Generative Artificial Intelligence

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., * 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., Associate Director, Regulatory Liaison - Oncology Merck & Co., Inc Rahway, NJOn-Site Biology Planning Oncology Research Marketing Chemistry Operations Management Innovation Compassion Pediatrics Communication Collaboration Pharmaceuticals Detail Oriented Drug Development Telephone Skills Clinical Research Analytical Skills Regulatory Affairs Scientific Studies Process Improvement Regulatory Sciences Contingent Workforce Lifecycle Management Strategy Development Regulatory Compliance Organizational Skills Packaging And Labeling Competitive Intelligence Communications Protocols Cross-Functional Coordination +0 Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co., Inc Rahway, NJOn-Site Writing Biology ChatGPT Inhaler Research Injector Marketing Brochures Leadership Management Innovation Compassion Pediatrics Negotiation Orphan Drugs Communication Due Diligence Telecommuting Pharmaceuticals Document Review Large Molecules Drug Development Global Marketing Telephone Skills Growth Mindedness Internal Medicine Biopharmaceuticals Regulatory Affairs Process Improvement Contingent Workforce In Vitro Diagnostics Strategy Development Regulatory Oversight Regulatory Compliance International Finance Regulatory Management Packaging And Labeling Clinical Study Reports Intellectual Curiosity New Product Development Verbal Communication Skills Generative Artificial Intelligence Applications Of Artificial Intelligence Non-Disclosure Agreement (Intellectual Property Law) +0 Senior Director Regulatory Affairs Liaison- General Medicine Merck & Co., Inc Rahway, NJ*On-Site Writing Biology ChatGPT Inhaler Research Injector Marketing Brochures Leadership Management Innovation Compassion Pediatrics Negotiation Orphan Drugs Communication Due Diligence Telecommuting Pharmaceuticals Document Review Large Molecules Drug Development Global Marketing Telephone Skills Growth Mindedness Internal Medicine Biopharmaceuticals Regulatory Affairs Process Improvement Contingent Workforce In Vitro Diagnostics Strategy Development Regulatory Oversight Regulatory Compliance International Finance Regulatory Management Packaging And Labeling Clinical Study Reports Intellectual Curiosity New Product Development Verbal Communication Skills

Planning Oncology, Research Marketing Chemistry Operations Management Innovation Compassion Pediatrics Communication Collaboration Pharmaceuticals Detail Oriented Drug Development Telephone Skills Clinical Research Analytical Skills Regulatory Affairs Scientific Studies Process Improvement Regulatory Sciences Contingent Workforce Lifecycle Management Strategy Development Regulatory Compliance Organizational Skills Packaging And Labeling Competitive Intelligence Communications Protocols Cross-Functional Coordination, * M.D. or Ph.D. or other related doctoral degree in biological science, chemistry or related discipline

• Master's Degree with at least 2 years of relevant experience in pharmaceutical industry
• Bachelor's Degree, with at least 5 years of relevant experience in the pharmaceutical industry

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

Required Skills: Biological Sciences, Clinical Research, Cross-Functional Teamwork, Drug Development, Facilitated Communication, Protocol Review, Regulatory Affairs Management, Regulatory Communications, Regulatory Compliance, Regulatory Strategy Development, Regulatory Submissions, Scientific Research, Strategic Thinking

Preferred Skills: Oncology

We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.

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The salary range for this role is $142,400.00 - $224,100.00

Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.