Bachelor's degree from an accredited institution; science focus preferred.
1+ years of experience in pharmaceutical or medical device Regulatory Affairs.
Proven track record with 1-3 years of relevant regulatory experience.
Experience in Advertising and Promotion in Regulatory is required.
Ability to effectively collaborate with cross-functional teams including Medical, Legal, and Marketing.
Responsibilities
Identify product-specific A&P issues and collaborate with teams to propose solutions.
Advise on risk/benefit strategies for regulatory matters to assist clients in decision-making.
Oversee implementation of regulatory strategic objectives with minimal supervision.
Act as Regulatory representative on brand teams and Review Committees for commercial and medical materials.
Provide guidance to internal teams to enhance product development and promotion strategies.
Contribute A&P expertise to labeling for new and supplemental drug applications.
Develop product-specific regulatory strategies to mitigate risks and maximize stakeholder value.
Benefits
Participation in company employee benefit programs.
Opportunities for professional development and growth.
Collaborative work environment with cross-functional teams.
Full Job Description
Job title: Manager Regulatory Affairs Advertising and Promotion
Location: Cambridge, MA / Morristown, NJ
Main Responsibilities:
Identifies product-specific or therapeutic area A&P issues and works with other teams to propose and implement solutions.
Identifies different strategies for addressing issues; advises of risk/benefit of each and assists clients with making sound business decisions with the understanding of the potential risk/benefits with respect to intervening regulatory matters.
Oversees and bears responsibility for the successful implementation of regulatory strategic objectives and projects with minimal supervision.
Active participant and Regulatory representative on brand teams and Review Committees (RC) for commercial and medical materials, respectively.
Provides guidance and feedback to internal Sanofi constituencies (commercial groups, R&D) to maximize the competitive impact of product development as well as ultimate promotion, advertising, and reimbursement. Provides input to the Global organization on domestic regulatory strategies for in-line products through life cycle management programs.
Contribute A&P expertise to the development of optimal labeling on new and supplemental new drug applications.
Provides product-specific Regulatory strategies to mitigate risk; works in conjunction with brand team management to provide advice and risk/benefit analysis to maximize value to stakeholders.
Performs other duties as assigned.
About You
Basic Qualifications:
Bachelor's degree from an accredited four-year college or university; Science focus preferred, but not require
Work Experience Required:
1+ Years experience in the following areas:
Experience within pharmaceutical or medical device Regulatory Affairs.
Successful track record with ideally 1-3 years relevant regulatory experience.
Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.
Experience in Advertising and Promotion in Regulatory required.
Dealt effectively with cross-functional groups, which may include Medical, Legal, Marketing etc.
Knowledge, Skills and Equivalent Experience:
Knowledge and understanding of complex medical and scientific subject matter.
Ability to work well within cross-functional teams.
Demonstrates solid oral communication and writing skills.
Understanding of the U.S. pharmaceutical marketplace, 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.
Develops and proposes 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 to gain acceptance of ideas or plans.
Can build collaborative internal networks to obtain cooperation.
Unquestionable ethics, professional integrity and personal values consistent with the Sanofi values.
Is able to balance 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 manage workload. Is able to multi-task well.
Deals with people in an honest and forthright manner representing information and data accurately.
The salary range for this position is: $122,250.00 - $176,583.33
All compensation will be determined commensurate with demonstrated experience. Employees may be eligible to participate in Company employee benefit programs, and additional benefits information can be found here.
About Sanofi
Sanofi is a global pharmaceutical company that specializes in the research, development, and manufacturing of prescription drugs and vaccines. The company operates in over 170 countries and has a diverse portfolio of products that includes treatments for diabetes, cancer, cardiovascular disease, and rare diseases. Sanofi is committed to improving global health and has a strong focus on innovation and sustainability. The company has received numerous awards for its research and development efforts and is recognized as a leader in the pharmaceutical industry.
