Specialist, Regulatory Liaison, Regulatory Affairs International

Job Description

The Specialist, Regulatory Liaison is the Subject Matter Expert (SME) on the FDA requirements for a US Certificate of a Pharmaceutical Product (CPP) that is provided by the FDA.

The CPP was originally recommended by The World Health Organization to help undersized health authorities without proper quality assurance facilities in importing countries or secondary markets to assess the quality of pharmaceutical products as prerequisite of registration or importation.

The main role of the Specialist is to procure US CPPs from the FDA using an online application tool by inputting the required information for each specific product’s CPP. Several hundred US CPPs are procured per year, which importing countries rely on to support various submission types such as renewals, GMP status, global registrations, tender bids, site name changes and CMC variations.

The Specialist reports to a Director.

Our Regulatory Affairs team bring new medical advancements to the world by facilitating communications and procedures that allow swift, organized compliance partnering with external regulatory agencies. We are on the leading-edge of healthcare breakthroughs that help provide new, reliable, and compliant medical products, practices and solutions to the world.

Specific responsibilities (with coaching and managerial oversight) include:

• Procure several hundred US CPPs per year from the FDA, adhering to strict guidelines.

• Lead successful efforts to identify, resolve root cause of FDA rejections, which involve modifying all "return for action" CPP notifications from the FDA within a three-day deadline.

• Collaborate with Regulatory Affairs Liaisons at HQ and Subsidiary Registration Managers on regulatory submission strategies when CPPs are on the critical path for new product filings.

• Head communication with the FDA Export Certificate Program, maintaining relationships with key contacts in order to continue a constant flow of accurate and on-time CPPs.

• Work with functional areas such as CMC, Labeling, RAI-HQ and outsource partners to resolve CPP process conflicts and improve communication with the FDA to procure CPPs on time for regulatory submissions.

• Help identify business process improvement opportunities for CPPs procurement.

• Research and download current US packaging labels and package inserts from appropriate artwork database to accompany the CPP applications.

• Present at various forums globally on the US CPP Requirements and Ordering Process to provide a high-level understanding for all US CPP Requesters, including submission managers, vendors, regional liaisons, CMC, etc., to insure right first time CPPs and timely provision to HAs.

• Provide legalization activities for CPPs and Ancillary Documents.

• Procurement and provision of Ancillary Documents.

Required Qualifications/Experience:

Education:

• Bachelor’s degree is required

Requirements:

• Previous experience with provision of US CPPs (US Certificate of Pharmaceutical Product)

• Knowledge of US Legalization and apostille requirements for global documents

• Minimum 12 months experience in pharmaceutical industry

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

• Detail oriented

• Ability to communicate effectively, both verbally and written, with others across all levels of the organization

• Ability to work in a matrix organization

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., Rahway, 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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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US and Puerto Rico Residents Only:

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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.

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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):

Requisition ID:R242686