Associate Director, US Regulatory CMC

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.