Team Lead

Role & responsibilities

Hiring candidates with 6 to 12 years experience in CMC Regulatory Affairs in Pharmaceutical Industry across regulated and semi regulated regions with hands on experience into -

• Lead submissions for post approval changes, annual reports, and product renewals across regulated and semi regulated regions.
• Manage and contribute to CMC-related projects, initiatives, cross-functional special project teams and training activities, while adhering to the companys values and principles of integrity
• Initiate and maintain CMC product timelines at the direction of product lead and report status of activities and projects.
• Interact with authors/reviewers and subject matter experts with respect to delivery of CMC documents required for regulatory submissions.
• Preparing submission content plans for CMC submissions including, CMC and amendments and renewals, post‑market supplements/variations, product renewals, Module 3 baselines, and annual report/notifications.
• Interface with the regulatory operations team.
• In depth understanding of Health Authority expectations for Injectables for regulated and semi regulated regions.
• Must possess organization skills, time management skills and attention to details.
• Must possess strong communication skills, critical thinking, interpersonal skills and interpretation skills.
• Should understand business presentation and communicate descriptions of problems and solutions.

Preferred candidate profile

M Pharm, MSc or B Pharm with experience in CMC Regulatory Affairs in Pharmaceutical Industry across regulated and semi regulated regions. Working experience into sterile/ parenteral products would be an added preference.