100% REMOTE Regulatory Specialist - Remote | CareerCircle
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100% REMOTE Regulatory Specialist

Actalent

02/08/2022

Posting ID: JP-002629780

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Description:

• 3+ years relevant pharmaceutical industry and regulatory experience

• Pharmaceutical Rx (not generics) development strategy experience highly preferred

• Medical device experience a plus

• Bachelor’s degree in science or health related field

Key Activities / Job responsibilities

• Responsible for preparing, authoring submissions to health authorities

• Liaises with regulatory counterparts to ensure regional requirements are incorporated into product strategy development

• Develops a product regulatory timeline aligned to organization defined product development, with key regulatory milestones, and activities for health authority filings

• Ensures labeling content and product documentation is developed in accordance with regulatory requirements

• Participates as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions

• Coordinates with Regulatory Operations group to ensure timely and accurate submissions to Regulatory Authorities

Qualifications

• Knowledge of pharmaceutical brand industry regulatory affairs discipline throughout the product lifecycle, including Development, Labeling, CMC, Commercialization, and Operations

• Knowledge of domestic laws, regulations, and guidance that affect Brand products

• Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses

• Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for Brand products

• Ability to partner with cross-functional teams in a pharmaceutical organization

• Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly, and conclusions are adequately supported by data

• Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

Contact Information

Recruiter: Jean Chambers

Phone: (410) 579-3072

Email: jchambers@careercircle.com

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