# Regulatory Manager (labelling)

**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--labelling-_25113495?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_9799d7a1-6b8

## Description

Syneos Health is seeking a Regulatory Manager (labelling) to join their team.

The Regulatory Manager (labelling) will be responsible for managing labelling updates, ensuring compliance with regulatory requirements, and collaborating with cross-functional teams.

Key responsibilities include:

- Managing end-to-end CCDS updates based on confirmed safety signals

- Leading cross-functional discussions and CCDS approval via Safety review committees

- Updating CCDS based on clinical and non-clinical study results

- Managing EU QRD's for MRP/DCP/CP and USPI's for Safety submissions

- Handling PSUSA/PRAC and linguistic reviews

- Driving labelling updates for ROW markets and artwork implementations

- Collaborating with regional teams and QP release sites

- Handling Health Authority mandated Safety proposals and deviations

The successful candidate will have:

- A minimum of 8 years of relevant experience

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

- Comprehensive regulatory knowledge and understanding of pharmaceutical and/or medical device product development

- Excellent interpersonal and communication skills

- Good quality management and budgeting skills

- Good people management, project management, problem-solving, and decision-making skills

- Advanced skills in Microsoft Office Applications

- Fluency in English

Syneos Health 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
- regulatory affairs
- labelling
- pharmaceuticals
- medical devices
- Microsoft Office

### Nice to have
- PSUSA/PRAC
- linguistic reviews
- ROW market labelling

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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--labelling-_25113495?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)