Associate Principal Scientist (Assoc. Director), Regulatory Affairs - CMC

Merck

Job Description

GRACS (Global Regulatory Affairs & Clinical Safety) CMC - Associate Principal Scientist, CMC - Pharm Pre-approval (Respiratory/Inhalation Products)

This Associate Principal Scientist in Pre-approval Pharmaceutical CMC will be responsible for developing and implementing CMC regulatory strategies for our Company's pharmaceutical pipeline products in accordance with global regulations and guidance's, with a focus on small molecule respiratory/inhalation product development. Position will support respiratory/inhalation and some conventional small molecule programs and isresponsible for the preparation and submission of CMC dossiers. Primary responsibilities include, but are not limited to:

Regulatory CMC responsibilities:

• Serve as a CMC Product Lead for assigned products and be accountable for the delivery of all regulatory milestones through product & device development requirements and strategies including assessment of the probability of regulatory success together with risk mitigation measures.

• Lead development and execution of global product and project regulatory strategy(ices) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.

• Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned projects.

• Provide regulatory leadership as needed in product in-license/due diligence review and product transition to the Post-Approval Pharm CMC team.

• 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.

• Prepare and communicate CMC Risk Assessments, contingency plans, lessons learned, and escalate potential regulatory issues to GRACS CMC management, as needed.

• Interprets and communicates regulatory expectations to internal and external stakeholders (including partners, CRO/CMOs) to execute program objectives in compliance with applicable regulations.

• Partner with our quality colleagues to prepare for and support pre-approval and regulatory inspections, ensuring launch readiness and regulatory success.

• 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's pharmaceutical products worldwide.

• Conduct all activities with an unwavering focus on compliance.

Education:

• 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

Required:

• At least five (5) years of relevant experience, including biological/pharmaceutical research; manufacturing, testing, or regulatory CMC; or related fields.

• The candidate must be proficient in English; additional language skills are a plus.

Preferred:

• The ideal candidate will have experience in Regulatory CMC or in preparation of regulatory filings with technical leadership skills, as well as demonstrated understanding of related pharmaceutical operations (e.g., manufacturing, process development, analytical, quality assurance).

• 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 be familiar with the latest global regulatory guidance's and pharmacopeial methods with a demonstrated ability to apply them to build regulatory strategies related to Inhalation products.

• The candidate must demonstrate the ability to develop innovative and imaginative approaches to problem solving and the ability to flexibly respond to changing priorities or unexpected events.

• They must have 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.

• They 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:

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 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

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.

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

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

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.

You can apply for this role through https://jobs.merck.com/us/en (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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*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.

Requisition ID:R383239