Requisition Number: PHA13851
Job Title: Director, Regulatory Product Support
Interest Category: Regulatory Affairs

Interest: Regulatory Affairs

Department: US RAMP

State: New Jersey

City: Bridgewater

Job Description: Summary

In at least one product area, considered the resident expert in U.S. Regulatory Affairs Marketed Products (US RAMP) on promotional, labeling, product defense, and development strategies. Is responsible for decision-making, direction, and oversight of the day-to-day activities of their assigned products, departmental activities, and direct reports in order to meet internal and external customer needs. Develops and implements regulatory strategies for marketed products within their product area. Provides input into the global organization for labeling strategies of marketed drugs. Demonstrates significant autonomy in carrying out assigned duties and responsibilities. Directs the activities and professional development of one or more product support colleagues. Liaises with FDA.

Responsibilities:
Makes decisions, provides direction and oversight for the day-to-day activities for assigned products, departmental activities, and direct reports
In conjunction with the Sr. Director/Product Support Head, imparts senior regulatory guidance and advice during issues management activities; provides oversight and guidance for Rapid Response Teams; functions as the therapeutic product expert for US RAMP
Continually monitors the regulatory environment, interprets new regulations, guidance's, and enforcement activities/trends and evaluates the impact on external environments and the business
Identifies opportunities for coordination across functional barriers to achieve common business objectives
Anticipates the overall impact of regulatory decisions on business over the long term
Assists clients in developing business decisions with consideration of future long term impact
Mentors and develops the professional expertise of US RAMP staff in their product area
Contributes to succession planning through management and development of assigned staff
Assists the Sr. Director/Product Support Head in providing day-to-day oversight and leadership for US RAMP Product Specialists in developing of U.S. Regulatory strategies (e.g., submissions, product defense, labeling development, DDMAC enforcement, clinical trial support, FDA contacts); assists Sr. Director/Product Support Head in setting the strategic direction for US RAMP strategies
Responsible for commercial regulatory input for products in Phase III; collaborates with Global R&D on labeling development and negotiations with FDA; oversees launch activities
Establishes and develops key internal relationships with therapeutic product leaders in R&D and Corporate to foster open communication and teamwork
Functions as the product support representative on the Corporate Core Safety Information team
Assists Sr. Director/Product Support Head in providing input and advice into local implementation of global promotional campaign strategies
Functions as the avenue for review committee dispute resolution as assigned by Sr. Director/Product Support Head
Assures alignment and consistency in US RAMP policy application within and across therapeutic products; takes into account the totality of product-related and company activities
Assists in ensuring product support relationships with FDA are established and maintained
Performs related duties as requested
Demonstrates required competencies on a consistent basis
Demonstrates company values on a consistent basis
Performs other duties as requested

Management Responsibility:
This position may have direct reports.
This position does not manage a team of people.
This position does not have budgetary responsibility.
Requirements: Education:
Bachelor's Degree and equivalent experience required

Experience:
Experience within pharmaceutical or medical device Regulatory Affairs
Successful track record with ideally 8-10 years relevant regulatory experience
Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.
Experience managing others preferred

Professional Skills:
Regularly demonstrates the ability to participate in a more strategic capacity in the functional area and day-to-day decision making process
Extensive knowledge and understanding of complex medical and scientific subject matter
Ability to work well within cross-functional teams
Can demonstrate solid oral communication and writing skills
Understanding of the U.S. pharmaceutical market place and familiarity with medical terminology. Understands issues, problems, and opportunities by comparing data from different sources to draw conclusions and then can choose a course of action or develop the appropriate solution.
Develops collaborative relationships to facilitate the accomplishment of work goals
Generates innovative solutions in work situations, trying different and novel ways to deal with work problems and opportunities
Shows ability to use appropriate interpersonal styles and techniques and can modify behavior to gain acceptance of ideas or plans
Can build networks to obtain cooperation without relying on authority
Unquestionable ethics, professional integrity, and personal values consistent with the sanofi-aventis values
Is capable of managing product support projects on topics specific to the functional area. Is able to balance managing these projects with day-to-day duties, ensuring participation from other members of the department as needed.
Is able to establish priorities and timelines to effectively self-manage workload. Is able to multi-task exceptionally well.
Deals with people in an honest and forthright manner representing information and data accurately

Language:
English