Regulatory Support Associate

OVERVIEW

Pace is seeking a Global Regulatory Document Manager in the Indianapolis area. This position supports global registration of new and existing Animal Health Products by coordinating, preparing and/or delivering registration documentation, data, samples, and reference standards to the global affiliates and agencies. This is done in a timely fashion to support meeting critical registration timelines and is carried out in compliance with Global Regulatory standards and guidelines.

RESPONSIBILITIES

• Support affiliates globally by reviewing, coordinating, and/or fulfilling requests for regulatory documents, document legalization, samples, and reference standards

• Initiate requests for government issued documents and prepare internally generated administrative documents originating from (but not limited to) USA, Mexico, Brazil, and New Zealand to support regulatory registration requirements globally.

• Route regulatory documents for signatures and legalization

• Print, scan and ship documents to government agencies and global affiliates and subsequently archive within regulatory information tracking system.

• Negotiate with affiliates and government agencies around document types and document availability

• Manage the LOA/POA template library

• Participate in special projects which support increased efficiency and/or process improvement

• Other responsibilities, as assigned, to support overall Regulatory objectives and goals

• Any other duties as requested by the Line Manager commensurate with the level of responsibility for this role, for which the employee has the necessary experience and/or training

• Comply with all company local and global policies including Quality frameworks, Code of Conduct, anti-discrimination, harassment, and health, safety and environment (HSE) policies.

QUALIFICATIONS

• Bachelor's Degree, preferably in a health-related or scientific field or a minimum of 3 years work experience in the pharmaceutical industry, drug development, or in regulatory affairs

• Prior Regulatory Affairs experience

• Multi-lingual (high preference for Spanish)

• Excellent organizational, project management, and time management skills

• Attention to detail

• Open, clear, and timely communication

• Strong inter-personal skills and ability to work effectively with cross-functional teams

• Understanding of the customer needs in order to drive effective solutions.

• Demonstrated ability to negotiate solutions to complex technical challenges

• Ability to work in a virtual setting across different cultures and time zones

IND2

OFCCP Statement

Pace Analytical is an Equal Opportunity Employer and will not discriminate against any applicant for employment on the basis of race, age, religion, sex, veterans, individuals with disabilities, sexual orientation, or gender identity.