Regulatory Associate

PennVeterinary Supply, Inc•West Hempfield Township, PA

8d•Onsite

About The Position

The Regulatory Associate plays a crucial role in ensuring compliance with applicable laws, regulations, and standards in a specific industry, such as pharmaceuticals, medical devices or chemicals. They are responsible for researching, interpreting, and implementing regulatory requirements to support the company efforts. The Regulatory Associate collaborates with cross-functional teams to navigate regulatory processes, maintain documentation, and facilitate communication with regulatory agencies. Candidates must be available to work an in-person work schedule from 8:00am to 5:00pm, Monday through Friday.

Requirements

Bachelor’s degree in regulatory affairs, life sciences, pharmacy, chemistry, or related field (advanced degree preferred).
Previous experience in regulatory affairs, quality assurance, or related roles within a regulated industry.
Knowledge of regulatory requirements and guidelines applicable to the industry.
Strong analytical, research, and problem-solving skills, with attention to detail.
Excellent communication, presentation, and interpersonal skills.
Ability to work collaboratively in cross-functional teams and adapt to changing priorities.
Proficiency in regulatory software, document management systems, and Microsoft Office Suite.
Familiarity with regulatory submission formats and electronic submission requirements.
Willingness to travel occasionally for regulatory meetings, conferences, or training sessions.
Adherence to ethical standards and confidentiality requirements in handling sensitive information.

Nice To Haves

advanced degree preferred

Responsibilities

Stay abreast of regulatory developments, updates, and changes impacting the Veterinary Medicine industry.
Research and interpret relevant laws, regulations, guidelines, and standards applicable to products or processes.
Analyze regulatory requirements to assess their impact on product development, labeling, advertising, and distribution.
Prepare and submit regulatory filings, applications, notifications, and registrations to regulatory agencies.
Ensure timely completion and accuracy of regulatory documentation, including product dossiers, technical files, and quality records.
Support compliance activities, such customers and vendor due diligence.
Collaborate with internal stakeholders, Sales, Purchasing, Credit, IT, Finance, Operations and marketing teams, to integrate regulatory requirements.
Facilitate communication and interactions with regulatory agencies, including responding to inquiries, requests for information, and regulatory audits.
Develop regulatory strategies and plans to navigate complex regulatory landscapes and expedite product approvals.
Assess regulatory risks and potential compliance issues and develop mitigation strategies to address them.
Participate in risk assessments, gap analyses, and regulatory impact assessments to ensure regulatory compliance and business continuity.
Identify opportunities for process improvements and efficiency gains in regulatory processes and procedures.
Provide training and education to internal stakeholders on regulatory requirements, changes, and best practices.
Maintain proficiency in regulatory affairs through ongoing professional development, training, and participation in industry associations and forums