at Merck in Millsboro, Delaware, United States
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.
We are seeking a Growth and Improvement minded Associate Regulatory Affairs Director that can help drive our Strategic Operating Priorities.
+ Invent | Pursue the Most Promising Internal and External Science to Address Significant Unmet Medical Needs
+ Execute | Prioritize Resources Behind Our Key Growth Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business)
+ Adapt | Develop Our People, Culture and Business Model to Evolve with a Dynamic Landscape
+ Diverse Talent | We are committed to providing an inclusive and welcoming environment with supporting leadership behaviors because having a high-performing, engaged workforce is critical to our ability to deliver innovative solutions to patients and customers around the world
+ Values and Standards | Our Steadfast Commitment to Our Values and Standards will Continue to Guide Us as We Take on New Opportunities and Will Always be Fundamental to Our Success – They are a Competitive Advantage for Us
Summary, Focus and Purpose
+ The Associate Regulatory Affairs Director is a lead role responsible for managing direct reports and ensuring regulatory filings of animal health products in pursuance of licensure and marketed animal health products are submitted in compliance with applicable USDA regulations.
+ Work Independently and as a Team member with Integrity | Precision | Accomplishment | Motivational Ambition | Respect | Inclusion
+ Provide USDA regulatory guidance and regulatory strategy with interdepartmental teams for pre and/or post license of US Biologicals | Serve as RA lead for designated R&D species and licensed products
+ Serve as an Alternate Liaison with the USDA for pre and/or post-regulatory responsibilities to include submissions and communications with the USDA, internal company departments and international permittees | Communicate as appropriate to direct in line manager communications or concerns
+ Review and prepare regulatory submissions in support of new licenses or licensed biologicals with the USDA | Prepare Standard International Dossiers and review registration documents for export markets where applicable
+ Supervise direct report personnel with priorities, development and performance management
+ Bachelor’s degree in Scientific, or related areas of study with ten years regulatory experience…..OR, a Master’s degree in Scientific or related areas of study with five years regulatory experience, in the vaccine or pharmaceutical industry
Experience | Skills | Knowledge
+ Strong working knowledge of USDA requirements and regulations relating to manufacturing and research and development of biological vaccines
+ Efficient and effective time and project management skills
+ Principled people, communication and leadership skills for involvement with cross departmental teams
+ Antibody Therapeutics experience desired
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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, generally Tuesday, Wednesday and either Monday or Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as “remote”.
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