Principal Scientist (Director) - Regulatory Affairs-CMC

Job Description

Director, Combination Product Regulatory CMC - (R5)

This Principal Scientist position is equivalent to a Director position. Under direction from the Combination Product Regulatory CMC Team Leader, the Principal Scientist is responsible for executing in the Regulatory CMC space. Leveraging demonstrated capability in Regulatory CMC, this candidate will contribute to and implement Device and Drug-Device Combination regulatory strategies for our organization in accordance with domestic and international regulations and guidance. The Principal Scientist is responsible for the preparation and submission of combination product sections of regulatory submissions, correspondences, etc. for commercial and development products. Focus of support will be most often with sterile injectables; pre-filled syringes and/or autoinjectors. The successful candidate will lead the development and the implementation of regulatory strategies for their assigned projects and provide mentoring and coaching to the larger team.

The Principal Scientist responsibilities and skills include but are not limited to:

• Serve as a Combination Product Regulatory Lead and provide leadership within Regulatory and cross-functional teams for assigned products and projects.

• Lead the development, communication, and review of Regulatory Strategies and execute on various deliverables for submission and approval of complex investigational new drugs (IND), biologic license applications (BLA), original NDA/MAA, agency background packages, post-approval submissions/variations, and responses to health authority questions according to defined timelines.

• Collaborate with partner groups in the authoring and reviewing process to ensure compliance, scientific excellence, accuracy and completeness of submissions in the area of combination products.

• Resolve complex project issues through collaboration with the team and cross functional partners and provide recommendations to Regulatory leadership as appropriate.

• Maintain in depth knowledge of global device and drug/biologic-device combination product guidelines and policy regarding IND/CTA, original NDA/MAA, agency background packages, post-approval submissions/variations, 510(K)s, CE markings.

• Collaborate with Device Development, Device Quality, and other Drug stakeholders to communicate and align on new combination product regulations and requirements to ensure internal procedures and processes are compliant for the pipeline. Participate in activities and teams related to device and combination products with these stakeholders.

• Participation and leadership in departmental and cross-functional efforts to improve combination product content or processes may also be required. Provide evaluations of regulatory state of affairs of any devices and combination products for due diligence of potential suppliers, partners, or acquisitions.

• Manage or mentor junior team members, as warranted.

Education Minimum Requirement:

• B.S. in a science, engineering, or a related field (advanced degree preferred). Fields of study include Biology, Microbiology,or Biochemistry, Chemical, Mechanical and Electrical Engineering.

Required Experience and Skills:

• Demonstrated experience in a CMC regulatory role, with a successful track record executing on regulatory CMC deliverables (IND, CTA, BLA, MAA) with a drug-device product.

• A minimum ten (10) years of industry / CMC regulatory experience (5 years with an advanced degree) in pharmaceutical or combination product research, development and/or manufacturing.

• Demonstrated sound understanding of related fields (e.g., manufacturing, process development, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.

• Proven experience in critically reviewing detailed scientific information and assessing whether technical arguments are presented clearly, and conclusions are adequately supported by data.

• Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner.

• Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.

• Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.

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 in particular with cross functional partners and health authorities.

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 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:

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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.

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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

$187,000.00 - $294,400.00

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 .

You 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:

No relocation

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Remote

Shift:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Required Skills:

Biochemistry, Biochemistry, Combination Products, Compliance Remediation, Cross-Cultural Awareness, Device Development, Document Control Systems, Employee Training Programs, High Performance Team Building, Immunochemistry, Innovation, Leadership, Management Process, Mentorship, Mergers and Acquisitions (M&A), Microbiological Analysis, Microbiology, Molecular Microbiology, Negotiation, Organizational Capability, People Leadership, Policy Implementation, Project Management, Project Tasks, Regulatory Affairs Compliance {+ 4 more}

Preferred Skills:

Job Posting End Date:

07/11/2025

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