Executive Director, Global Regulatory Affairs - CMC

Job Description

Subject to applicable law, all prospective hires will be required to demonstrate that they have been fully vaccinated for COVID-19 or intend to be vaccinated for COVID-19 by November 1, 2021, or qualify for a medical or religious accommodation to this vaccination requirement. Hired candidates who are not vaccinated by November 1, 2021, and who have not been approved for a legally-required medical or religious accommodation will be subject to disciplinary action up to and including termination of employment, in accordance with applicable law.

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 Executive Director, Global Regulatory CMC, will identify external innovation that can accelerate the goals of the our Research & Development, Manufacturing and CMC Regulatory Divisions. 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 our CMC Regulatory, Research & Development and Manufacturing divisions 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, along with team members, 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 our Company's positions through appropriate formal and informal discussions

Working collaboratively with members of the CMC policy team, the modalities and others as relevant the individual in this position will prioritize advocacy 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 Regulatory CMC, Manufacturing, Global Human Health 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 in one of the modalities (Biologics, Vaccines or small molecules) and is expected to provide leadership and direction to the Regulatory CMC policy team. The individual and his/her team members will provide direction and mentorship to team leaders and members that are responsible for developing and executing regulatory strategies and e 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 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 department and will also serve as the liaison to the (GRP) Global Regulatory Policy Team by sitting on the GRP leadership team as needed. He/she will support the department in all relevant areas of expertise and 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. The individual in this role will be expected to serve as the single point of contact for all CMC policy related topics and should have the requisite leadership skills and influencing skills to leverage various parts of Regulatory CMC (including iCMC), Global Regulatory Affairs & Clinical Safety, Manufacturing and Research & Development divisions to establish the framework for centralizing and prioritizing policy/influencing topics.

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 Merck 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.
• An advanced degree (Ph.D.) in Sciences or Engineering is preferred.

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.

Preferred:

• 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.
• A candidate with strong experience with expertise in one of the modalities (small molecules/biologics/vaccines) is highly preferred.
• 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.

GRACSJOBS

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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Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.

For more information about personal rights under Equal Employment Opportunity, visit:

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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.

Search Firm Representatives Please Read Carefully
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.

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Requisition ID:R93843