about 1 month ago
This individual will report to the Senior Vice President for Global Regulatory Affairs and Strategy, and will be accountable for the efficient and compliant execution of all Regulatory Operations, Regulatory Writing, and Labeling processes across all products.
This team operates in 40+ countries around the world, and its nearly 900 staff interact daily with hundreds of vendors, contractors, and outsourced workers to execute these strategies and serve companies' patients.
Responsibilities of this role include:
- Accountable for all aspects of Regulatory Labeling, Global Regulatory Operations, and Global Regulatory Writing
- Represent the team functions to Senior Management
- Provide timely input on strategies, decisions, and implementation plans related to the team functions
- Define departmental goals and objectives, and lead team to achievement of them
- Provide strategic vision to guide the continuous improvement of team activities, delivering year-over-year productivity savings
- Partner with cross-functional leadership to resolve conflicts and prioritize activities in alignment with Company and teams strategic goals and imperatives
- Provide coaching, mentoring, and development of staff
- Recruit and retain regulatory professionals and assist in the recruitment of talented team and Company staff
- Advance Knowledge Management as a core competency and driver of efficiency/success across the team
What we expect of you
We are all different, yet we all use our unique contributions to serve patients. The Regulatory professional we seek is a Leader with these qualifications.
- Doctorate degree and 6 years of regulatory affairs experience OR
- Master's degree and 10 years of regulatory affairs experience OR
- Bachelor's degree and 12 years of regulatory affairs experience AND
- 6 years of managerial experience directly managing people and/or leadership experience leading teams, projects, programs or directing the allocation of resources
- MBA., PhD, PharmD, Master’s Degree
- 10 years of work experience in life sciences or medically related field, including 7 years of research and development experience in biopharmaceutical or pharmaceutical industry
What you can expect of us
As we work to develop treatments that take care of others, so we work to care for our teammates’ professional and personal growth and well-being.
- Clear and disciplined strategic vision for the future that leverages superior-quality products, operational excellence and top-shelf-talent
- Diverse and inclusive community of belonging, where teammates are empowered to bring ideas to the table and act
- Generous Total Rewards Plan comprising health, finance and wealth, work/life balance, and career benefits
I manage a range of other permanent and freelance positions for a broad portfolio of clients (Biotech, CRO and Pharma). If the above role isn’t for you but you’d nevertheless like to discuss your options in the market, I’d welcome a confidential discussion by phone or email. Contact Antoinette Miller at 619-326-3648 or at firstname.lastname@example.org