# Regulatory Manager (CMC and Biologics)

**Company**: Syneos Health
**Location**: IND-Hyderabad-Hybrid
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Category**: Healthcare
**Industry**: Healthcare

**Apply**: https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Hyderabad-Hybrid/Regulatory-Manager--CMC-and-Biologics-_25113207?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_0bface27-c99

## Description

Syneos Health is seeking a Regulatory Manager (CMC and Biologics) to join their team. The successful candidate will have a minimum of 10+ years of experience in Biologics and CMC, with strong expertise in Regulatory Intelligence across various global markets.

**Job Responsibilities** The Regulatory Manager will contribute to planning for regulatory submissions in assigned region/country/project, and will be responsible for day-to-day management of project teams and projects. The successful candidate will have line management responsibilities for staff members, and will participate in department staff operations such as interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.

The Regulatory Manager will also act as a representative of the regulatory department with other departments, support business development, and develop, review, and monitor project budgets. The successful candidate will have excellent interpersonal and communication skills, including excellent written and verbal communication skills, and will be able to work both as a team member and independently.

**Qualification Requirements** The successful candidate will have a BS degree, preferably in a science-related field or equivalent experience in science/regulatory/medical writing-related field or moderate pharmaceutical/medical device related experience. The Regulatory Manager will have demonstrated experience in contributing to the preparation of regulatory submissions, comprehensive regulatory knowledge and understanding of pharmaceutical and or medical device product development, and excellent customer service skills.

**Additional Information** The company offers a range of benefits, including career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards program. The company is committed to building an inclusive culture, where employees can authentically be themselves.

## Skills

### Required
- Biologics
- CMC
- Regulatory Intelligence
- Module 3 authoring
- dossier preparation
- regulatory submission strategies
- compliance requirements
- product lifecycle management

### Nice to have
- Small Molecules
- Biosimilars
- GRAS

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Source: [Apply at syneoshealth.wd12.myworkdayjobs.com](https://syneoshealth.wd12.myworkdayjobs.com/en-US/Syneos_Health_External_Site/job/IND-Hyderabad-Hybrid/Regulatory-Manager--CMC-and-Biologics-_25113207?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)