Sr Director, Regulatory Affairs, Oncology Products / PHA16267 Job in Bridgewater 08807, New Jersey Us

Sanofi-aventis is facing the future and leading the way as the 3rd largest pharmaceutical company in the world and number 1 in Europe. Backed by a world-class RD organization, sanofi-aventis is developing leading positions in seven therapeutic areas: cardiovascular disease, thrombosis, oncology, diabetes, central nervous system, internal medicine, and vaccines. Embrace this opportunity to join a diverse and talented group of individuals championed to take on innovation and change in our rapidly expanding organization.

Position Description:

Summary:
In one or more therapeutic areas, considered a resident expert in U.S. Regulatory Affairs Marketed Products (US RAMP) on promotional, labeling, product defense, and development strategies. Contributes to the maintenance and enhancement of strategic relationships with customers and directs activities to influence the external regulatory environment in accordance with US RAMP objectives. Has a primary focus of 6-12 months. Responsible for oversight of regulatory review of promotional and other material. Develops and implements regulatory strategies for marketed products within their therapeutic products area. Develops direct reports for future leadership roles. Provides input into the global organization for labeling strategies of marketed drugs. Primary therapeutic product liaison with FDA.

Responsibilities:
• Responsible for oversight of day-to-day activities.
• In conjunction with the department head, recommends and contributes to the development of strategic objectives across assigned therapeutic areas.
• Contributes to the maintenance and enhancement of strategic relationships with customers.
• Ensures established tactical objectives are consistent with overall strategic goals.
• Possesses primary responsibility/accountability for the successful implementation of tactical objectives.
• Informs decisions that directly affect strategic objectives and operational success.
• Ensures that the regulatory environment is continually monitored for new regulations/guidances and applicable enforcement activities.
• Oversees staff implementation of U.S. Regulatory strategies (e.g., submissions, product defense, labeling development, DDMAC enforcement, clinical trial support, FDA contacts).
• Provides development opportunities for direct reports that contribute to US RAMP staff development.
• Establishes and develops key internal relationships with RD and Regulatory Development to foster open communication and teamwork.
• Provides input and advice into local implementation of global promotional campaign strategies.
• Functions as the first level of Review Committee dispute resolution.
• Assures alignment and consistency in US RAMP policy application within and across therapeutic products; taking into account the totality of product-related and company activities.
• Ensures therapeutic product relationships with FDA are established and maintained.
• Demonstrates required competencies on a consistent basis.
• Demonstrates company values on a consistent basis.
• Performs other duties as requested.

Management Responsibility:
• This position has direct reports.
• This position manages a team of people.
• This position does not have budgetary responsibility.

Qualifications:

Education:
• Bachelor's Degree and equivalent experience required.

Experience:
• Experience within pharmaceutical or medical device Regulatory Affairs
• Successful track record with ideally 7-10 years relevant regulatory experience.
• Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.
• Experience managing others required.

Professional Skills:
• Extensive knowledge and understanding of complex medical and scientific subject matter.
• Possesses comprehensive breadth of technical knowledge in regulatory affairs and ensures dissemination of this knowledge to others throughout the organization.
• 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 therapeutic product 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