The Everest Group


*A division of The Everest Search Group, Inc., Los
  Angeles, CA
*The Everest Search Group Inc., Lake Tahoe, NV

Ranked Top 200 of America's Best Executive Search Firms in 2017 by Forbes

Director Global Regulatory Affairs Lead Immunology


Our client is an innovative leader in the biopharmaceutical industry with more than 30,000 employees globally, more than $20 Billion in revenue, and a diversified product portfolio focusing on a variety of therapeutic areas including Neurology, Immunology, and Oncology.

PURPOSE OF THE ROLE
• Ensure the development, implementation, and communication of global regulatory strategy (as outlined in the Regulatory Strategy Document (RSD) and in accordance with the integrated Development Plan (iDP)) for the assigned product from the full development Decision Point to the post-authorization phase
• Ensure an understanding of the external regulatory competitive environment to adapt product regulatory strategy accordingly
• Ensure top quality across all Health Authority submissions and planning for production of dossier(s) in cooperation with Regulatory Informatics and Submission Management (RISM)
• Lead Health Authority and regulatory advisory board meetings to support the project and its associated submissions
• Provide an assessment of regulatory opportunities to potentially enhance the development pathway and of regulatory risks for the various options for regulatory development, as well as potential measures for risk mitigation

KEY TASKS & RESPONSIBILITIES
• The GRL is defined as a role and not a position; this role is taken by regulatory experts who have functional responsibilities in a defined therapeutic area and have a position reporting to a Therapeutic Area Head, located in one of the company’s development hubs.
• This role is specific to critical development projects in full development up to registration and the early post-authorization phase. As such the business impact is substantial and is reflected in the qualifications, expertise and experience required for the role.
• Manage the Regulatory Sub-Team (RST)
• Coordinate with RST members representing the Regions to develop a global regulatory strategy that is consistent enough to meet Health Authority expectations in all key target markets
• Align with the RST member from Global Regulatory & Scientific Policy over the external regulatory competitive environment to adapt product regulatory strategy accordingly
• Establish key submission timelines (e.g., NDA/MAA), in consultation with RST members
• Coordinate with RST members representing CMC, Center of Excellence Product Information and RISM to ensure access to necessary content and functional contacts for dossier(s)
• Provide strategic oversight to the DTF and DTF Lead (from RISM)
• Develop structure for high-level dossier content (i.e., Submission Content Plan (SCP)) and Submission Strategy Synopsis in conjunction with the DTF to meet Health Authority requirements and to incorporate company product and development plans
• Align with senior management and key stakeholders on dossier content
• Sign off on SCP upon completion
• Ensure GRA-aligned regulatory input is incorporated into development decision making at the Global Project Team level. He/she is responsible for communicating global regulatory strategy and defending GRA positions to internal teams.
• Develop and implement global regulatory strategies to meet Health Authority expectations in target regions according to the RSD for the product concerned.
• Lead the Regulatory Sub-team (RST) based on the process defined through the Top Outcomes Project 2 (TOP2) towards the successful submission and approval of marketing authorization applications, as well as other strategic global regulatory submissions. The GRL is the lead for any interactions with Health Authorities, but can define a regional deputy or delegate. However, he/she will be accountable for being the voice of the company with Health Authorities.
• The GRL prepares and implements regulatory advisory boards with a primary focus on critical target markets such as, but not limited to, the EU, US, China and Japan.
• Ensure an understanding of the external regulatory competitive environment globally in order to adapt product regulatory strategy accordingly.
• Ensure top quality across all regulatory submissions.
• Plan for production of dossier(s) with the required content and quality to support the proposed label and product approval. The GRL provides strategic oversight to the Dossier Task Force (DTF) and RISM on dossier content.
• Represent the company at external meetings and on pharmaceutical industry committees.
• Lead the project reviews of the product concerned within GRA&QA, based on the process defined by TOP2.
• Leads the benefit / risk assessment of the product concerned, as called for in the iDP.
• Involve R&D QA in the development of project operational plans..

REQUIREMENTS
• Degree in a Life Science or related discipline, higher degree preferable (PhD, MSc, MBA)
• Excellent spoken and written English.  
• Minimum of 10 years pharmaceutical industry experience and 8 years regulatory experience
• Experience in preparation and management of successful NDA/BLA submissions in US and/or EU; experience with Japan and China submissions is desirable
• Experience liaising with FDA and leading teams to achieve successful Health Agency interactions
• Experience with the clinical trial phase of development, e.g. IND/CTA requirements
• Development and preparation of successful regulatory strategies and ability to contribute to the development and writing of a regulatory strategy document
• Experience leading a project with development activities in at least two regions
• Experience as a strong regulatory advisor to regulatory professionals as a key member of the RST
• Experience speaking at external meetings and acting as a company representative on pharmaceutical industry committees is highly desirable

PERSONAL SKILLS & COMPETENCIES
• Excellent written and spoken communication skills in English
• Good interpersonal skills
• Attention to details
• Ability to lead and work in teams
• Awareness of current trends in regulatory affairs
• Business orientation
• Good organizational and planning skills
• Ability to think strategically

 Equal Employment Opportunity

The Company is an Equal Employment Opportunity employer.

No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law.

This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment.

Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.