Prin. Scientist, (Director) Regulatory Affairs-CMC Full-time

Regulatory Cmc Principal Scientist

The Regulatory CMC Principal Scientist is responsible for developing and implementing CMC regulatory strategies for pharmaceutical products in accordance with global regulations, guidance, and our company's procedures. He/she will lead the preparation and submission of CMC dossiers to support global market applications.

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.

Primary responsibilities include, but are not limited to:

• Serve as a CMC Product Lead for new small molecule and peptide pharmaceutical products and be accountable for the delivery of all regulatory milestones throughout product development including assessment of the probability of regulatory success together with risk mitigation measures.
• Lead the Regulatory CMC discussions and interactions with regulatory agencies to facilitate review and approval of new product submissions.
• Provide regulatory leadership, oversight, and strategy to a matrixed team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions related to small molecule and peptide development products. This includes preparation of applicable IND/CTAs, Agency Background Packages, and Worldwide Marketing Applications (including Most of World applications).
• Provide regulatory leadership as needed in product in-license/due diligence review
• Manage execution of CMC documentation including IND/CTA, original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems.
• Identify, communicate and escalate potential regulatory issues to GRACS CMC management, as needed.
• Continuously evaluate and develop talent within the team and prepare a succession plan.
• Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and launch market supply of our company pharmaceutical products worldwide.
• Conduct all activities with an unwavering focus on compliance.

Technical Skills:

• Proven experience in regulatory CMC with strong technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).
• Demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.
• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly and conclusions are adequately supported by data is required.
• In-depth of experience in defining global CMC strategy and must have collaboration and decision-making capabilities to be successful in this role.
• Subject Matter Expertise in a pharmaceutical-related discipline.
• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.

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.
• Ability to lead a team of direct or matrixed colleagues to deliver on business commitments and project timelines.

Qualifications

• B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, or Biochemistry
• 5-10 years of pharmaceutical development experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields.
• At least 7 years' experience in Regulatory CMC roles, leading the preparation of NDA/MAA CTD content.
• The candidate must be proficient in English; additional language skills are a plus.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” and that great medicines can make a significant impact to our world. And 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.

We are a global biopharmaceutical leader with a portfolio of prescription medicines, oncology, vaccines and animal health products.

We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.

In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and perspective to our organization. Together we will continue Inventing, Impacting Lives while Inspiring Your Career Growth.

We are proud to be a company that embraces the value of bringing talented and committed people together. The fastest way to breakthrough innovation is when ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively for the common good. We are an equal opportunity employer, committed to fostering an inclusive workplace.

Required Skills: Adaptability, Audits Compliance, Biotechnology, Change Management, Confidentiality, Cross-Cultural Awareness, Decision Making, Drug Development, Employee Training Programs, Legal Compliance, Life Cycle Support, Pharmaceutical Products, Regulatory Affairs Management, Regulatory CMC, Regulatory Communications, Regulatory Compliance, Regulatory Experience, Regulatory Management, Regulatory Processes, Regulatory Research, Regulatory Strategies, Regulatory Submissions, Technical Writing, Timeline Management

Preferred Skills:

The salary range for this role is $190,800.00 – $300,300.00

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.