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Director, Regulatory Affairs Liaison

Company: Merck & Co., Inc.
Location: Rahway
Posted on: June 12, 2021

Job Description:

Job Description

The Global Regulatory Liaison is responsible for development and implementation of worldwide regulatory strategy for their assigned projects in the Oncology, Immunology and Devices therapeutic area. The candidate will be a self-starter and provide 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 activities include, but are not limited to:

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 direction to the staff by leading the Global Regulatory Team which coordinates 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.

  • 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 of Worldwide Marketing Applications, Clinical Study Reports, protocols, and Investigator Brochures before release from our Company to external stakeholders.

  • Represent 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 labeling teams (LEAD).

  • Conducts initial IND/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.

  • PhD with minimum of 7 years relevant experience.

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

Required Experience and Skills:

  • Ability to achieve optimal results with limited day-to-day direction.

  • Ability to think strategically and continuously learn and apply new knowledge.

  • Ability to lead, influence, and negotiate.

  • Led or directly supported meetings with FDA, EMA, or other Health Authorities.

  • Led or directly supported regulatory filings.

  • Proactive, clear and effective verbal and written communicator.

Preferred Experience and Skills:

  • Oncology experience.

  • Immunology and biologics experience.

  • Substantial experience in regulatory affairs in at least one major country/region (e.g., U.S.A., European Union, Japan, China).

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

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.

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

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., 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:

Yes

Travel Requirements:

10%

Flexible Work Arrangements:

Flex Time

Shift:

1st - Day

Valid Driving License:

No

Hazardous Material(s):

N/A

Number of Openings:

1

Keywords: Merck & Co., Inc., New York , Director, Regulatory Affairs Liaison, Other , Rahway, New York

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