Associate Director Regulatory Liaison - Oncology

The Associate Director, Regulatory Affairs, supports products in the Oncology therapeutic area as part of a regulatory team.  The individual will have excellent communication and collaboration skills and will work closely with a global regulatory lead(s) to help develop and implement a global strategy for registration and/or maintenance of products. 

Responsibilities may encompass all aspects of planning and implementation of a global regulatory strategy and regulatory submissions including assisting in preparing submissions, protocol review, and conducting research on regulatory guidance's or competitive intelligence.  The individual will have responsibility for driving results for his/her assigned projects through application of regulatory science and strong communication and analytical skills.   

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Primary Responsibilities:

• Assisting in Regulatory Agency communications and submissions, including marketing applications, investigational new drug (IND) applications, pediatric plans and annual or other periodic reports. The individual may also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests.
• Implementing strategy to develop Agency background packages and documents associated with regulatory submissions for marketing applications.
• Communicating with Agencies and attending Agency meetings as needed to assist the global regulatory lead.
• Participating as an active member on the global regulatory team.  Individual will attend cross-functional meetings as required, in collaboration with, and to assist the global regulatory lead.
• Conducting research and review of guidelines, regulatory precedence and competitive intelligence to facilitate development of regulatory strategy.  Assist the global regulatory lead in authoring of regulatory strategy documents.
• Collaborating and communicating regulatory strategy as needed to colleagues in Regulatory Operations, Clinical Safety, Labeling, Regulatory Chemistry, Manufacturing and Control (CMC) as well as other functional areas (e.g., clinical research, non-clinical safety assessment).
• Support maintenance (e.g., quality compliance and life cycle management) of oncology programs.
• Support of global regulatory lead in label development.
• Assisting with process improvement initiative.
• Performing regulatory administrative activities, as needed.

Education Minimum Requirements:

• Bachelor’s Degree, with at least 5 years of relevant experience in the pharmaceutical industry.
• Master’s Degree with at least 2 years of relevant experience in pharmaceutical industry.
• M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline with relevant experience.

Required Experience and Skills:

• Experience in drug development
• Prior regulatory experience interacting with a major regulatory agency
  Excellent communication skills (both oral and written).
• Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects.
• Flexibility required.
• Strong scientific and analytical skills with attention to detail.

Preferred Experience and Skills:

• Experience with oncology products is highly preferred

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The salary range for this role is

This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs.

The successful candidate will be eligible for annual bonus and long-term incentive, if applicable.

We offer a comprehensive package of benefits.  Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits.

You can apply for this role through https://jobs.merck.com/us/en (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.