Pharmaceutical Clinical Associates, LLC
-
NE Jersey,
NJ
Duties and Responsibilities
Within therapeutic areas of responsibility:
¿Coordinates interaction of his/her direct reports with regulatory agencies. Provides support to staff in communications with agencies. Has established relationships with agencies. Maintains corporate credibility with agency officials.
¿Maintain a vigilance of proposed changes and new regulatory legislation. Evaluate the impact of proposed changes and devise strategies and to ensure efficient regulatory functions. Provide regulatory assessments and conducts regulatory due diligence for new opportunities
¿Insure optimal acceptable regulatory strategies for worldwide compliance and submissions, from development through marketing, including advertising, promotion, and labeling, in an environment committed to the efficient and aggressive development of new drugs for patients
¿Develop and implement regulatory strategies for new products, product improvements, new indications;
¿Champion regulatory activities throughout Forest Laboratories. Proactively integrate with preclinical, clin/pharm, clinical development, commercial (marketing), and manufacturing programs to provide regulatory strategy and direction that will accomplish results for worldwide registrations and regulatory product maintenance activities in a positive manner.
¿Help manage and participate in the processes to achieve regulatory agency input into research and development programs.
¿Communicate and negotiate all activities pertaining to his/her assigned therapeutic areas with applicable regulatory agencies to ensure efficient drug development and drug approvals.
¿Ensure that all regulatory documents are prepared in accordance with regulatory guidelines and internal standards and SOPs.
¿Interact with Regulatory Affairs personnel and project team members to define submission logistics and scheduling; coordinate priorities for submissions.
¿Performance management of regulatory therapeutic areas and direct reports
¿Establish, manage, and mentor therapeutic area team.
¿As a member of Regulatory Affairs management team, evaluate functional strengths and developmental areas of the department. Identify and recommend solutions to improve departmental efficiency and effectiveness.
¿Maintain a high level of expertise through reading and attendance at professional seminars, workshops.
¿Exercises outstanding judgment in all areas of responsibility.
¿Maintain fiscal responsibility for department operations and product
Experience and Skills:
Requirements
Education, Licensure & Certifications:
¿Advanced Science Degree with a concentration in healthcare or sciences is required.
¿Regulatory Affairs Certification (RAC) preferred
Required Experience:
¿Demonstrated Regulatory, Quality & Compliance professional with a minimum of 10 years of Pharma / Bio-Pharma experience.
¿Track record of NDA approvals and with contributions to the approval of new products.
¿Extensive experience successfully interacting with regulatory authorities; strong existing relationship with key regulatory agencies
¿Experience with US and International agencies (Europe, Asia, Japan, and South America)
¿A strong understanding of the interface between clinical development and preclinical research.
¿Demonstrated leadership and management capabilities
¿Strong management and leadership skills along with strategic thinking ability.
Technical Qualifications:
¿Knowledge of all relevant pharma regulatory procedures and reporting requirements
¿Experience with document management of INDs, IND Amendments, FDA Briefing Packages, and NDAs. Experience with CTD /e-CTD preparation preferred.
¿Strong technical background including proficiency in Windows, Microsoft Office, and Documentum.
General Qualifications:
¿Energetic, self-motivated, hands on manager; and efficient multi-tasker who is accustomed to working in deadline-focused, high-pressure entrepreneurial environment.
¿Ability to manage multiple simultaneous products/projects.
¿Articulate -- comfortable in both written and oral communications and presentations
¿Provides strategic leadership by determining opportunities and threats through comprehensive analysis of current and future trends. ¿ Strong business acumen
¿Proactive, disciplined, organized, and detail-oriented.
¿Demonstrates consistent logic, rationality, and objectivity when identifying significant problems and opportunities.
¿Creative problem solver with the ability to establish systems and define standard practices.
¿Displays high level of integrity by remaining consistent in terms of what he/she says and does in terms of behavior toward others.
¿Proven track record of establishing, managing, and mentoring cross-functional project teams of technical resources.
¿Fosters high levels of accountability through fair, hard-hitting performance-management system. Measures performance thoroughly.
¿Willing team player capable of working collaboratively with colleagues in their department and in all functions
¿High degree of presence and authority without arrogance; represents the department, company, and partnerships with professionalism and credibility. Strong predisposition toward customer service.
Additional Information:
Job Level: Executive
Number of Openings: 1
Years of Experience: More Than 10 Years
Level of Education: Masters Degree
Salary: TBD
Starting Date : TBD
Email Job To A Friend
Pharmaceutical Clinical Associates is always accepting employment inquiries from professionals interested in our opportunites. If you are interested in career opportunities at Pharmaceutical Clinical Associates please use our online resume formto apply. Pharmaceutical Clinical Associates is an Equal Opportunity Employer.
NE Jersey, NJ
NE Jersey, New Jersey
|
|
|
