Role OverviewWorking with the team leader, develop global regulatory strategy in development and through life cycle management. Lead regulatory dossier submissions to global and/or FDA. Work with cross-functional groups to define and manage contributions to submissions.
What You Will Do
Write regulatory documents, review core documents to support IND/BLA/NDA, and participate in or lead regulatory interactions with FDA. Contribute to cross-functional rapid response teams to respond to Clinical Trial Application queries.
Why It Might Be a Fit
This role requires a solid scientific background, 4-8 years of pharmaceutical industry experience, and significant experience in regulatory affairs. The ideal candidate will have thorough knowledge of the drug development process, IND and NDA process, and experience in preparing FDA submissions.
Requirements
- PhD, MD, Pharm.D., BS or MS in regulatory science
- 4-8 years pharmaceutical industry experience
- Significant experience in regulatory affairs
- Thorough knowledge of the drug development process, IND and NDA process
- Experience in preparing FDA submissions
- Strong experience with US Regulatory submissions and dossiers
- Inter-dependent partnering skills, team-oriented and ability to influence outcomes
- Experience in successfully leading teams
- Ability to innovate, analyze and solve problems with minimal supervision and attention to detail
- Demonstrates ownership of results within (and beyond) area of responsibility
- Sets clear and high expectations and holds self and others accountable for decisions and results achieved
- Looks for opportunities for continuous improvement
- Strong team player, using both internal and external resources to execute regulatory activities
- Communicates opinions, facts and thoughts with clarity, transparency, and honesty
- Experience applying project management techniques within teams
- Experience in effectively managing meetings
- Experience with developing and documenting regulatory strategies in coordination with clinical plans and marketing objectives
- Demonstrated ability to facilitate issue resolution and conflict management, to negotiate and influence others
- Ability to drive quality decision making, to organize and prioritize tasks and negotiate
- Demonstrated ability to coordinate global activities
Benefits
- Health Coverage: Medical, pharmacy, dental, and vision care
- Wellbeing Support: Programs such as BMS Well-Being Account, BMS Living Life Better, and Employee Assistance Programs (EAP)
- Financial Well-being and Protection: 401(k) plan, short- and long-term disability, life insurance, accident insurance, supplemental health insurance, business travel protection, personal liability protection, identity theft benefit, legal support, and survivor support
- Paid Time Off
- Flexible time off (unlimited, with manager approval)
- 11 paid national holidays
- 160 hours annual paid vacation for new hires with manager approval
- 11 national holidays
- 3 optional holidays
- Unlimited paid sick time
- Up to 2 paid volunteer days per year
- Summer hours flexibility
- Leaves of absence for medical, personal, parental, caregiver, bereavement, and military needs
- Annual Global Shutdown between Christmas and New Years Day
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