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Regulatory Strategist - Can work from one of several locations!

Kelly Services

Andover, MA
Job Code:
  • Business Development/Operations
  • Government
  • Regulatory Affairs
  • Project Management
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Job Details

Job Title Regulatory Strategist - Can work from one of several locations!

Jobid US33MXGR_BH1431479

Location: Andover, MA, 01810, USA

Description Kelly Services is seeking a Regulatory Submission Strategist for a long term assignment. The customer highly prefers candidates work onsite at one of the following locations: Collegeville PA, Peapack NJ, Groton CT, Andover MA, Lake Forest IL, La Jolla CA, or St. Louis MO.

The Regulatory Submission Strategist job activities shall include, but not be exclusive to:

+ Using GRA templates and source documentation from the technical/clinical teams (ideally loaded into customer’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 document management system, GRA templates and 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 customer 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 manufacturing 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 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.

+ Minimum Bachelor’s degree in a scientific discipline (e.g., chemistry, pharmacy, biology); advanced degree preferred.
+ 2-3 years of regulatory experience with demonstrated project management, interpersonal and leadership skills.
+ 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.
+ 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 Documentum-based dossier repositories.
If you meet the qualifications above and are interested in pursuing this opportunity, please submit your resume for immediate consideration!

**Perks of being a Kelly employee:**

+ Weekly electronic pay
+ Access to more than 3,000 online training courses though Kelly Learning center
+ Group rate insurance options available immediate upon hire*
+ Service bonus plan and holiday pay*
+ Online application system
+ Never an applicant fee
*perks to be received upon meeting eligibility requirements

**Important information: This position is recruited for by a remote Kelly office, not your local Kelly branch. To be considered for this position, you must use the Submit Resume or Apply Now button to submit your resume. If you have questions, the recruiter for this position can be reached via email at**

**Why Kelly** **®** **?**

With Kelly, you’ll have access to some of the world’s highest-regarded scientific organizations—providing you with opportunities to work on today’s most challenging, research-intensive, and relevantprojects. Our connections can lead you to innovative scientific pursuits you’ll be proud to helpadvance. We work with 95 of the Fortune 100™ companies, and found opportunities for more than 9,000scientific professionals last year.

You pursued a career in science to fuel your quest for knowledge and your desire to make the worlda better place. Let Kelly fuel your career—connect with us today.

**AboutKelly Services** **®**

As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 people around the world and have a role in connecting thousands more with work through our global network of talent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit and connectwith us on Facebook , LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.

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