Company: Syneos Health Ltd
Roles and Responsibilities:
Provide regulatory and technical support for assigned product development projects, including product development documents and regulatory agency submissions, implementing/managing project regulatory activities, and supporting clients and project teams.
Skills Required
- Minimum 7 years of experience in writing Module 3 (CMC)
- Must have experience of EU (CMC Authoring-Module 3)
- Good to have US, Australia, Canada, Japan, China, and Brazil market (CMC authoring)
- Sound knowledge of ICH guidelines and submission requirements of various markets such as USFDA, EMA, etc.
- Good understanding of manufacturing and all aspects related to product development
- Ability to motivate fellow team members, provide troubleshooting, and tracking deadlines and potential to act as a first- or second-degree reviewer
- Excellent communication skills
- Effective management of individual workload; Analytical capabilities, familiarity and comfort with regulatory concepts; Professional service mentality.
Location:
Gurgaon/Bangalore /Hyderabad/Homebased
Qualifications
What we’re looking for
- BS or PhD degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field. Moderate pharmaceutical/medical device related experience.
- Demonstrated experience in contributing to the preparation of regulatory submissions including, for example, IND, PMA, NDA, MAA, and CTD, including electronic submissions.
- Excellent interpersonal / communication skills including excellent written and verbal communication skills.
- Excellent customer service skills, with the ability to work both as a team member and independently.
- Good quality management skills.
- Advanced skills in Microsoft Office Applications.
- Ability to interact with staff from multiple departments and offices to establish project standards.
- Good initiative, adaptability, and pro-activity.
- Strong analytical skills, and good attention to detail.
- Ability to work concurrently on projects, each with specific instructions that may differ from project to project.
- Fluent in speaking, writing, and reading English.
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