Regulatory Support Associate

Posted 2 weeks ago
Pace®, Greenfield, IN 46140, Openings : 1,
Apply Here Job Description :

Pace is seeking a Global Regulatory Support Associate 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:

  • High School diploma required
  • 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 Requirements:

Pace® Life Sciences

Pace® makes the world a safer, healthier place. We advance the science of our pharmaceutical and biopharmaceutical customers through the drug development process, from early-phase R&ampD through clinical trials and GMP commercial product support. For customers with in-house manufacturing and labs, Pace® provides professional services to support their operations.



Req Benefits:

Benefits

80 hrs of paid vacation per year, 7 paid holidays per year, 2 floating holidays per year (prorated based on start date), 40 hrs paid sick time per year, paid bereavement leave (days based on relation to the employee), 8 hrs paid volunteer time per year, medical, dental, vision, voluntary short-term disability, long-term disability, life insurance, voluntary supplemental life insurance, traditional 401k and ROTH 401k with a company match, HSA, FSA, employee referral bonus, employee assistance program, tuition reimbursement program, employee recognition program, voluntary ID theft coverage, voluntary legal coverage, voluntary accident insurance, voluntary hospital indemnity insurance, and voluntary critical illness insurance.


Equal Opportunity Employer

Pace® provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, creed, color, religion, genetics, protected veteran status, national origin, sex, age, disability, marital status, sexual orientation, gender identity or expression, citizenship, or any other characteristic protected by federal, state or local laws. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.



Compensation: $55-60K Last Date For Apply: 2024-08-06 00:00:00 Job Type : FULL_TIME, Employment Type : FULL_TIMEApply Here