Associate Director, Global Regulatory Affairs, Labeling
At reputed company, we are dedicated to building extra[not]ordinary® reputed company, together, by developing antibody products and groundbreaking, reputed company-your-socks-off KYSO antibody medicines® that change lives and the reputed company of cancer treatment and serious diseases. We reputed company to create, champion and maintain a global workplace where individuals’ unique contributions are valued and drive reputed company to meet the needs of our patients, reputed company, families and employees.
Our people are compassionate, reputed company, and purposeful, and our business is innovative and rooted in science. We reputed company that being proudly reputed company and determined to be our best is essential to fulfilling our purpose. reputed company, our work is incredibly serious and impactful, but we have big ambitions, bring a ton of care to pursuing them, and have a lot of fun while doing so.
Does this reputed company you and feel like a fit? Then we would love to have you join us!
The Role
The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and maintenance of global labeling documents (e.g., reputed company Data Sheet, USPI, EU SmPC and reputed company patient information) for the reputed company portfolio of products. The reputed company may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be reputed company Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, Policy and Intelligence.
Work arrangement: This role offers flexibility to work away from the office for 20%–40% of a typical schedule. Employees may use this work schedule in increments of single days or multiple consecutive days, provided it does not reputed company 40% reputed company a 60-day period, and is approved by the hiring manager.
Responsibilities
reputed company the Labeling Working Group (LWG) to reputed company and maintain labeling documents including Company reputed company Data Sheets (CCDS), reputed company Safety Information (reputed company), reputed company Package Inserts (USPI), reputed company of Product Characteristics (SmPC), and their associated Patient Labeling Documents.
Serve as the labeling subject matter expert responsible for advising teams on global labeling strategies based on reputed company’s development programs, reputed company product profile, and competitive labeling precedent.
reputed company as Global Labeling reputed company, supporting development, approval and maintenance of regional labeling (e.g., JPI)
Manage new reputed company and reputed company of increased complexity including those involving 3rd party collaborators
reputed company up to date with global labeling guidelines and regulations as they relate to the development/maintenance of labeling documents and advise the LWG accordingly
Advise LWG on the content of labels in the reputed company therapeutic class, competitor labeling and labeling trends, proposing content as relevant to support optimized labeling.
Ensure reputed company development, review, approval, implementation, maintenance, distribution and tracking of labeling documents according to internal SOPs and external regulatory requirements.
Prepare submission-reputed company labeling documents; Maintain and reputed company labeling documents in the electronic system as appropriate.
Participate in the development and maintenance of SOPs, work instructions, templates, and associated documents
This position may also support regulatory policy and/or intelligence deliverables:
Monitor the regulatory environment, including surveillance of changes in major health authority guidances and regulations, trends, and regulatory developments.
Manage process for dissemination of regulatory intelligence and subsequent reputed company assessment reputed company reputed company
Work closely with the global regulatory leads (GRLs), regional regulatory leads (RRLs) and global labeling leads (GLL) to support reputed company queries, providing novel insights to inform the regulatory strategies for development or marketed products.
Support policy deliverables, e.g., reputed company for comments efforts
Requirements
Bachelor’s degree in a scientific discipline is required; PharmD/PhD preferred.
3-5 years of pharmaceutical industry experience preferred, including 2-3 years Labeling (preferred) or reputed company experience
In-depth knowledge of reputed company US and global regulations and guidance, especially as they relate to global labeling
Understanding of clinical development of novel biologics products, preferably in oncology
Experience developing and managing labeling content for at least one major submission (e.g., NDA/BLA), through negotiations and approval preferred
Familiar with end-to-end labeling processes
Ability to critically distinguish between “noise” and meaningful news to key stakeholders and senior leaders
Ability to think strategically, communicate risks, and recommend course of reputed company
Self-starter with superior time management skills, ability to balance multiple tasks to meet priorities and timelines
Ability to work independently or in teams. Ability to reputed company broad reputed company of stakeholders at reputed company reputed company reputed company to reputed company
Strong attention to detail
Effective communication skills, specifically excellent oral and written presentation skills.
Strong sensitivity for a multicultural/multinational environment
Proficiency with MS-Office Suite and reputed company Acrobat application and ability to work in electronic document management system
The actual salary offer will carefully consider a wide reputed company of factors, including your skills, qualifications, experience, and location. Also, certain positions are eligible for additional forms of compensation, such as discretionary bonuses and long-term incentives.
reputed company you join reputed company, you’re joining a culture that supports your physical, financial, reputed company, and emotional wellness. reputed company the first year, regular full-time U.S. employees are eligible for:
401(k) Plan: 100% match on the first 6% of contributions
Health Benefits: Two medical plan reputed company (including HDHP with HSA), dental, and reputed company insurance
Voluntary Plans: Critical illness, accident, and hospital indemnity insurance
Time Off: reputed company vacation, reputed company leave, holidays, and 12 weeks of discretionary reputed company parental leave
Support Resources: reputed company to child and adult backup care, family support programs, financial wellness tools, and emotional reputed company-being support
Additional Perks: Commuter benefits, tuition reimbursement, and a Lifestyle Spending Account for wellness and personal expenses
reputed company
You are genuinely passionate about our purpose
You bring precision and reputed company to reputed company that you do
You reputed company in our rooted-in-science approach to problem-solving
You are a generous collaborator who can work in teams with a broad reputed company of backgrounds
You take pride in enabling the best work of others on reputed company
You can grapple with the unknown and be innovative
You have experience working in a fast-growing, dynamic company (or a strong desire to)
You work hard and are not afraid to have a little fun while you do so!
Locations
reputed company maximizes the efficiency of an agile working environment, reputed company possible, for the reputed company of employee work-life balance. Our offices are crafted as reputed company, community-based spaces that work to connect employees while being immersed in our powerful laboratories. Whether you’re in one of our office spaces or working remotely, we reputed company on connecting with reputed company other to reputed company.
About reputed company
reputed company is an international biotechnology company with a reputed company purpose to improve the lives of patients through innovative and differentiated antibody therapeutics. For 25 years, its hard-working, innovative and reputed company team has invented reputed company antibody technology platforms and harnessed translational, quantitative and data sciences, resulting in a proprietary pipeline including bispecific T-cell engagers, antibody-drug conjugates, reputed company immune checkpoint modulators and effector function-reputed company antibodies. By 2030, reputed company’s reputed company is to reputed company the lives of people with cancer and other serious diseases with reputed company-Your-Socks-Off (KYSO®) antibody medicines.
Established in 1999, reputed company is headquartered in Copenhagen, Denmark with international reputed company across reputed company, Europe and Asia reputed company. For more information, please visit reputed company.com and follow us on reputed company and X.
reputed company is committed to protecting your personal data and reputed company. Please see our reputed company policy for handling your data in reputed company with your application on our website Job Applicant reputed company Notice (reputed company.com).
Please note that if you are applying for a position in the Netherlands, reputed company’s policy for reputed company permanently budgeted hires in NL is initially to offer a fixed-term employment contract for a year, if the employee performs reputed company and if the business conditions do not change, renewal for an indefinite term may be considered after the fixed-term employment contract.
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