Senior Director, Regulatory/QA 8/8/2016
JOB DESCRIPTIONAPPLY Pernix Therapeutics is a specialty pharmaceutical business with a focus on acquiring, developing and commercializing prescription drugs primarily for the U.S. market. The Company targets underserved therapeutic areas such as CNS, including neurology and psychiatry, and has an interest in expanding into additional specialty segments. The Company promotes its branded products to physicians through its Pernix sales force, uses contracted sales organizations to market its non-core, cough and cold products, and markets its generic portfolio through its wholly owned subsidiaries, Macoven Pharmaceuticals, LLC and Cypress Pharmaceutical, Inc. The Corporate HQ is based in Morristown, New Jersey.
The Senior Director of Regulatory will support senior management in all US Regulatory Activities proving regulatory strategic leadership and tactical direction to facilitate guidance and assessment in development, approval, and life cycle management.
* Provide proactive regulatory strategic updates and guidance to senior management.
* Provide strategic and tactical direction and regulatory guidance for development, submissions and interaction with FDA, product labeling, REMS and associate medication guides, and compliance-related activities.
* Ensure that knowledge/training of the regulatory systems and procedures is current.
* Provide oversight and serve as a discipline reviewer for PRC.
* Oversee quality assurance and audit.
* Oversee pharmacovigilance and label-review committee.
* Liaison responsible for communication with FDA and other health authorities, including Agency meetings as required
* Participate in multidisciplinary project teams to provide regulatory guidance and communicated regulatory goals.
* Supervises regulatory staff with the planning, preparation and submission of all regulatory documentation.
* Evaluate emerging regulations and changing regulatory landscape for impact and provide strategic advice.
* Provide the above in to be in support of corporate objectives and in maintaining corporate compliance.
QUALIFICATIONS AND JOB REQUIREMENTS
The successful candidate will be a Bachelors, in Business Administration or Life Science with 10-12 years of Pharmaceutical Industry experience with at least 7 in Regulatory and 3 in a supervisory or leadership role.
Key requirements include:
* Direct experience in serving as a liaison with the FDA, leading meetings and other interactions with the FDA.
* Direct experience developing and submitting INDs, IND amendments, NDA supplements, meeting background materials and other materials to FDA.
* Team leadership experience in submitting to NDA.
* Strong decision making history and accountability.
* Leadership experience in interacting with Executive Management team; well organize, adept at planning and in working within interactions with other discipline team.
* MA degree
* Direct experience in outsourcing and overseeing vendors/contractors.
* Therapeutic area or project team leadership role.
* Global development experience.
WORKING CONDITIONS AND PHYSICAL REQUIREMENTS
* This job operates in a professional office environment. This role routinely uses standard office equipment such as computers, phones, photocopiers, filing cabinets and fax machines.
* The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. While performing the duties of this job, the employee is regularly required to talk and hear. The employee frequently is required to stand; walk; use hands to finger, handle or feel; and reach with hands and arms.