# Sr Regulatory Consultant (CMC, EU mkt)

**Company**: Syneos Health
**Work arrangement**: onsite
**Experience**: senior
**Job type**: full-time
**Category**: Consulting
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Gurugram-Hybrid/Sr-Regulatory-Consultant--CMC--EU-mkt---Office-based-_25112917?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_f03fb05a-c34

## Description

Syneos Health is seeking a Sr Regulatory Consultant (CMC, EU mkt) to join their team.

The successful candidate will have 6-9 years of Regulatory Affairs experience, preferably in biologics, with strong expertise in authoring and reviewing Module 3 CMC sections for post-approval variations and lifecycle activities.

Key responsibilities include:

- Contributing to project teams and projects on a day-to-day basis

- Acting as a representative of the GRAS regulatory department with other departments

- Providing technical expertise to proposals and assisting with Business Development initiatives

- Understanding project budgets, scope of projects, allocated hours, and tracking compliance

- Interacting with internal and external personnel, clients, and technical experts on projects

- Conducting regulatory research on projects as needed

- Preparing consulting reports under guidance

- Arranging, leading, and reporting on client meetings

- Contributing to regulatory agency meetings

- Writing IND and product registration dossiers, clinical reports, and other regulatory documents for submissions

- Preparing full regulatory submissions for INDs, product registrations, and post-approval maintenance activities

- Acting as a resource for technical knowledge

- Participating in quality improvement efforts to increase overall operational efficiency

- Contributing to the building of the regulatory systems and infrastructure needed for GRAS

- Developing a reputation for the Company as an industry leader in Regulatory

- Providing internal training in appropriate areas of expertise to other Departments

The ideal candidate will have:

- A BS degree, preferably in a science-related field or equivalent experience

- Moderate regulatory, pharmaceutical/medical device related experience

- Demonstrated experience in contributing to the preparation of regulatory submissions

- Excellent interpersonal and communication skills

- Excellent customer service skills

- Good quality management skills

- Problem-solving and decision-making skills

- Advanced skills in Microsoft Office Applications

- Ability to interact with staff from multiple departments and offices

- Good initiative, adaptability, and pro-activity

- Strong analytical skills and attention to detail

- Ability to work concurrently on projects

- Fluent in speaking, writing, and reading English

## Skills

### Required
- Regulatory Affairs
- Biologics
- CMC
- Module 3
- EU market
- English

### Nice to have
- PhD
- OOD
- PIP/PMP

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Gurugram-Hybrid/Sr-Regulatory-Consultant--CMC--EU-mkt---Office-based-_25112917?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)