Company Overview:
Minerva Research Solutions is a clinical trial management service provider.We aim to transform the landscape of healthcare and research with our quality clinical services. We support the biotech, medical, and pharma industries through all phases of the clinical trial lifecycle. Our services include Data Operation, Recruitment Services, and Regulatory. Our goal is to speed up the lifecycle of novel therapies through streamlined processes, stringent timelines & real-time solutions. Our clinical trial support services & consultations are tailored to foster your product and requirements. We aim to deliver high-quality data and solutions to make your clinical trials a success. We follow stringent FDA and GCP regulations throughout all phases of the clinical trial process.
Job Purpose:
The Coordinator - Regulatory Affairs is responsible for working as a team member of regulatory professionals in ensuring regulatory compliance of company products and activities, including the preparation and submission of regulatory documents, the management of regulatory inspections, and the development and implementation of regulatory strategies.
Key Responsibilities:
- Working as a regulatory professionalto ensure effective and efficient regulatory support for the company's products and activities.
- Develop and implement regulatory strategies that support the company's business objectives and ensure compliance with relevant regulations and guidelines.
- Manage the preparation and submission of regulatory documents, including regulatory filings, registrations, and certifications.
- Coordinate and manage regulatory inspections and audits, and ensure appropriate corrective and preventive actions are taken in response to any findings.
- Keep abreast of changes in regulatory requirements and guidelines, and communicate these changes to relevant stakeholders in a timely manner.
- Build and maintain positive relationships with regulatory authorities and other external stakeholders.
- Provide regulatory guidance and support to cross-functional teams, including product development, clinical research, manufacturing, and quality assurance.
- Collaborate with internal and external stakeholders to develop and implement regulatory policies and procedures that support the company's overall goals and objectives.
- Ensure timely and accurate reporting of regulatory activities and metrics.
Qualifications:
- Bachelor's degree in a scientific discipline, preferably in life sciences, chemistry, or pharmacy.
- 01 years of experience in regulatory affairs, fresh graduates will also be preferred
- In-depth knowledge of global regulatory requirements and guidelines for pharmaceuticals, medical devices, or other regulated products.
- Excellent communication, interpersonal, and problem-solving skills.
- Ability to work independently and manage multiple projects simultaneously.
- Strong attention to detail and accuracy.
- Experience working in a fast-paced, deadline-driven environment.
Benefits:
- Competitive salary and performance-based bonuses.
- Medical health insurance coverage.
- Employees Old-age benefits coverage.
- Professional learning and developmentsupport.
- Generous vacation and paid time off.
- Employee assistance programs for mental health.
- Company-sponsored events and team-building activities.
- Diverse, professional, and inclusive work environment.
- Opportunities for career growth.
- Cutting-edge technology and tools.
- Family-friendly policies, including parental leave.
- Commuter benefits or transportation assistance.
- Social responsibility and community involvement programs.
Openings:
04 positions
Full-time
On-site job
Work Schedule Timings:
Monday to Friday
Evening Shift (07 PM to 03 AM)
(transport facility provided for female staff only and allowance for male employees, additional night shift allowance)
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