Associate Director US Regulatory Affairs 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.

We’re doing it with energy, curiosity and sheer dedication, always learning from unique perspectives of those around us, expanding our thinking, growing our capabilities and redefining impossible’.

There are so many reasons to join us. If you’re hungry to build a varied and meaningful career in a community of brilliant and diverse minds to make a real difference, there’s only one choice.

Associate Director US Regulatory Affairs CMC

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

YOUR TASKS AND RESPONSIBILITIES

The primary responsibilities of this role, Associate Director US Regulatory Affairs CMC, are :

• Responsible for leading the CMC regulatory strategy activities for assigned US products in close cooperation with respective US RA colleagues and FDA.
• Represents US Regulatory Affairs on assigned project teams;
• Ensures US RA CMC activities are in line with US commercial and R&D objectives, and in compliance with US regulatory guidelines and legal requirements for the assigned product portfolio and actively drives all key CMC regulatory decisions for assigned US projects;
• Develops CMC submission materials for INDs and NDAs and leads the submission activities for post-approval CMC changes;
• Proactively identifies regulatory or related risks / issues and develops mitigation and / or contingency plans;
• Organizes and leads preparations for CMC related FDA meetings / interactions and acts as the primary FDA contact for all CMC interactions on assigned projects;
• Manage virtual and / or cross functional, multidisciplinary teams; and drives alignment of US RA activities (internal and outsourced activities).
• Represents US RA on project teams;
• Participates in ad hoc or special projects that continuously improve or otherwise advance Regulatory Affairs activities;

WHO YOU ARE

Bayer seeks an incumbent who possesses the following :

Required Qualifications :

• A Bachelor’s degree in life science or related field is required;
• US FDA regulatory experience which includes CMC experience, required;
• In-depth knowledge of the US regulatory environment and the process of drug development, including aspects of pharmaceutical development (e.
• g. formulations, analytics etc.) as well as ICH guidance related to CMC;
• Ability to work collaboratively and influence without authority;
• Strong knowledge of the drug development process, FDA regulations policies with a focus on CMC;
• Strong knowledge of the drug / device development process;
• Project management skills, including attention to detail, with the ability to focus on multiple issues at one time under time pressure;
• Ability to manage significant ambiguity and effectively and proactively steer and solve diverse and complex business and regulatory issues;
• Strong ability to communicate in both oral and written English, with proven persuasive and assertive negotiating skills.

Preferred Qualifications :

• Graduate degree (PhD, PharmD, or M.S.) preferred;
• At least 4 years of pharmaceutical industry experience, preferred;
• CMC experience in the area of biologics is preferable.

LI-US