Objective:

The incumbent will be responsible for developing and implementing regulatory strategy leading to successful registration and life-cycle management of unique and technologically complex products.  This individual will provide regulatory leadership and a sense of urgency to cross-functional teams responsible for global programs and ensure effective communication and constructive working relationships with business partners and representatives of the US Food and Drug Administration.

 

Essential Job Duties:

·        Develops and directs innovative and effective regulatory strategies in support of assigned Apicore portfolio, pipeline and therapeutic areas.

·        Serves as advisor on regulatory issues for both marketed and pipeline products; actively collaborates with management and cross functional colleagues within Apicore

·        Serves as an influential and well respected spokesperson with staff at FDA, including leading meetings and preparations to facilitate expedited approval of original applications and supplements

·        Provides expert regulatory affairs review, input, opportunity and risk assessment into confidential, strategic and often complex due diligence initiatives

·        Provides input into draft FDA Guidances and policies, working closely with the Apicore team.  Serves as Apicore’s regulatory affairs representative on relevant U.S. trade association teams as assigned

·        Ensures exemplary behavior, ethics and transparency within the company and with regulatory agencies

·        Submits Drug Master Files (DMF) and Abbreviated New Drug Applications (ANDA) as required

·        Performs all required updates to filed documents and responds to all regulatory requests including DMF and ANDA deficiencies and customer inquiries

·        Works with Apicore staff to write technical and regulatory documents

·        Consistently analyzes and reviews company documents and procedures to ensure compliance with all regulatory needs and requirements

·        Develops and implements necessary procedures for changes in regulatory requirements and provides training as needed

·        Supervises regulatory staff and performs  annual evaluations

·        All other duties as assigned

 

Experience & Education:Minimum Bachelor Degree Required; Advance Degree Preferred.  10 – 15 years in pharmaceutical industry regulatory affairs

 

Knowledge:

·        Strong knowledge of drug development and regulatory policy for ANDAs and NDAs; excellent scientific and business judgement

·        Experience providing strategic regulatory advise for the global development of products through all stages of development including pre-approval and marketed compounds

 

Skills & Abilities:

·        Ability to manage complex issues and coordinate multiple projects simultaneously.

·        Ability to build team relationships and collaborate in a global team environment at all levels of the organization.  Adept at change management

·        Proven track record practicing sound judgment as it relates to risk assessment

·        Highly conversant and knowledgeable of new and emerging regulations and guidances.  Understanding of GMPs, GLPs and GCPs; solid understanding of where to seek and how to interpret regulatory information.

·        Excellent leadership skills

·        Exceptional oral and written communication capabilities

·        Advanced computer knowledge in MS Office programs

·        Excellent organizational abilities and superior attention to detail

·        Must have high level of interpersonal skills

·        Ability to maintain high level of confidentiality at all times

·        Possesses strong analytical and problem solving skills

·        Excellent time management skills and project management skills