Senior Associate Director Regulatory Affairs Strategy Allergy

Whippany, NJ, United States
Apr 17, 2018
Required Education
Position Type
Full time
Your tasks and responsibilities

The primary responsibilities of this role, Senior Associate Director RA Strategy Allergy, are to:

  • Develop, align and implement innovative global regulatory strategies and timelines for assigned projects and ensure proper and timely new product registration in identified countries;
  • Translate regulatory strategy into clear and measurable objectives and ensure that appropriate processes are defined and followed;
  • Manage preparation of registration dossiers related to assigned products;
  • Ensure that product dossiers are properly maintained and accessible;
  • Ensure that all registration data are entered into the proper data management systems;
  • Provide support to local affiliates with strategy formulation and registration requirements for assigned products;
  • Interact with Health Authorities, as appropriate;
  • Lead and/or participate in cross-functional teams and regulatory project teams;
  • Proactively identify and track regulatory activities and/or issues and risks and design/execute mitigation plans;
  • Identify gaps in regulatory processes and address them by defining and documenting new processes and training involved personnel;
  • Liaise with Drug Safety and Medical to assist local countries in substantiating claims;
  • As assigned by I&D Unit Regulatory Strategy Lead, provide regulatory expertise to and oversee work of staff supporting assigned products/projects;
  • Maintain current knowledge of 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 company liaison to industry trade associations;
  • Regularly report status measures to Regulatory Strategy Management and appropriate stakeholders;
  • Lead Regulatory due diligence activities for area of responsibility;
  • Create and manage strong network with key stakeholders such as GCBU, and other scientific personnel that facilitate collaboration;
  • Ensure that regulatory activities and outcomes are aligned with business strategies;
  • Lead special projects, such as Regulatory Affairs functional improvement initiatives.

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:
  • Ph.D, M.D. or Pharm.D with a minimum of 6 years Regulatory experience; or Master's degree with minimum of 8 years of Regulatory experience; or Bachelor's degree with minimum of 10 years of Regulatory experience;
  • Expert knowledge and extensive hands on experience of US and/or European regulatory procedures ( Mutual Recognition, Decentralized and National) and 4 years of hands-on experience working with OTC requirements preferred;
  • Proficiency in multi-tasking in deadline controlled and highly regulated environment;
  • Excellent communication skills, in English, verbally and in writing are required in order to clearly and effectively interact internally at varying levels as well as externally with Health Authorities and industry associations;
  • Proficiency in MS Office;

Preferred Qualifications:
  • Proactively drive and communicate changes;
  • Results orientation;
  • Successful track record in contributing to/managing cross-functional teams;
  • Business savvy and commercial orientation;
  • Strategic orientation;
  • Able to perform all responsibilities with minimal to no supervision;
  • Team and customer orientation.


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.

Bayer is an Equal Opportunity Employer/Disabled/Veterans

Bayer is committed to providing access and reasonable accommodations in its application process for individuals with disabilities and encourages applicants with disabilities to request any needed accommodation(s) using the contact information below.

Country: United States
Location: NJ-Whippany