Prin. Scientist, (Director) Regulatory Affairs-CMC

Merck & Co.

Upper Gwynedd Township (Montgomery County)

Hybrid

USD 191,000 - 300,000

Full time

12 days ago

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Benefits offered by this job

Annual bonus

Long-term incentive

Medical, dental, vision coverage

401(k)

Job summary

Merck & Co. is seeking a Regulatory CMC Principal Scientist to lead global regulatory strategies for small molecules and peptides. You will drive CMC milestones, prepare submissions, and coordinate with authorities to ensure timely approval and market supply of products worldwide.

You will oversee IND/CTAs and agency background packages, mentor staff, and ensure compliance with global regulations while collaborating across diverse functional teams in a dynamic, international environment.

Qualifications

B.S. in a biological science, engineering, or related field; advanced degree preferred.
5–10 years of pharmaceutical development experience in related fields.
At least 7 years' experience in Regulatory CMC roles, leading NDA/MAA CTD content.
Proficiency in English; additional languages a plus.

Responsibilities

Serve as a CMC Product Lead for new small molecule and peptide products; oversee regulatory milestones.
Lead Regulatory CMC discussions with regulatory agencies to facilitate review and approvals.
Provide regulatory leadership and strategy to a matrixed team in developing global CMC strategies and executing submissions.
Oversee IND/CTA, Agency Background Packages, and Worldwide Marketing Applications.

Skills

Regulatory CMC leadership

Global regulatory strategy

IND/CTA/CTD knowledge

Strong communication

Education

B.S. in biological science or related field

Advanced degree preferred

Job description

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 company's 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:

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 elevate 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 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.-
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 69,000 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 world's 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 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 another's thinking and approach problems collectively.

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.

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 characteristics.--As 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

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

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 .

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

Employee Status

Regular

Relocation

Domestic

VISA Sponsorship

Travel Requirements

No Travel Required

Flexible Work Arrangements

Hybrid

Shift

1st - Day

Valid Driving License