Job Type: Contract
Job Length: 1 Year (Renewable)
Job ID: 4698
Top 3 Must Haves
1. Previous regulatory experience as a Global lead or (less desired) as the US/EU lead
2. Comfortable with change and making decisions in ambiguous situations (we will have a lot of change to manage and someone who relies on processes to be effective will likely be uncomfortable in the current environment)
3. Scientific background with some clinical development experience (in any function)
The Global Regulatory Lead is responsible for developing and directing the global regulatory strategy, objectives, policies and programs pertaining to development and marketing of drug and/or biological products. This role includes the lead regulatory responsibility for support of global registration and life cycle support, and includes the leadership of regulatory strategy for multiple projects that extend globally (United States, EU, ROW, etc.) coordinating support via a Global Regulatory Strategy Team composed of core regulatory support functions.
25% • Designs and implements regulatory strategies to obtain, maintain product investigative and marketing applications, and extend product registrations. Single point of contact and accountability for regulatory and leads the regulatory subteams as well as represents regulatory on key internal decision making teams such as PSTs and GDTs.
25% • Functions as the global regulatory lead for assigned projects, working with a cross-departmental group of regulators as part of Global Regulatory Team, including CMC, Operations, Labeling, International, Advertising/Promotion and Intel/Policy to drive global regulatory strategies.
• Provides proactive guidance to internal groups based on technical and regulatory knowledge towards development of strategic and tactical plans. Identify and assess regulatory risks associated with product development for assigned projects.
25% • Leads the development of strategic plans and tactical implementation leading to the creation and submission of Regulatory documents, e.g., INDs, NDAs/BLAs, CTAs, MAAs, supplemental NDAs/BLAs and other relevant regulatory filings.
5% • Serves as corporate liaison with regulatory Health Authority (HA) agencies to develop effective professional relationships as well as our positive company image.
• Effectively leads key meetings with HAs to ensure full discussion of issues and opportunities.
5% • Provides guidance to all appropriate departments to assure compliance with applicable regulations.
• Remains knowledgeable about current regulations and guidance, interprets and notifies appropriate personnel and works with regulatory policy/intel as appropriate
• Makes recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed.
5% • Actively trains/mentors junior staff; provides broader guidance on regulatory interpretation to staff.
5% • Makes recommendations for regulatory department operating procedures. May be responsible for creating and reviewing SOPs as needed.
5% • May supervise a changing number of Regulatory Affairs Associates.
• Actively trains/mentors junior staff; provides broader guidance on regulatory interpretation to staff.
• BS, BSc, MS, MSc, PhD, PharmD, J.D., M.D. in science or healthcare preferred or equivalent relevant experience.
• Generally has at least 8-15 years of Regulatory Affairs experience, including equivalent experience in the biopharmaceutical industry. The regulatory experience should be broad (across the life cycle of pharmaceutical products and across main regions such as the US, EU, Japan and Canada) to ensure appropriate leadership and mentoring for regulatory staff.
• 2-5 years of management experience preferred
• Demonstrated ability to routinely accept empowerment from senior leadership to proactively resolve issues and identify and champion opportunities toward optimal regulatory strategies and implementation.
• Works on abstract problems across functional areas of the business. Identifies and evaluates fundamental issues for major functional areas through assessment of intangible variables.
• Develops corporate and/or organizational policies and authorizes the implementation of these policies.
• Responsible for the successful operation of activities of major significance to the organization.
• Represents the organizational unit as prime internal and external contact for GRA
• Strong competency in understanding regulatory requirements and emerging regulatory landscape associated with the HA(s), supported by the local staff.
• Ability to read, analyze and interpret scientific and technical information, as well as regulatory documents.
• Experienced in responding to inquiries or complaints from HAs.