Advise on responses to technical questions raised by US FDA and Health Canada, or other regulatory authorities.
Responsible for submission of documents to US FDA and Health Canada, or other regulatory authorities, such as a 483 inspection response.
Evaluate classification of drug recalls, implementation of recalls.
Evaluate, advise and prepare Field Alert Reports.
Evaluate, advise and prepare Recall Reports.
Monitor resolution of situations involving compliance issues.
Participates in the enforcement of compliance of establishments and products, with current good manufacturing practices (CGMP) and other adulteration provisions of the Title 21 of the Code of Federal Regulations and Federal Food, Drug and Cosmetic Act.
Implement regulations, policy and guidance documents, as applicable.
Ensures labeling of new human drugs complies with regulatory requirements and drug approval commitments.
Ensures that the appropriate corrective action is taken when human drug products are unsafe or adulterated.
Ensures prompt reporting to regulatory authorities.
Prepare, review and submit regulatory reports such as Annual Reports and adverse event reports.
Review and approve advertising, and promotional material as per OPDP regulations.
Assess regulatory impact on change controls.
Advise on the creation of documents such as New Drug Applications, Investigational New Drug applications, supplemental applications, clinical study protocols and reports, and other documents.
Provide oversight and advice on regulatory activities for drug products with the United States Food and Drug Administration (FDA) and other regulatory authorities.
Oversee correspondence with FDA on regulatory issues, and may liaise with FDA or other regulatory authorities.
Create or review the creation of, regulatory documents such as INDs, NDAs, FDA briefing packages, and nonclinical and clinical study protocols, for all phases of drug development.
Advise and assist with filing regulatory documents.
Advise on regulatory and enforcement issues involving human drugs.
Research, stay apprised of, and implement relevant regulations, policy, and guidance documents as applicable.
Interact with management on regulatory issues
BA/BS degree in one of the life sciences, advanced degree is preferred
AS with 10-15 years’ experience in the pharmaceutical industry including 3-5 years in Regulatory
Experience working with US and Canadian regulations
Solid knowledge of the US life cycle management regulations
Experience developing and enhancing regulatory related SOPs
Experience with driving and leading projects
Experience with electronic submissions
Excellent communication skills (verbal and writing skills)
Strong leadership skills
Internal Number: RA01
About Hill Dermaceuticals, Inc.
HILL DERMACEUTICALS, Inc. is a privately-owned pharmaceutical company that develops and manufactures innovative dermatology products for children and adults. We provide unique products that enhance the treatment of difficult-to-treat diseases such as scalp psoriasis, atopic dermatitis/eczema, chronically itchy ears, melasma (of the face) and actinic keratosis (pre-cancerous skin conditions).