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Director - CMC Regulatory Affairs (Drug Device Combination P

at Merck in Dover, Delaware, United States

Job Description

Job Description

Attention NJ Applicants : In April 2020, our Company announced plans to consolidate our New Jersey campuses into a single New Jersey headquarters location in Rahway, NJ by 2023. Therefore, the NJ work location for this role will be temporarily based and the exact timing of the departmental move to Rahway, NJ will be communicated at a future date.

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

This Principal Scientist position is equivalent to a Director position. Under direction from Executive Director, the Principal Scientist is responsible for implementing Devices and Drug-Device Combinations (DDDC) regulatory strategies for our organization in accordance with domestic and international regulations and guidance. The Principal Scientist is responsible for the preparation and submission of combination product sections for commercial or new products such as pre-filled syringes and autoinjectors. The Principal Scientist will lead the development and the implementation of regulatory strategies for their assigned projects and provide mentoring and coaching as required.

Responsibilities include but are not limited to:

· Serve as a Regulatory Project Lead and provide Regulatory leadership within Regulatory and on cross-functional teams for the assigned device and combination products in development or commercial products

· Maintain in depth knowledge of global device and drug/biologic-device combination product guidelines regarding IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE marking and responses to health authority questions per established business processes and systems

· Lead the development, communication, and review of the Regulatory Strategy Document for projects of increasing complexity

· Resolve complex project issues through collaboration with the team and cross functional partners and provide recommendations to Regulatory leadership team as appropriate.

· Collaborate with Device Development, Device Quality and other stakeholders to communicate and align on new regulations and requirements to ensure internal procedures and processes are compliant

· Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal

· Support new technology development within our Company.

· May need to manage or mentor junior team members

· Develop regulatory strategies, for drug/biologic-device combination products for clinical, marketing application and post-approval changes

· Development, communicate, implement and maintain detailed, global regulatory strategies for submission and approval of complex INDs, BLAs original NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE marking and responses to health authority questions according to defined timelines

· Lead authoring of clear, concise and effective INDs, BLAs original NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE marking according to defined timelines

· Provide detailed, global regulatory assessments for changes to medical device and drug-device combination products according to existing global guidelines and policies and determine and communicate the regulatory reporting requirements

· Support device design control activities and documentation reviews

· Provide evaluations of regulatory state of affairs of any devices and combination products, for due diligence of potential suppliers, partners, or acquisitions

· Assess global device and combination product regulatory intelligence and assist in the development of device and combination product regulatory strategies

· Participate in activities and teams related to device and combination products

· Anticipate device related regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions

· Careful planning, tracking and communicating regarding submissions and approvals to support continued product supply

· Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions

· Resolve project issues through collaboration with the team and escalation to the DDDC (Devices and Drug Device Combination) leadership team as appropriate

· Participation in early and late development programs, as well as departmental and cross-functional efforts to improve combination product content or processes may also be required, as needed

Education Minimum Requirement:

· B.S. in a science, engineering, or a related field (advanced degree preferred). Preferred fields of study include Biology, Biochemistry or Engineering

Required Experience and Skills:

· A minimum ten (10) years of industry / regulatory experience (5 years with an advanced degree) in pharmaceutical, medical device or combination product research, development and/or manufacturing

· Experience in CMC regulatory (IND, CTA, BLA, MAA)

· Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.

· Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data.

· Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner.

· Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.

· Demonstrated effective leadership, project management, communication, interpersonal and negotiating skills.

· Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders

· Strong knowledge and understanding of design controls process

Leadership Skills:

· Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders

· Demonstrated flexibility in responding to changing priorities or dealing with unexpected events

· Demonstrated effective leadership, communication, interpersonal and negotiating skills in particular with cross functional partners and health authorities

Preferred Experience and Skills:

· Subject matter expertise in combination product regulatory development and manufacturing

· Experience with IDE/IND/510(k) clearances/CE mark authorizations/NDA/BLA/post-approval experience in medical devices or combination products

· Strong knowledge and understanding of design controls process

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We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.

Who we are …

We are known as Merck & Co., Inc., Rahway, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliv

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Job Posting: JC224594245

Posted On: Sep 24, 2022

Updated On: Oct 05, 2022