Regulatory Affairs Jobs

Global Study Leader will have ultimate responsibility and accountability for study execution. The GTL will need to collaborate and coordinate cross-functionally and cross-regionally to execute the study when taking corrective action to address major study level issues and when making major study and site level decisions. The GTL will support multiple studies and may span a program as the GTL as program size and associated workload allows.

Job Responsibilities

Plan, manage and execute study
Ensure regulatory compliance and GCP adherence at the study level
Take corrective action for major study level issues (e.g. enrollment lagging across several regions)
Make major site level decisions (e.g. final site selection) based on input from the team
Plan, facilitate, and lead study team meetings
Provide direct input into the protocol writing process on operational aspects
Accountable for protocol execution across a study
Provide input during budget creation to GCPL

Global Study Leader will have ultimate responsibility and accountability for study execution. The GTL will need to collaborate and coordinate cross-functionally and cross-regionally to execute the study when taking corrective action to address major study level issues and when making major study and site level decisions. The GTL will support multiple studies and may span a program as the GTL as program size and associated workload allows.

Job Responsibilities

Plan, manage and execute study

*Ensure regulatory compliance and GCP adherence at the study level.
*Take corrective action for major study level issues (e.g. enrollment lagging across several regions).
*Make major site level decisions (e.g. final site selection) based on input from the team.
*Plan, facilitate, and lead study team meetings.
*Provide direct input into the protocol writing process on operational aspects.

Supervise Regulatory staff
• Support domestic registrations with FDA/CVM, including annual product reviews, recall support, post approval changes, standard operating procedures, reports, and interacting with regulators
• Responsible for Canadian regulatory including submissions, labeling approval, providing compliance guidance and interacting with regulators
• Provide regulatory guidance on compliance issues
• Provide regulatory support for manufacturing portion of international dossiers

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With limited supervision, coordinates the preparation and submission of various regulatory documents to health authorities. Working with input from supervisor, assures the quality and completeness of internal documents received for participates on regulatory teams for assigned projects/products.

1.Serve as the primary regulatory contact for specific projects and/or program related activities;
2. Serve as regulatory partner for category team;
2.Contribute to the assessment of new innovation projects and exploratory product development briefs;
3.Assist in the formulation of regulatory strategies designed to minimize time for development and regulatory approval and optimize competitive positioning and global opportunities;
4.Compile and submit quality core regulatory dossiers in line with business plans and timing needs;
5.Interact with GSK country regulatory managers and other regulatory agencies as necessary in relation to the development and marketing of products;
6.Collaborate with key cross-functional team members to meet or beat all project goals;
7.Review and approve all labelling, promotion, advertising, change controls, etc. for category products;

Primary objective will be to serve as legal advisor and counselor on a broad range of FDA regulatory matters to Wyeth Consumer Healthcare. Employee will work closely with the Chief Regulatory Counsel, Wyeth as well as the Chief Counsel, Wyeth Consumer Healthcare in connection with FDA regulatory matters for the consumer products business.

Responsibilities:

·Provide primary legal support on FDA related matters within the Consumer Products Division, including Global Regulatory Affairs, TO&PS, Commercial, and GSSE/L.
·Act as an expert resource on FDA-related legal matters for other segments of the Law Department, including Business Development, Litigation, Intellectual Property, Labor and Employment, and Privacy attorneys.
·Advise on legal and regulatory issues specific to over-the-counter drugs and dietary supplements including OTC monograph compliance and dietary supplement labeling and ingredient issues.

Merck & Co. Inc., established in 1891, is a global research-driven pharmaceutical company dedicated to putting patients first. Join us and experience our culture first-hand - one of strong ethics & integrity, diversified experiences and a resounding passion for improving human health. As part of our global team, you'll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

We are seeking a Pharmaceutical Specialty Sales Representative - Hospital Tablet for our Gainsville/Jacksonville, FL.

Join us and experience our culture first-hand — one of strong ethics & integrity, diversified experiences and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Under the direction of the Manager/Associate Director, Worldwide Product Labeling, assists with revising and updating product labeling for marketed products worldwide. Collects and reviews information pertinent to the safety and efficacy of marketed products. Assists in the preparation of revised labeling for circulation for approval throughout the Company. Presents proposed labeling revisions to the Label Evaluation and Development Team (LEAD) and the Label Approval Strategy Team (LAST). Reviews periodic reports and Adverse Drug Reaction Reports and prepares labeling summaries for these reports. Prepares annotated files of labeling for the Company.

Join us and experience our culture first-hand — one of strong ethics & integrity, diversified experiences and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.

Join us and experience our culture first-hand — one of strong ethics & integrity, diversified experiences and a resounding passion for improving human health. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.