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Associate Director, Regulatory Affairs International (HQ)

Merck Cherokee

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Rockville, MD
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Job Description

As posted by the hiring company

Job Overview:

Job Description

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

In April 2020, our Company announced plans to consolidate our New Jersey campuses into a single New Jersey headquarters location in Rahway, NJ by 2023. Therefore, this role will be temporarily based in a and exact timing of the departmental move to Rahway, NJ will be communicated at a future date.

The Regulatory Affairs International Headquarters (RAI-HQ) R4, Associate Principle Scientist position in the Diagnostics and Devices group is a broad role encompassing all aspects of regulatory strategy including, medical device regulation, diagnostic regulation, Chemistry, Manufacturing and Controls (CMC), clinical efficacy, safety and risk management, and labeling. He/She has direct responsibility for a portfolio of products that generally ranges across all phases of development and includes mature products, medical devices, combination products and diagnostics. The Associate Principle Scientist reports to a Director in RAI-HQ.

The Associate Principle Scientist will have responsibility for an assigned portfolio of products. The individual will have responsibility for leading and strategically driving results on assigned products and projects through alignment and prioritization with Department management and across stakeholders.

This highly enthusiastic, self-motivated individual functions with a high degree of independence and imparts their knowledge to the department as a whole. They have demonstrated their ability to think laterally as well as vertically by looking at how issues potentially can have an impact on other functional areas. Device, diagnostic, combination product, and drug development expertise is leveraged internally to provide advice to RAI HQ Liaisons and externally via committee or cross-functional or cross-divisional team representation and consultation.

Specific responsibilities include:

  • Independently create and drive implementation of a Rest of World (ROW) regulatory strategy for assigned new products to optimize time to approval in collaboration and alignment with the product team.

  • Independently create and drive execution of regulatory strategy to support lifecycle management of In-line (i.e. mature) products.

  • Support for Clinical Trial Applications (CTA’s) in Phase I-III, Product, Registration and Launch (PR&L) filings, and post filing activities.

  • Critically review and provide scientific and regulatory input on background packages for Agency consultation to ensure clarity and comprehensive presentation of issues.

  • Regulatory review of labeling and responsibility for the strategy and release of supplemental safety and efficacy supplements to update the label.

  • Lead, collaborate and communicate with Country Regulatory Leads, Regional Leads, Regional Liaisons, other functional areas within Global Regulatory Affairs and Clinical Safety, and across Divisions to ensure alignment around a common set of priorities and objectives for ROW filings and lifecycle management activities.

  • Lead business process space forums and other organizational initiatives and may represent RAI HQ on cross-functional/cross-divisional teams.

  • Act as the Global Regulatory Team (GRT) Lead for assigned products.

  • Will have some agency interactions such as facilitating responses to agency queries, Pre-Submission Meetings (PSMs), FDA communications, etc.

Required Qualifications/Experience:

  • Previous industry experience is required, specifically in medical devices and/or diagnostics devices.

Education:

  • Degree in Pharmacy, Biological Science, Chemistry, Nursing or related discipline.

Requirements:

  • Bachelor’s degree, preferably in Pharmacy, Biological Science, Chemistry, Nursing or related discipline required with at least 6 years of relevant experience in the diagnostic, device, or pharmaceutical industry. Alternatively a Master’s or other advanced degree with at least 4 years of relevant experience in pharmaceutical industry.

  • Must have excellent communication skills (both oral and written) and strong leadership presence.

  • Good organizational skills with a proven ability to simultaneously balance diverse activities for multiple projects.

  • Flexibility and negotiating skills are required.

  • Demonstrated Leadership skills.

  • Strong scientific and analytical skills.

  • Proactive and creative problem solver that generates options, makes effective and timely decisions and resolves conflicts.

  • Prior regulatory experience is required.

We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. 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 known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world's most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world.

What we look for …

Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us—and start making your impact today.

NOTICE FOR INTERNAL APPLICANTS

In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions.

If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.

GRACSJOBS

New hires in office-based roles in the US & Puerto Rico will be required, subject to applicable law, to demonstrate that they have been fully vaccinated for COVID-19 or qualify for a medical or religious exemption to this vaccination requirement that can be accommodated without an undue burden to the operation. However, subject to applicable law, employees working in roles that the Company determines require routine collaboration with external stakeholders, such as employees in health services, customer facing commercial, or research based roles, will be required to be fully vaccinated as a condition of employment.

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.

For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement​

OFCCP EEO Supplement

Pay Transparency Nondiscrimination

We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

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:

Not Specified

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

Number of Openings:

1