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Compliance Navigator

Employer
Regeneron Pharmaceuticals, Inc.
Location
Tarrytown, New York
Start date
Sep 8, 2021

View more

Discipline
Regulatory, Legal/Compliance
Required Education
Bachelors Degree
Position Type
Full time
Hotbed
Pharm Country, Best Places to Work

Job Details

Reporting to the Compliance Strategy Lead, the Risk Navigator is a strategic and dynamic role. This individual will conduct day-to-day risk assessment and management to help support the vision for compliance at Regeneron, by embedding ethical and risk-informed decision-making into the organization. This role is expected to be the key liaison to all business functions on compliance-related business topics. This individual will rotate across key business teams and activities to integrate practical compliance best practices within business processes. In addition, this individual will synthesize learnings from partnerships across business functions to develop innovative and agile methods to better identify compliance risks and enhance monitoring opportunities. This individual will be expected to inspire proactive collaboration throughout Regeneron, enable business ownership of risk, and prioritize for impact. Core expectations for this role include:

  • Agility: prioritizing risk and shifting between changing business areas, initiatives, and objectives;
  • Influencing and advocacy: leveraging substance and relationship-building to effectively navigate an organization and advance Compliance objectives; and
  • Driving solutions that are fit for purpose: developing practical Compliance initiatives by blending knowledge of Compliance standards, practical experience, and knowledge of potential perception/execution risk.

As the Risk Navigator, a typical day might include the following:

  • Integrate into business functions to gain an in-depth understanding of current state processes and provide proactive compliance guidance on the development and execution of proposed strategic and tactical initiatives;
  • Develop, enhance, and implement Compliance policies and procedures that are fit for Regeneron and reflective of applicable laws, regulations, government guidance, industry codes, and Regeneron policies;
  • Strategize business process improvements and change management implementation to support business and compliance leadership in achieving operational gains;
  • Develop and implement strategic and practical risk assessment processes and management interventions that are aligned with prioritized risk areas particular to business operations and relevant monitoring activities;
  • Identify emerging compliance key risk indicators to inform Compliance monitoring teams and analytics with practical insights from business activities;
  • Strategize innovative ways to transform internal education initiatives, through acting as a business partner between Regeneron Compliance training leads and business functions, to bridge current knowledge gaps with targeted training content;
  • Inform business leadership of compliance knowledge gaps and larger organizational trends in a timely manner, while encouraging the open and proactive flow of information between colleagues and lines of business;
  • Act as primary point of contact for business functions to provide regular advice and support to ensure appropriate compliance controls are incorporated in decision-making processes and business projects; and

This role may be for you if you:

              Preferred

  • Have a J.D. from an accredited law school, or other relevant advanced degree, and be able to demonstrate a history of successfully resolving challenging Compliance/legal issues and ability to effectively deliver sound and clear Compliance/legal advice in a business setting.

Required

  • Have the capabilities and ambition to embrace and model the “Regeneron Way” by:
    • Taking on big ideas through entrepreneurial spirt, drive, ownership, and perseverance;
    • Making it happen through flexibility, process & planning, and Compliance;
    • Being great together through teamwork & collaboration, being extraordinary, learning, communication, and care; and
    • Doing what’s right through respect, inclusion, patient focus, safety & quality, and integrity & trust.
  • Have 5+ years of diversified biotech/pharmaceutical industry experience, including a minimum of 3 years of experience in US Compliance roles;
  • Have prior project management experience;
  • Demonstrate a history of successfully resolving challenging compliance issues and have compliance experience outside of traditional commercial practices (e.g., Clinical, Manufacturing);
  • Able to effectively deliver sound and clear compliance advice in a business setting;
  • Have demonstrated knowledge of relevant laws, regulations, and industry practices, including the US Federal Sentencing Guidelines, the Federal Anti-Kickback Statute, the False Claims Act, the Food Drug & Cosmetic Act, the Sunshine Act, the PhRMA Code (and other applicable industry codes), HIPAA, GDPR, etc.;
  • Have a successful track record of developing and managing multiple elements of a compliance program (ideally a program that was principle based and reinforced practical compliance controls that aimed to align Compliance and business objectives;
  • Demonstrate confidence in developing practical compliance solutions across business processes by blending knowledge of compliance standards, practical experience, and knowledge of potential perception/execution risk;
  • Foster a strong internal compliance, ethics, and speak-up culture by creating an environment in which employees see the Compliance function as a strategic partner and enabler;
  • Are able to build consensus and respectfully drive decision-making regardless of issue popularity;
  • Have willingness and desire to be a strategic leader that can drive meaningful impact aligned with Compliance organization and enterprise priorities without being dictated by a precise scope of a role;
  • Have strong problem-solving and decision-making skills, with demonstrated ability to think creatively and devise solutions to challenging problems;
  • Have the ability to gain the confidence and trust of others through demonstrating and modeling judgement, integrity, and authenticity;
  • Have strong leadership and flexible interpersonal skills to navigate various team working models, to influence without authority, to build partnerships and work collaboratively with diverse teams to meet shared objectives;
  • Have the ability to independently prioritize and work simultaneously on multiple projects, strong attention to detail, and ability to organize and analyze complex information and data;
     
  • Have demonstrated experience leading Compliance operations projects and activities in a matrixed organization; and
     
  • Have excellent written and verbal senior executive-level communication skills.

Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!

Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.

Company

Regeneron is a leading biotechnology company that invents life-transforming medicines for people with serious diseases. Founded and led for 30 years by physician-scientists, our unique ability to repeatedly and consistently translate science into medicine has led to seven FDA-approved treatments and numerous product candidates in development, all of which were homegrown in our laboratories. Our medicines and pipeline are designed to help patients with eye disease, allergic and inflammatory diseases, cancer, cardiovascular and metabolic diseases, infectious diseases, pain and rare diseases.
 
Regeneron is accelerating and improving the traditional drug development process through our proprietary VelociSuite® technologies, such as VelocImmune® which produces optimized fully-human antibodies, and ambitious research initiatives such as the Regeneron Genetics Center, which is conducting one of the largest genetics sequencing efforts in the world.

Stock Symbol: REGN

Stock Exchange: NASDAQ

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Company info
Website
Phone
914-847-7000
Location
Corporate Headquarters
777 Old Saw Mill River Road
Tarrytown
New York
10591
United States

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