Prin. Scientist, (Director) Regulatory Affairs-CMC

Job Description

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 companys 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:

Responsibilities:

• 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 generateinnovative 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.

Who we are

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 69000 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 worlds biggest investors in Research & Development.

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 perspective to our organization. Together we will continue Inventing Impacting Lives while Inspiring Your Career Growth.

INVENT

IMPACT

INSPIRE

We are proud to be a company that embraces the value of bringing talented and committed people fastest way to breakthrough innovation is when ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers 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:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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.

As an Equal Employment Opportunity Employer we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race color age religion sex sexual orientation gender identity national origin protected veteran status disability status or other applicable legally protected a federal contractor we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws visit:

EEOC Know Your Rights

EEOC GINA Supplement

We are proud to be a company that embraces the value of bringing together talented and committed people with diverse experiences perspectives skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas broad experiences backgrounds and skills come together in an inclusive environment. We encourage our colleagues to respectfully challenge one anothers thinking and approach problems collectively.

Learn more about your rights including under California Colorado and other US State Acts

The salary range for this role is

$190800.00 - $300300.00

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 employees 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 can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

San Francisco Residents Only:We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only:We will consider for employment all qualified applicants including those with criminal histories in a manner consistent with the requirements of applicable state and local laws including the City of Los Angeles Fair Chance Initiative for Hiring Ordinance

Search Firm Representatives Please Read Carefully
Merck & Co. Inc. Rahway NJ USA also known as Merck Sharp & Dohme LLC Rahway 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:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

No Travel Required

Flexible Work Arrangements:

Hybrid

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Job Posting End Date:

09/25/2026

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.