? High Salary! Director, US Regulatory Affairs – Advertising and Promotion Position Available In Morris, New Jersey
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Job Description
Job Description:
Job Title:
Director, US Regulatory Affairs•
Advertising andPromotion Location:
Cambridge, MA or Morristown, NJ About the jobAre you ready to shape the future of medicine? The race is on tospeed up drug discovery and development to find answers forpatients and their families. Your skills could be critical inhelping our teams accelerate Progress. We are an innovative globalhealthcare company with one purpose: to chase the miracles ofscience to improve people’s lives. We’re also a company where youcan flourish and grow your career, with countless opportunities toexplore, make connections with people, and stretch the limits ofwhat you thought was possible. Ready to get started?
MainResponsibilities:
- Makes decisions, provides direction andoversight for the day-to-day activities for assigned products,departmental activities, and direct reports.
- In conjunction withthe Sr. Director/Product Support Head, imparts senior regulatoryguidance and advice during issues management activities; providesoversight and guidance for Rapid Response Teams; functions as thetherapeutic product expert for Region NA, A&P.
- Continuallymonitors the regulatory environment, interprets new regulations,guidance’s, and enforcement activities/trends and evaluates theimpact on external environments and the business.
- Develops andimplements regulatory strategies for marketed products within theirproduct area and mentor and develop others in executing strategy.
- Establishes and develops key internal relationships withtherapeutic product leaders in R D and Corporate to foster opencommunication and teamwork.
- Assures alignment and consistency inRegion NA, A&P policy application within and across therapeuticproducts; takes into account the totality of product-related andcompany activities.
- Assists in ensuring product supportrelationships with FDA are established and maintained.
- Providesinput into the global organization for labeling strategies ofmarketed drugs.
Demonstrates significant autonomy in carrying outassigned duties and responsibilities.
About You Experience:
- 8years of experience within pharmaceutical or medical deviceRegulatory Affairs
- Successful track record of relevantadvertising & promotion regulatory experience
- Dealt effectivelywith cross-functional groups, which may include Medical, Legal,Marketing, etc.
- Experience managing others is preferred
Education:
- Minimally, possess a Bachelor’s degree from anaccredited four-year college or university in a relevant LifeSciences discipline or specialization
Additional Skills:
- Understanding of the U.S. pharmaceutical marketplace andfamiliarity with medical terminology. Understands issues, problems,and opportunities by comparing data from different sources to drawconclusions and then can choose a course of action or develop theappropriate solution.
- Regularly demonstrates the ability toparticipate in a more strategic capacity in the functional area andday-to-day decision-making process.
- Extensive knowledge andunderstanding of complex medical and scientific subject matter.
- Can build networks to obtain cooperation without relying onauthority. You will also have the ability to work well withincross-functional teams.
- Generates innovative solutions in worksituations, trying different and novel ways to deal with workproblems and opportunities.
- Shows ability to use appropriateinterpersonal styles and techniques and can modify behavior to gainacceptance of ideas or plans.
- Able to establish priorities andtimelines to effectively self-manage workload. Is able tomulti-task exceptionally well.
- Deals with people in an honest andforthright manner representing information and data accurately. WhyChoose Us?
- Bring the miracles of science to life alongside asupportive, future-focused team.
- Discover endless opportunitiesto grow your talent and drive your career, whether it’s through apromotion or lateral move, at home or internationally.
- Enjoy athoughtful, well-crafted rewards package that recognizes yourcontribution and amplifies your impact.
- Take good care ofyourself and your family, with a wide range of health and wellbeingbenefits including high-quality healthcare, prevention and wellnessprograms and at least 14 weeks’ gender-neutral parental leave.
Sanofi Inc. and its U.S. affiliates are Equal Opportunity andAffirmative Action employers committed to a culturally diverseworkforce. All qualified applicants will receive consideration foremployment without regard to race; color; creed; religion; nationalorigin; age; ancestry; nationality; marital, domestic partnershipor civil union status; sex, gender, gender identity or expression;affectional or sexual orientation; disability; veteran or militarystatus or liability for military status; domestic violence victimstatus; atypical cellular or blood trait; genetic information(including the refusal to submit to genetic testing) or any othercharacteristic protected by law.
GD-SA LI-SA
LI-Onsite vhd Allcompensation will be determined commensurate with demonstratedexperience. Employees may be eligible to participate in Companyemployee benefit programs, and additional benefits information canbe found here.