Job Description :
Role: Business Analyst, Regulatory/Submissions experience
Location: Plymouth Meeting, PA.
Long term: CTH
Excellent communication skills required
Job Description:
Sr. Business Regulatory Analyst The Business Regulatory Analyst role is a business function activity with responsibility for performing regulatory analysis and cleanup activities on Submission Archive Content. Gathering of relevant requirements. Conduct and manager stakeholder meetings. The role includes communication between the Client Regulatory team and other members of the CGI team to determine Correspondence, Submission and Authoring content within existing submission archive repositories. General understanding of the regulatory landscape in regards to submissions such as eCTD, non-eCTD and NeeS. Candidates will have an understanding of EU regulatory standards such as CP, MRP and DCP and National submission. Willingness and ability to execute project functions for client delivery activities.
Responsibilities:
Working with the US Regulatory Team in partnership to complete client projects.
Ensure communication is complete, accurate, and provide communication enhancements as necessary.
Capable to interface with an India team member for knowledge and business rule transfer, process guidance, and key facilitation of communication between the India team and the US team.
Regulatory business experience and knowledge of the product approval lifecycle for product development to post marketing activities.
Submission dossier experience with an ability to recognize documents types for submission to Health Authorities versus HA Correspondences versus submission supporting documents.
Technical aptitude to learn new systems as end users.
Coding and system development experience is not required.
Regulatory operations experience with dossier management, submission, development to prove knowledge in identifying document types and purpose per Health Authority requirements.
Qualifications:
4+ Years'' experience in Regulatory Operations or related roles
Proven experience working with a cross-functional US / India Team on projects
Nice to have:
working with applications for projects and regulatory activities (e.g. InSight, Veeva, OpenText, Documentum, SharePoint, etc.
Ability to learn new systems user interface quickly. Strong Excel skills
Note: Momento USA is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.
Thanks,
Adam Walsh.
Momento USA | Exceeding Customer Expectations…
440 Benigno Blvd, Unit#A 2nd Floor. Bellmawr, NJ 08031
Interstate Business Park
Tel Ext 1003 ;Fax
Email: Web:
Note: Momento USA is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, pregnancy, sexual orientation, gender identity, national origin, age, protected veteran status, or disability status.