Senior Regulatory Affairs Manager

Ambicare Pharmaceuticals Inc.; United States; Remote; USD 80,000 - 100,000; Full time

Job summary

An established industry player is seeking a detail-oriented Regulatory Affairs professional with a strong scientific background. This role involves participating in the preparation and submission of drug dossiers to Health Canada, ensuring compliance with regulatory requirements, and collaborating with both internal and external teams. The ideal candidate will have a solid understanding of Canadian regulatory frameworks, excellent communication skills, and the ability to manage multiple projects under pressure. If you are a self-starter with a passion for regulatory affairs and a commitment to quality, this opportunity is perfect for you.

Benefits

Remote work following Canada office hours

Flexible support during Canadian office hours

Qualifications

• 3+ years of Regulatory Affairs experience in regulated markets.
• Thorough understanding of Canadian Regulatory requirements.

Responsibilities

• Review initial dossiers and prepare gap assessments.
• Compile and submit Drugs in eCTD format to Health Canada.

Skills

Regulatory Affairs

Document Management

Project Management

Communication Skills

Attention to Detail

Ability to Work Independently

Education

Scientific University Degree (Pharmacist, Chemist, Biochemist, Chemical Engineer)

Regulatory Affairs Diploma

Tools

Microsoft Office (Word, Excel, Outlook)

eCTD Structure and Requirements

Job description

Role & responsibilities

• Participate in the review of initial dossiers, and preparation of a gap assessment
• Participate in the preparation, compilation, notification, amendment and submission of Drugs in the eCTD format to Health Canada to obtain market authorization
• Preparation and filing of Prescription, and OTC Products to Health Canada
• Ability to interpret scientific data and information
• Respond to requests from Health Canada clarification requests for submissions and compliance for existing products.
• Participate in Health Canada interactions, as required
• Ensure all HC requirements and deadlines are met as it relates to initial dossier review (GAP assessment), initial dossier submission, and dossier responses during review.
• Assist with gathering of Foreign sites documentation during the dossier review process.
• Ensure that product labelling, package inserts and product monograph are prepared with internal labelling department and are accurate and compliant to Health Canada labeling requirements
• Assist with Clinical sites protocols and documentation as needed
• Work with internal team and external oversees team to provide support as needed

Preferred candidate profile

Scientific University Degree (Pharmacist, Chemist, Biochemist, Chemical Engineer or equivalent) with at least three years of previous Regulatory Affairs experience in regulated markets such as Canada, USA or Europe. An additional RA Diploma is an asset.

• Thorough understanding of Canadian Regulatory requirements, including interpretation of the Food & Drug Act and Regulations and a working knowledge of ICH requirements.
• Extensive Knowledge of Canadian GMPs
• Applies good document management practices.
• Hands-on working knowledge of eCTD structure and requirements
• Proven track record of compiling eCTD dossiers- Modules 1 to 5
• Proficient computer skills, which would include Microsoft Office (Word, Excel, Outlook)
• Excellent communication skills (written and oral)
• Strong Project Management skills
• Superior organizational skills, with the ability to prioritize and handle multiple tasks and deadlines, works well under pressure and has a sense of urgency
• The successful Candidate will possess excellent attention to detail and have the ability to manage time and complex RA projects
• Self-starter who is able to work independently with minimal supervision. The VP RA & QA works remotely therefore open, honest, and good communication skills are very important.

Perks and benefits

• This position is based in India (Delhi based preferred)
• Will work remotely following Canada office hours from 9am to 5pm Monday to Friday
• Flexible support during Canadian office hours may be required on exceptional circumstances