No C2C please!

Responsibilities:

• Well versed in performing CMC compliance activities including Gap Analysis; assessment for Annex 3 comparative table with reference EU Member States
• Manage execution / authoring and review of CMC documentation (Module 1 , 2 and 3 / Part II ) for life cycle management - post-approval supplements, baseline dossiers, annual reports, registration renewals, response to health authority questions, assessment reports and Expert reports
• Experience in reviewing of CMC quality documents like Product development report, process validation, method validation, stability data, finished product specification as per guideline.
• Knowledge on relevant regulatory guidelines VICH guideline, USP, EU, ICH guidelines and relevant applications.
• Ph. Eur requirements for veterinary products and guidance (not limited to QRD veterinary template, guideline on SPCs for antimicrobials, MRL etc.)
• Lead development and execution of global product and project regulatory, strategy(ies) for assigned Veterinary products in accordance with global regulations and guidance.
• Review of artworks / labelling, SmPC and pack insert.
• Comparison of CPCs (Critical Pharmaceutical Characteristics), Prepare and submit a proposal of a harmonised SPC.
• Evaluation and Assessment of change control and develop a plan with timeline to implement the same.
• Knowledge and experience on reviewing the DMF and assessment of Drug substance related changes, gap analysis and authoring of corresponding variation packages.
• Hands on experience on authoring CMC documentation for worldwide marketing of Veterinary products for initial registration and life-cycle management.
• Planning the project by understanding the client needs, managing project deliverables and providing solutions in real time.
• Work with cross-functional teams to track and follow up outstanding documentation, coordinate on project status & reporting to stakeholders
• Deliver all regulatory milestones as per agreed SLAs with clients
• Identify, communicate and escalate potential regulatory issues / risks and propose mitigation.

Qualifications we seek in you!

• Experience should be 4 to 7 years
• Bachelor's or master’s degree required in science, engineering or related field (advanced degree preferred).
• Proven and relevant regulatory affairs experience in pharmaceutical, vaccine, or biological products; or related fields
• Knowledge and hands on experience on Animal Health CMC
• Marketing authorization experience.
• Proven Project Management experience

Job Types: Part-time, Contract

Pay: $40.00 per hour

Expected hours: 40 per week

Experience level:

• 7 years

Schedule:

• 8 hour shift
• Day shift
• Monday to Friday

Experience:

• Animal Health CMC: 6 years (Required)
• CMC Module ( 1,2, 3): 7 years (Required)
• Project Management: 6 years (Required)

Work Location: In person