CMC Regulatory Consultant, Biologics
Employment Information
Report this job
Job expired or something wrong with this job?
Job Description
CMC Regulatory Consultant supporting biologic and rare-disease product submissions to Health Canada. Managing Canadian life-cycle regulatory activities, CMC authoring, and regulatory intelligence for Syneos Health clients.
Responsibilities:
- Support client submissions to Health Canada for a biologic/small molecule rare disease product portfolio
- Prepare and support Level III submissions
- Support sNDS submissions, including updating local Module 3 documents
- Support PQRs and Annual Drug Notifications
- Coordinate Clarifax responses
- Interact directly with Health Canada
- Provide local Canada regulatory intelligence
- Work self-sufficiently on life-cycle submissions in Canada
Requirements:
- Biologics experience required
- Experience supporting submissions to Health Canada for biologic/small molecule rare disease products
- Essential experience with life-cycle management submissions, including Level III submissions, sNDS submissions, local Module 3 document updates, PQRs, Annual Drug Notifications, and coordinating Clarifax responses
- Direct interaction experience with Health Canada required
- CMC authoring experience required
- Ability to provide local Canada regulatory intelligence
- Ability to work self-sufficiently in supporting life-cycle submissions in Canada
- Equivalent experience, skills, and/or education may be considered
Benefits:
- Career development and progression
- Supportive and engaged line management
- Technical and therapeutic area training
- Peer recognition
- Total rewards program
- Inclusive culture
- Reasonable accommodations, when appropriate, for employees or applicants with disabilities
Similar Jobs
Regulatory Specialist – Canada
Local Regulatory specialist supporting Health Canada lifecycle submissions for biologic and small molecule rare disease products. Providing Canadian regulatory intelligence and coordinating Health Canada interactions.
Senior DOT Compliance Instructor
Senior DOT compliance instructor training commercial drivers and overseeing fleet compliance for SOLV Energy’s utility-scale energy infrastructure projects. Fully remote with 70–80% travel to field locations.
Senior Regulatory Affairs Program Lead – MedTech Surgery
Regulatory Affairs Lead advancing Johnson & Johnson’s OTTAVA robotic instruments and accessories approvals. Developing global strategies, authoring FDA submissions, and guiding product teams.
Senior Regulatory Affairs Specialist
Senior Regulatory Affairs Specialist advancing regulatory strategy for Eko Health’s FDA-cleared AI stethoscopes, ECG hardware, and digital health platforms. Leading QMS remediation and global market submissions.
Senior Compliance Analyst
Senior Compliance Analyst investigating escalated Medicare Advantage sales and marketing compliance cases for Devoted Health. Recommending corrective actions, improving workflows, and supporting compliance analysts.
Senior Compliance Analyst – Healthcare Regulatory Compliance
Senior Compliance Analyst safeguarding Cuvo Health’s telehealth MSO infrastructure across US healthcare regulations. Auditing physician arrangements, FMV compensation, licensing, and multi-state compliance.
Senior Regional Compliance Officer
Senior Compliance Officer overseeing MoneyGram agent AML/CFT and anti-fraud compliance across Australia and New Zealand. Acting as Deputy Compliance Officer and liaising with regulators and law enforcement.
VP, Policy and Regulatory Strategy
VP leading Circle’s Latin American policy, licensing, and regulatory strategy. Shaping market expansion for digital-asset payments and blockchain financial infrastructure.
Government Compliance Technical Specialist
Government compliance specialist advancing FedRAMP, TX-RAMP, and IRAP programs for BeyondTrust’s identity security SaaS. Automating evidence collection and managing cloud compliance documentation and remediation.
Regulatory Consultant – Submission Manager, Veeva RIM
Regulatory Consultant managing Veeva Vault RIM submission plans and regulatory publishing for Syneos Health’s life sciences clients. Supporting Vertex submission managers with project tracking and coordination.
Senior Director, Regulatory CMC
Senior Director leading global CMC regulatory strategy for Summit Therapeutics, a biopharmaceutical oncology company. Overseeing biologics submissions, Health Authority interactions, and lifecycle compliance.
Manager, Regulatory Registration and Compliance
Regulatory compliance manager leading pharmaceutical submissions and complex regulatory projects at PrimeVigilance. Guiding clients and teams across global pharmacovigilance and patient-safety programs.
Director of Compliance
Director of Compliance leading hospice regulatory oversight, audits, investigations, and corrective actions. Supporting Ennoble Care’s mobile primary, palliative, and hospice services.
Senior Security Governance, Risk & Compliance Specialist
Senior Security GRC Specialist strengthening Clario’s information security governance, risk, and compliance programs. Coordinating audits, assessments, third-party risk, controls, and security frameworks.
Director, Regulatory Affairs – Americas
Leading Americas regulatory strategy for HOYA Vision Care, a global vision-care and optical technology company. Driving medical-device submissions, compliance, and regulatory operations across regional markets.
Associate Director, Carrier Compliance
Associate Director leading Medicare Advantage carrier compliance, sales oversight, and remediation for Humana’s healthcare business. Managing compliance professionals and carrier relationships nationwide.
PCI Compliance Specialist, Spanish
PCI compliance specialist supporting customers through VikingCloud’s cybersecurity and compliance platform. Resolving inquiries across phone, chat, email, and ticketing channels.
Compliance Officer
Compliance Officer building AML/KYC operations and EU benchmark licensing readiness for Pyth Network’s institutional data solutions. Managing financial controls, audits, policies, and counterparty risk.
Fraud Compliance Manager
Fraud Compliance Manager overseeing fraud regulations, controls and assurance at digital bank Monzo. Delivering data-led reviews, challenge and remediation across financial crime compliance.
Advisory, Risk & Regulatory, Enterprise Technology Solutions – SAP
SAP risk and regulatory consultant delivering control testing, security, and assurance services. Supporting GRC, ITGC, SOX readiness, and SAP implementation reviews.