Principal Scientist (Director), Regulatory Affairs-CMC Full-time

Principal Scientist, CMC, – Pharm Pre-approval (Inhalation/Respiratory Franchise)

Reporting to the Ex-Director/ Sr. Director in Pre-approval Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our Company's pharmaceutical pipeline products in accordance with global regulations and guidance's, with focus on small molecule respiratory/inhalation product development. Position will primarily lead oversight of multiple programs in Respiratory franchise and some conventional small molecule programs.

Primary responsibilities include, but are not limited to the following:

• Provide regulatory leadership, oversight, and strategy to a team of Regulatory CMC Professionals in developing global Regulatory CMC strategy and executing submissions related to small molecule, development products. This includes preparation of applicable IND/CTA's, Agency Background Packages, Worldwide Marketing Applications (including Most of World applications), and transfer strategy to post-approval grp. for further submissions occurring within several years post-launch in the major markets.
• This role may also directly support a project in a similar capacity; however, the primary focus of the position is providing direction to the team members that are responsible for developing and overseeing implementation of regulatory strategies, and making decisions that ensure high quality, accuracy, and high likelihood of approval of all regulatory submissions. This includes assessing CMC changes during development, 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.
• Be responsible for proactive and timely communication of regulatory risks, challenges, and opportunities to management to help address them in a systematic and thoughtful manner. Develop, execute & provide oversight of regulatory initiatives & strategies of significant complexity and apply exceptional ingenuity to solve problems and mitigate potential regulatory challenges. Drive the application of regulatory strategies and concepts across multiple disciplines and multiple organizations, including working directly with Senior Leadership in these areas. Embody our Company's Values and Leadership Behaviors in day-to-day activities and serve as an example by practicing them consistently.
• Continuously evaluate and develop talent within the team and prepare a succession plan. Use recognition and rewards to promote team and organizational collaboration. Set a vision for the team and hold employees accountable for the execution of departmental policies and procedures. Manage resources and prioritization within assigned areas. Actively sponsor employees who lead and participate in our Company's initiatives. Develop strong collaborative relationships with stakeholders and partners across the organization. Represent the department's needs and positions in senior leadership forums. Develop and maintain expert knowledge of current global regulatory CMC requirements for IND/CTA submissions, and original registrations. Identify and resolve technical and operational problems associated with regulatory strategy and submissions using rapid, disciplined decision making; collaborate with peers to resolve cross-functional obstacles using excellent critical thinking skills. Candidates should have the ability to adapt to change and work in a fast-paced, demanding environment. Establish, refine, and ensure adherence to internal regulatory SOPs to optimize operational efficiency and compliance. Partners with Quality colleagues strategically prepare for and lead pre-approval and regulatory inspections, ensuring launch readiness and regulatory success. Champion a culture of continuous improvement, driving operational excellence and innovation in regulatory process and cross-functional collaboration.
• Look for innovative and scientifically sound approaches to gain approval of new products. Participate in the development of CMC business processes or organizational initiatives as needed. Lead the Regulatory CMC discussions and interactions with regulatory agencies to facilitate review and approval of submissions. 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. Present and participate at industry meetings.

Position Requirements:

• Education Minimum Requirement: Master's degree in chemistry, Pharmacy, or a related discipline; post-graduate degree preferred.
• Required Experience and Skills: Minimum 15 years pharmaceutical industry experience; 10 years with an advanced degree. Minimum 5 years working in Regulatory CMC, including the development stages of the product life cycle, and a minimum of 3 years managing people.

Preferred Experience and Skills:

• 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, quality assurance) and experience managing a team of Regulatory CMC professionals.
• Regulatory CMC experience with complex drug-device combination products/ inhalation products including nebulizers, dry powder inhalers and metered dose inhalers is required. Preferably the candidates should have a comprehensive knowledge of the latest global regulatory guidance and pharmacopeial methods with a demonstrated ability to apply them to building regulatory strategies related to Inhalation products.
• The candidate should have a good understanding of characterization studies and key analytical methods used for inhalation products.
• 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. Must have a depth of experience in defining global Regulatory CMC strategy, 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 & 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.
• Must have proven experience in critically reviewing detailed scientific information and assessing the technical arguments presented with clear and concise conclusions adequately supported by data. The candidate must be proficient in English; additional language skills are a plus.

Required Skills:

Audits Compliance, CMC Development, Data Integrity, Documentations, Dry Powder Inhalers (DPI), Employee Training Programs, Organizational Optimization, Pharmaceutical Process Development, Pharmacology, Production Optimization, Product Lifecycle, Regulatory CMC, Regulatory Compliance, Regulatory Experience, Technical Writing

Preferred Skills:

Inhalers

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday – Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.

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.