Regulatory Strategist II

Less than 5 years experience  • 

Salary depends on experience
Posted on 05/08/18 by Chitrank Rastogi
Confidential Company
La Jolla, CA
Less than 5 years experience
Salary depends on experience
Posted on 05/08/18 Chitrank Rastogi

* For Regulatory Submission Strategy/Authoring, activities shall include, but not be exclusive to: prepare/author regulatory sections (e.g. QOS and Module 3) for clinical trial applications and amendments, registration dossiers, annual reports and post-approval variations and renewals.

* Submission preparation will be done within the Pfizer document management system, GRA templates and Pfizer defined format; develop regulatory post-approval filing strategies and variations for global products; prepare regulatory sections for US Annual Reports; ensure that regulatory documents are prepared accurately, completely and on-time;

* Manage post-approval changes for products manufactured at Pfizer facilities and contract manufacturers;

* Prepare responses to Health Authority queries and requests and liaise with Global Regulatory Team to progress the submission/project support as required.

For Regulatory Submission Strategy/Authoring, activities shall include, but not be exclusive to, the following:

* Using GRA templates and source documentation from the technical/clinical teams (ideally loaded into Pfizer?s document management system), prepare/author regulatory sections (e.g. QOS and Module 3) for clinical trial applications and amendments, registration dossiers, annual reports and post-approval variations and renewals.

* Submission preparation will be done within the Pfizer document management system, GRA templates and Pfizer defined format;

* Prepare and update regulatory sections of Marketing Authorizations;

* Develop regulatory post-approval filing strategies and variations for global products;

* Prepare regulatory sections for US Annual Reports; ensure that regulatory documents are prepared accurately, completely and on-time;

* Manage post-approval changes for products manufactured at Pfizer facilities and contract manufacturers;

* Prepare responses to Health Authority queries and requests;

* Prepare DMF and CEP dossiers in submission ready format according to FDA and EDQM guidelines;

* Develop strong working relationships and act as primary interface between Mfg sites and Regulatory Affairs on CMC change dossiers;

* Liaise with Global Regulatory Team to progress the submission/project support as required;

* Activities may include submission-specific strategy development in collaboration with regulatory lead, including data verification/QC of regulatory submission sections against verified source documentation.

* Work with Pfizers biosimilar business unit, including asset team representatives for projects (including Asset team leaders, clinical leads, safety leads) under the guidance of the global regulatory lead.

Qualification

* A minimum of 3-5 years of regulatory experience with demonstrated project management, interpersonal and leadership skills.

* Minimum Bachelor?s degree in a scientific discipline (e.g., chemistry, pharmacy, biology); advanced degree preferred.

* Extensive knowledge and strategic understanding of the principles, concepts and practices of a discipline and broad working knowledge of principles, practices, operations and concepts in other relevant disciplines

Additional Skills:       

* Broad functional knowledge of pharmaceutical sciences and clear understanding of drug development or manufacturing/improvement processes

* Advanced knowledge of global CMC regulations and guidelines

* Excellent communications skills (both written and verbal), with strong technical and regulatory writing ability.

* Proven experience in multi-tasking and prioritizing projects.

* Strong knowledge in global post-approval Chemistry, Manufacturing and Controls (CMC) change regulations, and in the content and structure of the CMC section of a Marketing Authorization.

* Ability to participate as A representative on cross-functional project teams, and effectively work with multiple disciplines and personalities.

* Broad exposure to global Health Authorities? requirements

* Must have a thorough understanding of CMC regulatory change management requirements; possess a strong working knowledge of FDA regulations and other global authorities' CMC/compliance requirements.

* Experience with Documented-based dossier repositories.

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