Senior Director of Regulatory Affairs - ROW

Resolvit.com - Remote

RESOLVIT

Bringing Solutions That Make Business Better

Join Resolvit as a Senior Director of Regulatory Affairs - ROW and be part of a creative, forward-thinking team. Our success at deploying skilled, highly knowledgeable experts has landed us on the Inc. 5000 list of America’s fastest-growing companies four times – and we’re just getting started.

As the Senior Director of Regulatory Affairs - ROW, you will manage and develop regulatory staff. You will support the drug development and registration efforts for plant-based biologic products including vaccines, antibodies, and monoclonals across different infectious diseases and therapeutic areas. You will also manage and support the regulatory activities necessary to develop and up-date marketing applications for product registration in all relevant regulatory jurisdictions including ROW. Additionally, you will:

  • Negotiate with ROW regulatory authorities and interface and manage internal subject matter experts and CMOs involved in dossier preparation
  • Be responsible for all labelling and promotional compliance activities
  • Lead, plan, and execute global regulatory post-approval and ROW strategy and submissions for all assigned R&D and marketed products
  • Collaborate with various sub-teams to deliver against corporate timelines and broader corporate objectives in accordance with regulations and guidance
  • Serve as liaison to regulatory authorities
  • Manage, hire, and mentor regulatory staff
  • Ensure regulatory senior management is aligned with strategy, timelines, risks, and mitigations with the goal of presenting a unified regulatory position
  • Identify, review, and establish regulatory affairs SOPs and RA processes for post approval and ROW activities
  • Review and approve global technical documents for regulatory submissions and ensure compliance and alignment with regulatory requirements and strategy
  • Lead special projects in coordination with internal and external stakeholders
  • Coordinate timelines and work with both internal and external stakeholders and/or staff to meet departmental and corporate goals
  • Act as a point of contact for all specific regulatory post-approval and ROW subject matters or topics
  • Represent the department internally on committees and intra-functional projects
  • Identify and implement innovative initiatives in support of corporate objectives
  • Set short-term goals and negotiate with necessary points of contact to achieve them
  • Present key updates to regulations, guidelines, and processes to senior management
  • Oversee the promotional compliance team and negotiate with promotional compliance agencies
  • Oversee the labelling team and negotiate labelling with regulatory agencies
  • Provide analysis, trends, and impact of surveillance of key health authority activities, including key approvals of competitor products and to the promotional compliance and labelling landscape
  • Lead the publishing operations team

What You’ll Need to be Successful:

  • At least 15 years of experience with regulatory drug development of biologic products, including 5 years in vaccines
  • Master's degree in a biological science related field (an advanced degree is highly desirable)
  • Proven leadership and program management experience
  • Expert knowledge of regulatory affairs for biologics within one or more therapeutic areas, preferably infectious diseases
  • Expert knowledge of global regulatory agencies and regulatory submission processes and ability to find material and information
  • Broad background of experience working in pharmaceutical business and prior experience in several areas within regulatory affairs (Global, European, International, Marketing Company or experience at a health authority is required
  • Scientific understanding of the regulatory data requirements including experience with multiple regulatory disciplines (CMC, regulatory intelligence, clinical development)
  • Regulatory experience with approved products, labelling, and promotional compliance
  • Demonstrated experience leading teams to prepare for Major Health Authority interactions (FDA advisory committee meetings, Oral explanations, Scientific Advice, Pre-NDA/BLA, etc.) and attending Health Authority meetings
  • Excellent knowledge of regulatory information system (RIM) and electronic document management system (EDMS)
  • Demonstrated successful publishing experience of complex eCTD submissions
  • Demonstrated understanding of global promotional compliance agencies and submission processes, negotiating skill, and ability to find regulatory material and information
  • Expert understanding of GLP, GMP, and GCP
  • Proven track record of developing and implementing regulatory strategy and of managing complex negotiations with Regulatory Authorities
  • Excellent influencing and negotiating skills

Great Additional Skills:

  • French fluency

Benefits:

At Resolvit, you’ll be given the support you need to grow in your consulting career. In addition to opportunities for advancement, we offer:

  • Medical, dental, and vision insurance
  • Life insurance coverage
  • Long-term and short-term disability coverage
  • 401(k) retirement plan with matching
  • Professional support from our Client & Employee Optimization Specialist

We currently have more than 100 open career opportunities across the country, so be sure to mention the appropriate Job Code with any correspondence!

About Resolvit:

Resolvit is an international technology consulting firm with industry-leading customers in the financial services, high tech, manufacturing, retail, life sciences, and government sectors. Through its partnerships, Resolvit delivers highly impactful, innovative solutions across five core areas: Infrastructure Modernization, Application Development Services, Enterprise Data Management & Analytics, Knowledge & Content Management, and Strategic Staffing.



Posted On: Wednesday, March 10, 2021



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  • It is the policy of Resolvit, LLC to provide and administer employment, training, compensation, promotion, benefits and employment practices without regard to race, color, religion, national origin, ancestry, sex, sexual orientation, age, disability, medical condition, veteran status, marital status, or political affiliation.