Ensures that pharmaceuticals, medical devices, and related products comply with all relevant regulations, laws, and guidelines. This role involves managing the registration process, ensuring compliance with regulatory agencies like the FDA, and providing expertise on regulatory matters. Regulatory Pharmacists work to maintain compliance, address any issues, and provide input on regulatory strategies.
Key Responsibilities:
Regulatory Submissions:
Preparing, submitting, and following up on regulatory documents for drug approval, registration, and post-approval activities.
Compliance:
Ensuring that all aspects of product development, manufacturing, and distribution adhere to regulations.
Communication:
Liaising with regulatory agencies, internal teams, and external stakeholders to address regulatory issues.
Strategy:
Developing and implementing regulatory strategies to ensure compliance and facilitate product development.
Post-Approval Surveillance:
Monitoring product safety, managing post-approval changes, and ensuring ongoing compliance.
Audits and Inspections:
Participating in internal audits and regulatory inspections.
Policy and Procedure Development:
Creating and implementing regulatory policies, procedures, and training programs.
Qualifications and Skills:
Education: Bachelor's degree in Pharmacy or a related field.
Licensure: Valid Professional Regulation Commission (PRC) license (or equivalent in the relevant country).
Experience: Experience in pharmaceutical warehousing, distribution, or regulatory affairs is preferred.
Knowledge: Strong understanding of pharmaceutical regulations, guidelines, and standards set by regulatory agencies.
Skills: Excellent communication, interpersonal, and problem-solving skills.
Other: Attention to detail, ability to multi-task, and ability to work independently.