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Senior Associate Director Regulatory Affairs Chemistry Manufacturing and Control (CMC)

.pre {white-space: pre-wrap;} Your tasks and responsibilities

 

The primary responsibilities of this role, Senior Associate Director Regulatory Affairs Chemistry Manufacturing and Control (CMC), are to:

 

  • Develop and/or align and implement innovative product CMC regulatory strategies for all products in the US, in close collaboration with U.S. or global Regulatory Affairs (RA), Product Supply, Development sites, Marketing, and FDA (Food and Drug Administration);
  • Lead and provide regulatory CMC assessments for U.S. product development initiatives and due diligence activities, and clearly communicate recommendations to cross-functional teams and senior management;
  • Represent U.S. RA CMC on cross-functional and regulatory project teams;
  • Translate regulatory CMC strategy into clear and measurable objectives for team members and ensure that the appropriate processes are defined and followed;
  • Act as company liaison to FDA for Regulatory CMC topics and communicate results of these interactions with the organization;
  • Develop strategies to address FDA CMC requests and requirements (including Monograph Reform), present to senior management as needed and lead execution of strategy;
  • Prepare and coordinate accurate and timely CMC submissions to FDA, responsible for final content;
  • Be responsible for CMC compliance of marketed products, change management for product development, tracking of CMC changes and assessment and coordinating implementation/processing requests after FDA approvals;
  • Oversee the Prop65 process;
  • Proactively identify CMC regulatory issues/risks and design/execute mitigation plans;
  • Identify gaps in regulatory CMC, Prop 65 and/or change control processes and address them by defining and documenting new processes and training involved personnel;
  • Maintain current knowledge of CMC regulations and industry environment and provide guidance on potential and evolving trends;
  • Review and suggest possible organization reaction to new or proposed legislation;
  • Act as a company liaison to industry trade associations or other organizations;
  • Create and manage strong network with key stakeholders such as development sites, global Regulatory Affairs, Marketing, Legal, Medical, Product Supply and other personnel that facilitate collaboration;
  • Ensure that regulatory activities and outcomes are aligned with business strategies;
  • Be capable of performing these tasks with minimal to no supervision;
  • Work on assigned special projects such as contributing to Regulatory Affairs functional improvement initiatives;
  • Contribute to the preparation for Investigational New Drug (INDs) and New Drug Application (NDA); correspondence and direct interaction with FDA; and commenting on guidance and new regulations.

 

.pre {white-space: pre-wrap;} Who you are

 

Your success will be driven by your demonstration of our LIFE values.  More specifically related to this position, Bayer seeks an incumbent who possesses the following:

 

Required Qualifications:

 

  • Graduate degree in the life sciences (Ph.D., MD, PharmD., or MS) or equivalent combination of education and experience;
  • Experience to include Ph.D., M.D., or PharmD with a minimum of six years of Regulatory experience; or a Masters with a minimum of eight years of Regulatory experience, or a Bachelor's degree with at least ten years of regulatory experience;
  • Expert knowledge and extensive hands-on experience working with and shaping CMC Over the Counter (OTC) FDA regulations;
  • Proficiency multitasking in a deadline controlled and highly regulated environment;
  • Excellent communication skills, in English verbally and in writing, in order to clearly and effectively interact internally at varying levels as well as externally with health authorities and industry associations;
  • Team and customer orientation;
  • Proficiency in MS Office;
  • Proactively drive and communicate changes;
  • Results orientation;
  • Business savvy and commercial orientation;
  • Strategic orientation.

 

Preferred Qualifications:

  • Direct regulatory experience with CMC documentation preparation for INDs and NDAs;
  • Experience in leading Health Authority meetings (FDA, EMA, Health Canada and others).
.pre {white-space: pre-wrap;} Your application Bayer offers a wide variety of competitive compensation and benefits programs. If you meet the requirements of this unique opportunity, and you have the "Passion to Innovate" and the "Power to Change", we encourage you to apply now. Job postings will remain open for a minimum of ten business days and are subject to immediate closure thereafter without additional notice. To all recruitment agencies: Bayer does not accept unsolicited third party resumes.