Senior Technical Regulatory Advisor- Vaccines CMC (Chemistry, Manufacturing, and Control) Policy

Job Description

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.

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.

Reporting to the Head of Global Regulatory CMC, Biologics, Devices/Combination Products and CMC Policy, the Senior Technical Regulatory Advisor will identify external innovation that can accelerate the goals of our Research & Development, our Manufacturing Division and CMC Regulatory, with a focus in the vaccines modality. To achieve this, he/she needs to utilize their extended network to ensure our Company is the “go to” place for innovation, which may emanate from a wide array of forums including leading universities. He/she will ensure our Company is represented and called upon to influence key policy, regulatory, healthcare decisions, etc. and is viewed as a leader of best-in-class scientific technology. He/she will work with CMC Key opinion leaders (KOL’s) to ensure that new regulations are appropriately scientifically based and facilitate the successful introduction of new and differentiated pharmaceutical products. He/she is expected to position CMC Regulatory, our Research & Development Division and our Manufacturing Division as an organization that sets global industry standards for excellence in both large and small molecule development. In collaboration with the policy network across CMC, he/she will enable the organization to understand trends and changes as well as expectations of regulators and technology to address topics proactively. He/she will represent our Company in applicable external forums (PHRMA/BIO/EFPIA/IFPMA) and drive our Company's position on key topics. He/she will need to leverage the extensive external network of regulators, industry, and academicians to understand/benchmark current trends/views and enable advancement of Company positions through appropriate formal and informal discussions

Working collaboratively with the vaccines CMC team, the CMC policy team and others as relevant the individual in this position will prioritize biologics topics requiring attention, draft position papers and leverage them to influence stakeholders internally and externally. It is imperative that the/she work collaboratively with other key leaders in our regulatory CMC, Manufacturing Division and Research & Development Divisions, to ensure complete alignment. The individual will be required to engage with key internal stakeholders to ensure they are aligned with new scientific technologies that may be introduced and incorporated. The individual will work close with the functional leadership, develop and implement the short as well as long term strategy by ensuring appropriate buy-in from all key stakeholders.

The individual in this position is expected to serve as a SME and provide direction and mentorship to team leaders and members that are responsible for developing and executing regulatory strategies and enabling personnel to make decisions that ensure the high quality, accuracy, and high likelihood of approval of all regulatory submissions. He/she will also be expected to serve as a naïve reviewer of regulatory strategies/submissions and enable the incorporation of novel approaches in regulatory submissions. This includes defining regulatory requirements, developing CMC regulatory strategies demonstrating sound regulatory insight, ensuring a balanced approach to regulatory risk, understanding the impact to the business, utilizing regulatory intelligence and incorporating knowledge of the changing regulatory environment. This includes applicable sections of clinical and post approval application, Agency Background Packages, Worldwide Marketing Applications, and responses to Agency questions for global markets.

The individual in this role will need to understand regulatory submissions, global challenges and the nuances of our Company's systems and processes. This individual will be a key, senior member of the modality leadership team supporting the department in all relevant areas of expertise. This individual will be responsible to evaluate the various policy related processes and help streamline approaches that increase efficiency and enhance the effectiveness of the evaluation, communication and implementation across our Company's.

He/she will embody the Company Values and Leadership Behaviors in day-to-day activities and serve as an example by practicing them consistently. He/she will continuously evaluate and develop talent within the team and prepare a succession plan. He/she will use recognition and rewards to promote team and organizational collaboration and actively sponsor employees who lead and participate in Company initiatives. He/she will cultivate and foster strong collaborative relationships with stakeholders and partners across the organization, and represent the department’s needs and positions in senior leadership forums.

The individual will be required to develop and maintain an expert knowledge of Industry Association Whitepapers, Health Authority regulations & guidance documents. Utilize expert knowledge and reputation to influence the content of new Industry Association Whitepapers, Health Authority guidance & regulations. He/she will be actively involved in Industry meetings and present at them to help further our Company's position on key topics.

Education:

• Degree in pharmacy, chemistry, engineering, biology or a related discipline.

Required:

• 15-plus years of senior level experience in pharmaceuticals, biotech, or at FDA/EMA leading a part of a global CMC organization. Extensive network that includes regulators, industry colleagues and academicians.
• The ideal candidate will have strong experience in Regulatory CMC with strong technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, and quality assurance)
• The ideal candidate should have built a highly credible and significant external network, may have already garnered a reputation of endorsing external innovation into a CMC organization.
• He/she should have obtained a leadership position through a career that has been gained in roles which include: drug product & analytical development, all phases of product development/and or supply chain for clinical and commercial supplies.
• He/she should have a comprehensive understanding of quality and regulatory compliance, plus a broad understanding of the various regulatory requirements worldwide. Have invested time building key relationships with major regulators.
• The candidate must demonstrate the ability to develop creative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.
• He/she must have a depth of experience, superb collaboration skills, rapid, disciplined decision making and critical thinking capabilities, and work well under pressure to be successful in this role.
• The candidate must have excellent interpersonal, verbal and written communication, presentation, and listening skills with a proven record of working with, and influencing, multi-disciplinary teams and external experts.
• The candidate must have demonstrated experience in building, rewarding and retaining key talent.
• He/she must have proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data.
• The candidate must be proficient in English; additional language skills are a plus.

Preferred:

• A candidate with strong experience with biologics/vaccines expertise is highly preferred.

GRACSERP

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.

INVENT.

IMPACT.

INSPIRE.

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

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Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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.

Employee Status:

Relocation:

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Requisition ID:R92806