# Associate Director, US Regulatory CMC

**Company**: Pharmaceuticals
**Location**: Whippany, New Jersey
**Work arrangement**: hybrid
**Experience**: senior
**Job type**: full-time
**Salary**: $139,800 to $209,700
**Category**: Regulatory Affairs
**Industry**: Healthcare

**Apply**: https://talent.bayer.com/careers/job/562949978556861?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply
**Canonical**: https://yubhub.co/jobs/job_572c539e-5f6

## Description

At Bayer we're visionaries, driven to solve the world's toughest challenges and striving for a world where 'Health for all Hunger for none' is no longer a dream, but a real possibility.

The Associate Director US Regulatory Affairs CMC is responsible for creation and implementation of CMC regulatory strategies to support Bayer's development and marketed product portfolios.

**Responsibilities:**

- Leading CMC regulatory strategy activities for assigned US products in close cooperation with respective US RA colleagues and FDA.

- Ensuring US RA CMC activities are in line with US commercial and R&D objectives, and in compliance with US regulatory guidelines and legal requirements.

- Developing CMC submission materials for INDs and NDAs and leading submission activities for post-approval CMC changes.

- Identifying regulatory or related risks/issues and developing mitigation and/or contingency plans.

- Organizing and leading preparations for CMC related FDA meetings/interactions.

- Managing virtual and/or cross-functional, multidisciplinary teams.

**Requirements:**

- Bachelor's degree in life science or related field.

- US FDA regulatory experience which includes CMC experience.

- In-depth knowledge of the US regulatory environment and the process of drug development.

- Ability to work collaboratively and influence without authority.

- Strong knowledge of the drug development process, FDA regulations policies with a focus on CMC.

- Project management skills, including attention to detail, with the ability to focus on multiple issues at one time under time pressure.

**Preferred Qualifications:**

- Graduate degree (PhD, PharmD, or M.S.).

- At least 4 years of pharmaceutical industry experience.

**Benefits:**

- Salary of between $139,800 to $209,700.

- Additional compensation may include a bonus or commission.

- Health care, vision, dental, retirement, PTO, sick leave, etc.

## Skills

### Required
- CMC regulatory strategy
- US FDA regulatory experience
- drug development process
- project management
- regulatory guidelines

### Nice to have
- graduate degree
- pharmaceutical industry experience

---

Source: [Apply at talent.bayer.com](https://talent.bayer.com/careers/job/562949978556861?utm_source=yubhub.co&utm_medium=jobs_feed&utm_campaign=apply)