Director/Principle Scientist Regulatory Affairs (CMC) Chemistry, Manufacturing and Control - Biologics ( MERCUSR60693ENUS)
Our Regulatory Affairs team brings 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.
Under general supervision of an Executive Director, the Principal Scientist/Director is responsible for developing and implementing Chemistry, Manufacturing, and Control (CMC) regulatory strategies for our organization's biologics product franchises in accordance with domestic and international regulations and guidance. The Principal Scientist is responsible for the leading the preparation and submission of CMC sections for commercial or new biologics products. The Principal Scientist will lead the development and the implementation of internal regulatory strategies and provides mentoring and coaching to Senior Scientist and Associate Principal scientist in support of their assigned projects. The Principal Scientist/ Director responsibilities include, but are not limited to:
- Serve as a Regulatory CMC Project Lead and provide CMC Regulatory leadership within Regulatory and on cross-functional teams for the assigned biological products in development or commercial products.
- In depth knowledge and application of global CMC guidelines regarding investigational new drug (IND)/biologics license applications (BLAs) or post approval changes.
- The CMC Project Lead is accountable for the delivery of all regulatory milestones for higher complexity products including assessment of the probability of regulatory success together with risk mitigation measures.
- Lead the development, communication, and review of the CMC Regulatory Strategy Document for projects of increasing complexity.
- Lead development and execution of detailed, global regulatory submissions of INDs, BLAs or post approval change documentation according to defined timelines.
- Manage execution of CMC documentation including IND/clinical trial application (CTA), original BLA/marketing authorization application (MAA), or Post Approval Life Cycle, including agency background packages and response to health authority questions per established business processes and systems.
- Collaborate with partner groups in critical review of submissions to ensure compliance, scientific excellence, accuracy and completeness of submissions.
- Resolve complex project issues through collaboration with the team and cross functional partners and provide recommendations to Regulatory CMC leadership team as appropriate.
- Provide regulatory leadership as needed in product in-license/due diligence review, product divestment and product withdrawal.
- Support new technology development within our Company.
- Demonstrate an understanding of regulatory affairs and applies this understanding to the benefit of the company to ensure the approval or continued market supply of our Company's Biologics products worldwide.
- Conduct all activities with an unwavering focus on compliance.
- May need to manage or mentor junior team members.
- 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. Strong listening skills.
- Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
- 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.
Education Minimum Requirements:
- B.S. in a biological science, engineering, or a related field (advanced degree preferred). Fields of study include Biology, Microbiology, Virology, Molecular Biology, Chemical Engineering, Chemistry or Biochemistry.
Required Experience and Skills:
- At least fifteen (15) years of relevant experience (10 years with an advanced degree), including biologics or vaccine Regulatory CMC, or development; manufacturing, testing, or licensure of biological products; or closely related fields.
- The candidate must be proficient in English; additional language skills are a plus.
- The candidate may be required to travel on a periodic basis.
Preferred Experience and Skills:
- Experience in Biologics preferred.
We are a research driven bio-pharmaceutical 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.
Who we are …
We are known as Merck & Co., Inc., Kenilworth, 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 deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.
What we look for …
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 diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.
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