Regulatory Affairs Specialist - Post Approval/Life Cycle Management

Techhaul360 Consulting Services; United States; Remote; USD 90,000 - 150,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist with expertise in Post Approval Activities and Life Cycle Management. This pivotal role involves ensuring regulatory compliance for marketed products in the Canadian market, managing change controls, and collaborating with cross-functional teams. The ideal candidate will have a strong background in CMC documentation and regulatory strategies, with a focus on maintaining product approvals. Join a dynamic team dedicated to excellence in regulatory affairs and make a significant impact on product lifecycle management.

Qualifications

• 10+ years of regulatory affairs experience in Post-Approval Activities.
• Strong knowledge of Canadian post-marketed regulations.

Responsibilities

• Prepare and submit Post-Notice of Compliance submissions.
• Evaluate change controls and provide regulatory impact assessments.
• Lead post-marketing maintenance activities and ensure compliance.

Skills

Regulatory Affairs

Change Control Management

CMC Documentation

eCTD Publishing Systems

Analytical Skills

Communication Skills

Education

Masters or Ph.D. in Pharmacy

Masters or Ph.D. in Life Sciences

Masters or Ph.D. in Chemistry

Tools

Regulatory Tracking Systems

Microsoft Office Suite

Job description

Job Summary:

We are looking for a highly skilled and experienced Regulatory Affairs Specialist specializing in Post Approval Activities/Life Cycle Management for marketed products. The candidate will support regulatory compliance activities for post-approval changes related to the Canadian market (Health Canada). The role includes regulatory assessment of change controls, preparation and submission of post-approval dossiers, and active cross-functional collaboration with internal teams to maintain regulatory approvals for marketed products.

Role & responsibilities

Post-Approval Submissions:

• Prepare, review, and submit Post-Notice of Compliance (Post-NOC) submissions including Level I - Supplements (SNDS, SANDS), Level II - Notifiable Changes (SNDS, SANDS), Level III - Annual Notifications and Level IV - Record of changes.
• Manage lifecycle submissions for Health Canada (NOC Changes).
• Ensure accurate and timely filing of CMC changes, variations, and amendments in accordance with local regulatory requirements.

Change Control Management:

• Evaluate change controls (manufacturing, packaging, specification updates) from a regulatory perspective.
• Provide regulatory impact assessment and propose an appropriate action plan for each change control.
• Classify changes correctly based on Health Canada guidance (Level I, II, III, IV) and prepare corresponding submissions.

CMC (Chemistry, Manufacturing, and Controls) Expertise:

• Strong understanding of CMC requirements in the generic pharmaceutical industry (solid oral, injectable, topical dosage forms).
• Prepare and compile high-quality CMC documentation supporting lifecycle management submissions.
• Support regulatory queries from Health Authorities related to CMC sections of applications.

Regulatory Strategy and Compliance:

• Interpret and apply Health Canada Post-NOC Guidance, Food and Drug Regulations (C.08.004), and relevant ICH Guidelines (Q8, Q9, Q10, Q11).
• Develop regulatory strategies ensuring effective management of post-approval activities and ongoing product compliance.

Cross-Functional Collaboration:

• Act as a regulatory representative in cross-functional teams including Quality Assurance, Manufacturing, R&D, and Supply Chain.
• Provide regulatory advice during the planning and execution of change controls and product improvement initiatives.

Health Authority Interactions:

• Prepare responses to Health Canada Information Requests (IRs), Clarifaxes, and deficiency letters.
• Liaise directly with Health Authorities as necessary to ensure timely and compliant approvals.

Life Cycle Management Responsibilities:

• Lead post-marketing maintenance activities such as manufacturing site changes, batch size changes, composition updates, labeling updates, packaging material updates, and stability protocol amendments.
• Maintain regulatory documentation and ensure regulatory systems are updated with current post-approval data.

Preferred candidate profile:

• Excellent organizational, analytical, and communication skills.
• Hands on Experience with electronic submission (eCTD) publishing systems is preferred
• Ability to handle multiple projects simultaneously and work effectively under tight timelines.
• Proficiency with regulatory tracking systems and Microsoft Office Suite.
• Previous experience working with cross-regional regulatory teams (Canada, US, Europe).
• Previous experience working with Post Approval Activities and Life Cycle Management specifically for Canadian market and experience interacting with Health Canada.

Required Qualifications and Skills:

• Masters or Ph.D. in Pharmacy, Life Sciences, Chemistry, or related field.
• Minimum of 10 years of regulatory affairs experience in Post-Approval Activities/Life cycle management roles.
• Strong knowledge of Canadian post-marketed regulations (Post-NOC guidance, Food and Drug Regulations C.08.004).
• Proven expertise in Change Control evaluations and preparing regulatory assessments/action plans.
• Solid CMC knowledge within the generic pharmaceutical industry (Solid Oral, Injectable, Topical preferred) and query handling.
• Ability to independently evaluate changes and compile appropriate regulatory submissions.
• Familiarity with SANDS/SNDS/Level 3 submissions for Canada and other global life cycle management submissions.