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Regulatory Strategist II

Kelly Services


Location:
Andover, MA
Date:
04/23/2018
2018-04-232018-05-22
Job Code:
US41L7BS_BH1431478
Categories:
  • Business Development/Operations
  • Government
  • Regulatory Affairs
  • Project Management
Kelly Services
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Job Details

Job Title Regulatory Strategist II

Jobid US41L7BS_BH1431478

Location: Andover, MA, 01810, USA

Description Kelly Services® has been providing outstanding employment opportunities to the most talented individuals in the marketplace. We are proud to offer a long-term temporary opportunity to work as a **Regulatory Strategist** at a prestigious Fortune 500® company working in **Andover, MA.**

**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” button to submit your resumes. If you have questions about the position, you may contact the recruiter for this position ( Brooke.Schoen@kellyservices.com ) however your resume must be received via the “Submit Resume” button included within.

**Job Title:** **Regulatory Strategist**

**Summary**
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 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 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 asset team representatives for projects (including Asset team leaders, clinical leads, safety leads) under the guidance of the global regulatory lead.

**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 Documentum-based dossier repositories.

**Education & Experience** :

• 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

**Travel & Location**

Potential for travel
- Prefer onsite but remote options are possible
- Onsite locations: Collegeville, Peapack, Groton, Andover, Lake Forest, La Jolla, St. Louis

**We invite you to bookmark our Web site and encourage you to review it regularly for new opportunities worldwide:** www.kellyservices.com at http://www.kellyservices.com/ **.**

**_Kelly Services® is a U.S.-based Fortune 500 company. With our global network of branch locations, we are uniquely positioned to provide our customers with international staffing support and our employees with diverse assignments around the world._**

**Kelly Services is an Equal Opportunity Employer**

**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 kellyservices.com 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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