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Regulatory Affairs Associate

2 months ago

Warwick, Rhode Island, United States Hallo Healthcare Group Full time
About The Position

Role Overview:


The Regulatory Affairs Associate will support the Regulatory Affairs Lead and Senior Regulatory Affairs Specialist in executing responsibilities related to Parallel Trade, encompassing regulatory compliance and quality assurance.


This role involves collaboration with the Regulatory Affairs team to uphold the highest standards in implementing Quality and Regulatory Strategies, adhering to relevant legislation and guidelines.


The Associate will ensure that new licenses are processed with utmost precision, making them readily available for production teams.


Key Responsibilities:
  • Timely submission and implementation of new licenses and variations.
  • Collaboration with regulatory teams to manage license applications effectively.
  • Engagement with cross-functional teams to facilitate timely procurement and production of stock.
  • Utilization of Quality Management Systems to maintain compliance with regulatory standards.
  • Continuous professional development through training on new procedures and processes.
  • Identification and escalation of regulatory risks as necessary.
  • Preparation of new license applications to minimize requests for information from regulatory bodies.
  • Provision of support to production and quality assurance departments.

Why Choose Hallo Healthcare Group?

Hallo Healthcare Group is a prominent player in the pharmaceutical supply chain, impacting communities nationwide. Our commitment to delivering essential medicines ensures that we make a significant difference in the lives of many.

We believe in continuous improvement, investing in our future by enhancing our operational capabilities to ensure efficient and safe delivery of our products.

Joining our team means access to extensive training and development opportunities, paving the way for career advancement in various pathways, whether in management, regional roles, or corporate positions.


Benefits:
  • Generous annual leave policy.
  • Pension scheme and company bonus structure.
  • Comprehensive parental leave policies.
  • Employee assistance program, including health and wellness resources.

Candidate Profile:

Qualifications and Experience:
  • Experience in Regulatory Affairs and Parallel Trade.
  • Thorough understanding of the pharmaceutical sector and its regulatory environment.
  • Familiarity with Quality Management Systems and regulatory compliance processes.
  • Strong organizational and proactive skills.
  • Excellent communication and teamwork abilities.
  • Analytical mindset with proficiency in data analysis tools.
  • Experience with software related to labeling and compliance.

About Us:

Hallo Healthcare Group is dedicated to ensuring that millions of individuals receive their necessary medications. As a leading distributor of pharmaceutical products, we serve a wide range of healthcare providers across the country.

Our operations span the entire supply chain, from manufacturers to end consumers, offering a comprehensive range of healthcare products.

We are committed to diversity and inclusion, ensuring a fair and equitable recruitment process for all candidates.