application of consistent processes and policies across GRA. Directly responsible for assuring implementation of these processes and policies.
Member of the extended leadership team GRA Rare Disease; Supports the GRA leadership team and drives the required culture, learning and behaviors through the organization.
10-15 years of substantial regulatory experience in early and late stage development or relevant experience with an Advanced Scientific Degree (MD, PhD, PharmD, M.Sc.) for a Sr. Director level role.
Demonstrable experience in drug development or relevant experience in the Pharmaceutical industry, preferably in Drug Development or Clinical Research, ideally within Regulatory Affairs / Health Authority and/or a proven track record of success in negotiating with Health Authorities and in representing interests to internal and external stakeholders.
Knowledge of assigned therapeutic areas / disease areas; experience in early and full development of novel therapeutics.
In depth and relevant Global regulatory experience (more than one region).
Demonstrated strategic thinking and ability to integrate strategies into actionable plans; exhibits innovative thinking.
Proven ability to function autonomously at a senior level in a highly matrixed organization; exhibits business acumen. Proven experience in managing global and/or regional regulatory process and registration aspects of the drug development process is required.
Knowledge of drug development practice rules, regulations and guidelines - Familiarity with factors likely to influence the regulatory environment, including new and emerging guidelines.
Proven ability in developing and implementing regulatory strategy - Understanding of regulatory agency philosophy and guidelines. Experience preparing and submitting INDs and/or CTAs, NDAs, BLAs / MAAs. Working with and influencing regulators and opinion leaders, facilitating approval of submissions with labeling meeting corporate expectations
Communication skills - Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management.
Presentation skills - Is effective in a variety of formal presentation settings; one-on-one, small and large groups, with peers, direct reports and senior managers.
Negotiation skills - Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations
Other Job Details:
Last Date to Apply for Job: October 26, 2020
Eligible for Employee Referral Bonus: YES
Internal Number: 4792828
About Pfizer Inc
Pfizer Global Research and Development (PGRD), Pfizer’s discovery and development division, is one of the finest pharmaceutical research institutions in the world. Our focus is clear - to discover and deliver an ever-increasing variety of medicines to significantly enhance the health and quality of life for people and animals around the world. We accomplish this with multidisciplinary teams of scientists and technology professionals who perform exemplary science, innovation and extraordinary teamwork.
Pfizer’s success is evident in our industry-leading pipeline of drugs. Our search for new treatments spans hundreds of research projects across 31 major disease groups and therapeutic areas - more than any other company on the globe. Included are oncology, anti-infective and anti-virals, central nervous system, cardiovascular, diabetes, obesity, and ophthalmology. Pfizer is responsible for many recognized drug breakthroughs that rank first in sales in their class, including several with which you may be familiar -- Lipitor (for high cholesterol), Zithromax (an oral antibiotic), Norvasc (for hypertension), and Viagra (for erectile dysfunction).