Lead Regulatory Affairs Specialist

Job Description Position Summary The Regulatory Affairs Specialist will be responsible for managing regulatory activities for biosimilar products for the emerging market, with a strong focus on LATAM region. This role involves ensuring compliance with regional regulations, supporting product lifecycle management, and leading submissions for primary filings...

Job Description Job Title: Regulatory Affairs Specialist Med/Pharma (Female) Location: Remote Position Overview: We are seeking an experienced Regulatory Affairs professional with expertise in both pharmaceutical and medical device regulatory compliance. The role involves preparing, reviewing, and submitting regulatory documentation to global health...

Job Description This role is for one of our clients Industry: Administrative and Support Services Seniority level: Mid-Senior level Min Experience: 3 years Location: India, Hyderabad JobType: full-time We are seeking a detail-oriented and proactive Regulatory Affairs Specialist to join our team. This role will be responsible for preparing, compiling,...

Job Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej CrossroadsDepartment: RAReports To: RA Head and Regulatory Department at HO /DirectorEmployment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half DayPreferred Gender : M/FExperience: Minimum 2 yearsJob Summary:We are seeking a proactive and...

Lead Specialist, Regulatory Affairs Job Description SummaryIn this role you will be focused on obtaining and maintaining global third-party supplier documentation for Imaging Accessories& Supplies (A&S) products. Under the instruction from A&S Product RA ensuring documentation requirements are obtained in accordance with the supplier contract for initial...

Job Title: Regulatory Affairs Junior ManagerLocation: At Ahmedabad Office , Near Thaltej CrossroadsDepartment: RAReports To: RA Head and Regulatory Department at HO /DirectorEmployment Type: Full TimeOffice hours : 9,30 AM to 6 PMWeek of: Sunday and Saturday Half DayPreferred Gender : M/FExperience: Minimum 2 yearsJob Summary:We are seeking a proactive and...

Job Description About Us: Concept Medical is at the forefront of developing and manufacturing innovative medical devices for interventional cardiology and radiology. Our commitment to excellence in healthcare and patient outcomes drives us to provide the best-in-class stents and balloon catheters. With a growing presence in the global market, we are...

Job Description - Drive regulatory strategy with global impact at a leading healthtech innovator - Leadership role with strong visibility and growth potential Job Description 1. Regulatory Strategy Development- Define and drive the regulatory vision and strategy for CRM products, aligning with company's business goals. 2. Leadership and Team Management-...

Key Responsibilities:- Lead and manage CMC regulatory activities for USFDA submissions including ANDA preparation, review, and filing.- Oversee compilation and submission of Annual Reports, amendments, and deficiency responses.- Interface with cross-functional teams including Quality Assurance, Production, and R&D to gather required documentation and data.-...

Job Description We are seeking a detail-oriented and proactive Regulatory Affairs Associate to join our Global Regulatory team. In this role, you will be responsible for development and execution of CMC regulatory strategies, marketing applications and Life Cycle Management for biosimilar products. RESPONSIBILITIES: Plan and manage development of high...