Senior Specialist, Regulatory Submissions Manager

Job DescriptionRegulatory Planning & Execution works closely with various stakeholders to drive the identification, planning, resourcing, execution, and management of activities to deliver high quality and timely regulatory and safety submissions.Responsibilities include independent management of all submission projects, at any level of complexity, across all submission types throughout the product lifecycle. The incumbent is expected to be skilled in project management with a demonstrated track record of leadership in a cross-functional setting. Additionally, the incumbent may be involved in leading or supporting internal or external process improvement or strategic initiatives.In collaboration with the submission planning team, actively participates in planning forum meetings to assist with submission activities which may include (but not limited to): RTQs (response to questions); submission plans; issue identification; etc.

Helps identify business process improvement opportunities, documentation updates and/or training to prevent practices which could lead to quality deviations or non-compliance events.

Liaises with all pillars of the RPE organization to ensure timely and quality submissions, as the business requires.

Responsible for the creation of submission plans in the planning tool to ensure correct components and timelines are captured

Required Experience & Skills:Education Minimum Requirement Bachelor’s Degree

0-3 years of working experience within a healthcare/consumer care industry project management, regulatory affairs, and/or pharmacovigilance/risk management function.

Ability to communicate effectively, both verbally and written, with others across cultures, organizational level and disciplines within a matrix organizational structure

Ability to understand tactical details, but keep overall “big picture” view of projects and strategies

Self-starter, fast learner with analytic and problem-solving capabilities and the ability to innovate and perform in a fast-paced team environment

Proficient with computer systems (MS Office necessary; Advanced Excel and Word skills preferred)

Highly organized individual with keen attention to detail

Desired Experience, Education & Skills:

Demonstrated leadership, initiative and ownership of deliverables

Effective at energizing others, establishing clear goals, delegating responsibility, mentoring and coaching

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.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 APPLICANTSIn 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 staffingaadar@msd.comFor 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.pdfEEOC GINA Supplement​ at https://www.eeoc.gov/sites/default/files/migratedfiles/employers/eeocginasupplement.pdfOFCCP EEO Supplement at https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdfOFCCP Pay Transparency Rule at https://www.dol.gov/ofccp/pdf/pay-transp%20EnglishformattedESQA508c.pdfWe are an equal opportunity employer, Minority/Female/Disability/Veteran – proudly embracing diversity in all of its manifestations.Search Firm Representatives Please Read CarefullyMerck & 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:RegularRelocation:No relocationVISA Sponsorship:NoTravel Requirements:10%Flexible Work Arrangements:Not SpecifiedShift:Valid Driving License:Hazardous Material(s):Number of Openings:1Requisition ID: R60271