Associate Director-Director, Regulatory Affairs: Alternative Resources Company

ASSOCIATE DIRECTOR-DIRECTOR, REGULATORY AFFAIRS

Position Overview:

Responsible for the organization, preparation and submission of NDA for the assigned project

Responsible for the preparation and submission of IND/CTA and maintenance, in compliance to regulations, for the assigned project

Responsible for post-approval maintenance of NDA

Responsible for providing strategic regulatory support for product development under the assigned project.

Essential Job Responsibilities/Primary Activities :

Directly involved in the preparation (content) of NDA submission to FDA including finalization of summaries, ISS/ISE and other critical components.

Directly responsible for the preparation of draft labeling and maintenance in the post-approval phase.

Represent Regulatory Affairs in the NDA task force for the assigned project and provide guidance to the multifunctional team concerning strategic decisions and FDA interactions.

Direct the preparation (content) of regulatory submissions in support of the assigned project including INDs, IND amendments, safety report, annual report, etc.

Draft the strategic correspondences/documents for FDA submission including meeting request, briefing document, pediatric development plan, first-track designation request, etc.

Interact with the Consulting groups, as needed, to accomplish the tasks

Interface with the corporate functional lines, particularly with clinical, biostatistics, and marketing in early and late stage product development

Responsible for coordination with Regulatory CROs for CTA activities, if applicable

Participate in the creation, review, and revision of the standard operating procedures and work instructions.

Performs other departmental duties as assigned

Qualifications:

Demonstrated hands-on experience in successful NDA preparation (content) and submission, eCTD experience is a plus, previous experience in drafting and maintenance of labeling, demonstrated thorough knowledge of intent, meaning, interpretation and application of FDA regulations; in-depth understanding of ICH requirements; proven track record of understanding on clinical trial design issues as well as non-clinical and clinical -pharmacology aspects of drug development; excellent written and oral communication skills; prior leadership experience, 5-10% travel may be required

Required: B.S./M.S. (life science), 5-10+ years of drug regulatory experience, recent NDA submission, review process, and approval experience,

.Preferred: Ph.D. or Pharm.D., Regulatory Affairs Certification (RAC), knowledge of electronic submission, Ex-US regulatory submission experience,

Additional Information:

Ability to think strategically and develop regulatory strategy for product development programs

Ability to interact with external consultants and key-opinion leaders in strategy development sessions

Ability to work cohesively with a cross-cultural global development team

Ability to handle multiple priorities and mange time-line in a fast-pace environment

Ability to handle electronic submissions

Career Map Framework General Profile:

Is recognized as an internal thought leader and external expert in own discipline

Anticipates internal/external scientific/professional and regulatory issues; recommends process/product improvements

Solves unique and complex problems with broad impact on the business

Contributes to the development of the business

Leads global project teams to achieve milestones and objectives

Career Map Framework Dimensions:

Scientific/

Professional

Expertise

Has depth and/or breadth of expertise in own discipline and broad knowledge of others

Has expertise in leading edge theories, techniques, technologies

Anticipates internal/external scientific/professional issues; recommends process, product improvements

Contributes to the development of the business

Regulatory/

Compliance

Facilitates the corporate response to regulatory and compliance issues

Problem Solving

Solves unique and complex problems with broad impact on the business

Customer Focus

Develops innovative services, technologies or processes that address current and future customer problems or needs

Impact

Influence

Presents complex ideas, anticipates objections; persuades others to adopt a different point of view

Decision making

Makes decisions that impact the business strategy

Resource

Management

Project

Management/

Coordination

Leads project teams (for global) to achieve milestones and objectives; may create/initiate teams

Financial

Management

Monitors and provides input into costs/budgets for group-wide or global projects