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Reg. Strat. Coord. Innovative

Pfizer


Location:
San Jose, CA 95116
Date:
04/03/2018
2018-04-032018-05-04
Pfizer
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Job Details

+ **Position purpose**



+ To participate in the planning, defining, implementing and monitoring of appropriate regulatory strategies and processes to ensure the marketing of Pfizer products under his/her responsibility, including the health registration applications of new products and line extension, renewals, amendments, labelling and artworks, among others, according to the health regulations in force in the country or countries that support and company policies in line with corporate needs and / or business departments.



+ To provide accurate and timely information about the products which are under his/her responsibility for the country or countries of responsibility



+ To support company on regulatory issues associated with the products under his/her responsibility.







PRIMARY RESPONSABILITIES







+ Support strategy for the obtaining of registrations, modifications and renewals of health registrations of the products under his/her responsibility, coordinating response to the requirements presented by the health authority



+ Apply the country's regulatory expertise in communicating documentation to prepare a dossier for the health procedure according to the health agency, ensuring high quality information and compliance with Pfizer standards.



+ To co-ordinate with the Regulatory Strategist Regional Hub, the dossier receipt for new products and line extension and response to additional requirements of products under the charge of this position, to ensure the submission of dossiers in compliance with local regulations and required response times.



+ To co-ordinate with Regulatory Strategist Regional Hub the dossier reception of post-approval changes, renewals and response to additional requirements of products under the charge of this position, to ensure the submission of dossiers in compliance with local regulations and required response times.



+ Define the strategy for labelling and artwork updates with the local responsible person to manage the CMC, safety or legal entity changes with an impact on the labelling and artwork of each product.



+ To review and approve promotional materials of products under this position's charge so that promotional materials are in accordance with health regulations, avoiding destructions or penalties for breach of regulations.



+ Develop partnership with in-country teams (e.g. Quality, Medical, Marketing, Supply Chain), to facilitate the implementation/execution of regulatory strategies to expedite the registration of new products, line extensions, post approval changes and life-cycle optimization.



+ Assure the regulatory electronic systems and tools are updated to share accurate regulatory information with local and above country areas (GCMC, Hubs, local teams, etc).



+ Provide regulatory support to Innovative Business Units and platform local areas (Supply, Quality, Safety, etc) to contribute to the achievement of business objectives.



+ Support tenders preparation.



+ To prepare reports required by the Regulatory Affairs Head of the Cluster for the products under this position's.



+ To help the supporting / business departments of the company in regulatory issues associated with the products under this position's charge, providing input to the marketing and commercial teams in relation to processes and regulatory strategies.



+ To provide input to Regulatory Strategist Regional Hub of the regulatory strategy for the development and registration of products in line with business objectives, ensuring strategies that properly reflect each country's plans and aligning regulatory activities with business plans relevant to country or countries under his/her responsibility



+ To receive and review BoH (Board of Health) correspondence for products under his position's responsibility that must be managed base on internal SOP and procedures.



+ To execute the activities required during an AQRT processes previously defined with the Regulatory Affairs Head.



+ To Interact with Health Authorities, local registration contact (outsource) and local regulatory affairs associations, according local needs and strategies defined with Regulatory Affairs Head of the cluster.







**Technical Skill Requirements**







+ In-depth knowledge of the current health regulatory framework for drug regulatory procedures.



+ Desirable knowledge in biological and biotechnological products, Quality Control and / or production



+ Planning and Organization



+ Tracking



+ Quality Focus



+ Customer Orientation



+ Analysis and problem solving



+ Influence



+ Negotiation



+ Effective Communication



+ Strategic thinking



+ Office intermediate



+ English Advanced







Qualifications







+ Academic Degree: Pharmacist



+ A minimum of three to four years of experience in drug regulatory affairs as analyst or coordinator with demonstrated success in managing health registrations processes for Central America and Caribbean, meeting high standards of quality and pertinence.



+ Demonstrated success in effectively managing and optimizing standards in regulatory information systems.



+ Successful experiences of teamwork, seeking and proposing alternative solutions, achieving goals in an inclusive manner







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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