Job Details

- Develop and maintain client relationships and highlight opportunities for increased service support to the respective lead.
- Participation in regulatory processes to gain and maintain marketing authorizations for human and veterinary medicinal products (applications, renewals, variations) including medical devices, cosmetics, food supplements and herbal products with emphasis on CMC aspects.
- Support with preparation, review and compilation of CMC documents within the framework of regulatory affairs projects.
- Communicate with clients and Health Authorities in close cooperation with the respective lead.
- Support with the planning and execution of client projects in accordance with KPIs in close cooperation with the respective lead.
- General guidance (consultancy) of colleagues and clients regarding CMC Services.
- Regulatory intelligence - develop and maintain personal regulatory knowledge, apply to client projects and actively share with colleagues.
- Support with VDC strategy implementation and optimization.
- Comply with and support the maintenance of internal procedures.
- Provide operational insights to support with VDC led commercial, marketing and business development activities including proposal input in close cooperation with the respective lead.
- Support respective lead in delivery to budget with accurate and timely reporting and provide project insights to address invoicing queries.
- In agreement with Head of VDC REG providing on-site regulatory support to GCS clients.
- The employee agrees to take over other reasonable tasks that are corresponding with their abilities upon agreement with their Line Manager/Practice Area Lead/Head of VDC REG.

Skill set





- Ability to deliver on customer or internal projects / processes within daily work; ability to prioritize parallel tasks, escalate issues where appropriate and to offer solutions for appropriate counter measures.
- Ability to analyze and solve problems and to offer solutions for a given task or project. Attention to detail. High service orientation
- Structured and systematic and independent way of working; limited latitude within established set of procedures, may determine priorities with little supervision.
- Ability to train and support junior/new colleagues in daily activities; ability to lead small projects with clearly defined scope.
- Ability to manage internal and external (client) relationships on operational / day-to-day working level as well as clients team lead level.
- Valuable communication skills (written and verbally); capability to communicate issues and propose solutions. Confident appearance.
- English business fluent

Qualification:

- Bachelors degree in life sciences, pharmacy, medicine, nursing, public health, epidemiology, regulatory affairs, or a related field, or equivalent experience required.
- Certification in pharmacovigilance, drug safety preferred. Certification in regulatory affairs, clinical safety preferred. Certification in quality management, auditing preferred.

Experience:

- 4+ years of experience in pharmacovigilance, drug safety, epidemiology, risk management, scientific consulting, regulatory affairs, or a related field.

Disclaimer : This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.

📌 Senior Specialist, Client Facing Scientific Consulting (Noida)
🏢 Amerisource Bergen
📍 Noida