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Merck Director, Regulatory Affairs Oncology in Rahway, New Jersey

Job Description

Our Regulatory Affairs team brings 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.

The Director, Regulatory Affairs Oncology, is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in the Oncology, Immunology and Devices therapeutic area. The individual functions with a high degree of independence and provides regulatory oversight for assigned products, in order to optimize label and obtain shortest time to approval by regulatory agencies. Independently manages projects, functioning as the single, accountable, global point of contact on those projects. Independently interacts with the Worldwide Regulatory Agencies and/or subsidiaries with regard to global regulatory strategy/registration requirements for one or more of our Company's investigational and marketed drugs/Biologics. Programs may be complex with more than one indication, formulation or have an external business partner. Coordinates the preparation, submission and follow-up contact with regulatory agencies and/or subsidiaries for all applications and submissions. Responsible for regulatory review and final approval for all submissions and associated documentation. Provides expertise as worldwide regulatory representative to Product Development Teams and regulatory single point-of-contact for products within Global Regulatory Affairs and Clinical Safety (GRACS) and external to GRACS.

Primary Responsibilities:

  • Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval by regulatory agencies for multiple indications simultaneously.

  • Provide expert advice to Product Development Teams and subsidiaries on regulatory issues as they arise with the developmental compounds or marketed products throughout the entire life cycle of the drug.

  • Provide leadership to the staff by coordination of cross-functional regulatory support for development programs and marketed products.

  • Review and provide final approval of local registration study protocols when needed to obtain marketing authorization in secondary markets.

  • Represents our Company with external organizations through direct communication with the FDA, including telephone calls and e-mail; chair meetings between company and FDA; prepare our Company's teams for meetings with FDA at any phase of drug development.

  • Lead cross-functional efforts to prepare for advisory committees and may speak at the advisory committee.

  • Coordinate interactions with foreign agencies through Regulatory Affairs Europe (RAE) and the subsidiary registration departments to support their interactions and provide strategic direction across multiple regions simultaneously.

  • Review and provide final approval Worldwide Marketing Applications, Clinical Study Reports, protocols, Investigator Brochures before release from our Company to external agencies and investigators.

  • Represent Global Regulatory Affairs (GRA) within our Company's internal committees to provide regulatory advice and approval according to the committee charters (therapeutic area Document Review Committees (DRC), Product Development Team (PDT), Early Development Team (EDT), and LEAD.

  • Conducts initial Investigational New Drug (IND)/Clinical Study Authorization (CSA) content review and approval to facilitate initial approval by agencies for conduct of clinical trials.

  • Participate in regulatory due diligence activities for licensing candidate review.

Education Minimum Requirements:

  • B.S. Degree in biological science, chemistry or related discipline, with minimum of 10 years drug development or clinical experience or regulatory affairs.

  • M.S. with minimum of 10 years drug development or clinical experience or regulatory affairs.

  • M.D. with minimum of 5 years regulatory experience.

  • PhD with minimum of 7 years relevant regulatory experience.

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 …

Merck & Co., Inc., Kenilworth, New Jersey, USA is known as “Merck” in the United States, Canada & Puerto Rico. We are known as “MSD” in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse 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 diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth.

INVENT.

IMPACT.

INSPIRE.

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.

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at [email protected]

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

EEOC Poster at https://www.dol.gov/sites/dolgov/files/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEOC GINA Supplement​ at https://www.eeoc.gov/sites/default/files/migratedfiles/employers/eeocgina_supplement.pdf

OFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

OFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdf

We are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully

Merck & Co., Inc., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, 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:

Domestic

VISA Sponsorship:

No

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Number of Openings:

1

Requisition ID: R58276

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