Senior Specialist, Regulatory Affairs

Job Description

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.

Key Functions

• Work closely with various stakeholders to drive the identification, planning, resourcing, execution, and management of regulatory affairs activities that deliver high quality and timely regulatory and safety submissions.

• Independently manage regulatory and safety submission projects at any level of complexity across all submission types.

• Build and drive regulatory cross-functional teams focused on the identification, planning, and execution of regulatory and safety submissions with an end-to-end mindset.

• Facilitate meetings effectively and clearly communicate decisions and action items to team members and relevant parties outside of the team.

• Identify, assess and actively resolve or escalate, where necessary, any risks or issues that could impact the successful completion of submissions.

• Actively manage timelines including a clear understanding of dependencies and critical path.

• Ensure project data, including information used to maintain compliance and aid with submissions planning, are accurately reported in databases and understood by stakeholders.

• Work closely with functional areas to assess collection of submissions to manage sequencing and possible execution issues for assigned products, as needed.

• Proactively drive project teams, establish appropriate level of urgency, and maintain focus on deliverables.

• Monitor team dynamics regularly to ensure optimal team performance.

• Take action to correct problems within a team stemming from miscommunication, differences of opinion, misaligned objectives, and inexperience.

• Actively lead and/or participate in continuous improvement activities including business processes, tools, systems, metrics and analytics.

• Take advantage of opportunities to increase knowledge of the discipline of project management and understanding of drug/vaccine/biologics development and regulatory practices in the pharmaceutical industry and to improve leadership skills.

Education

• Must have a Bachelor’s degree in Regulatory Affairs or Pharmaceutical Science.

Experience | Skills | Knowledge

Required

• At least two years working experience within a healthcare/consumer care industry project management, regulatory affairs, and/or pharmacovigilance/risk management function.

• Experience with managing successful delivery of regulatory submissions also required.

• Must be technically skilled in project management methodologies (e.g. PMP).

• Ability to lead by influence and work effectively in matrix organizational structures; effective at energizing others, establishing clear goals, delegating responsibility, mentoring and coaching within a team setting; well developed and effective team facilitation and leadership skills; ability to establish cooperative team environments; and ability to understand details, but keep overall "big picture" view of projects and strategies, also required.

• Telecommuting permitted.

• 40 hours per week: M-F – 9am-5pm.

• Must have proof of legal authority to work in the United States

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.

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.

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 Know Your Rights

EEOC GINA 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.

Learn more about your rights, including under California, Colorado and other US State Acts

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:R235209