Director, Regulatory Affairs International - United States
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- Our company is the world leader in delivering therapeutics that provide meaningful advances to patients who live with serious and life-threatening rare genetic diseases. We target diseases that lack effective therapies and affect relatively small numbers of patients, many of whom are children.
- These conditions are often inherited, difficult to diagnose, progressively debilitating and have few, if any, treatment options.
- Our company will continue to focus on advancing therapies that are the first or best of their kind.
- Our company's Development Sciences group is responsible for everything from research and discovery to post-market clinical development.
- Development Sciences involves all bench and clinical research and the associated groups that support those endeavors.
- Our teams work on developing first-in-class and best-in-class therapeutics that provide meaningful advances to patients who live with rare diseases.
- Come join our team and make a meaningful impact on patients’ lives.
- Manage a US-based team that supports regulatory activities for the Canada, LATAM, MEA CIS and APAC regions, ensuring strategic alignment with Commercialization efforts, and support other product activity as needed.
- In conjunction with our company’s regional leads and experts, develop understanding of regional laws, regulations, guidance, and global regulatory and political developments; develop and communicate regulatory strategies to execute complex multi-functional filings and anticipate potential gating factors.
- Leads and/or participates on interdisciplinary regulatory teams responsible for defining and implementing regulatory strategy, including plans to submit Marketing Applications globally. Provides regulatory leadership on cross-functional development teams.
- Manages and mentors associate-level regulatory professionals to achieve regulatory objectives in line with individual development and corporate goals.
- Lead/participate on interdisciplinary regulatory teams in establishing global regulatory strategy for commercial products
- In conjunction with regional leads and experts, oversee planning, preparation, and submission of marketing applications to support LATAM, MEA CIS and APAC regions
- Provide strategic regulatory insight to the project team
- Manage and mentor RA International team based in the US
- Communicate with regulatory consultants regarding product development plans
- Present to RA leadership team to obtain agreement on global regulatory plans and priorities
- Minimum of 10 years regulatory experience. Clinical development a plus.
- Minimum of 5 years of experience in managing regulatory staff
- Managerial ability
- Direct and develop staff
- To guide and implement international Marketing application strategies
- Work within a matrix environment
- Well-developed leadership and project management skills, including demonstrated cross-functional communication, interpersonal and influence management skills
- Scientific and technical expertise, including the ability to develop robust global regulatory plans covering all phases of drug development
- Skilled in gathering information pertaining to good decision making, negotiation and communicating decisions and action. Ability and sensitivity to work with many cultures and across time zones. In many cases competing objectives will have to be harmonized and reconciled to achieve the overall objectives
- Demonstrated leadership in defining novel approaches to product approvals globally including dealing with regulatory issues and hurdles and navigating health authority requests
- Proven track record of managing critical projects as a part of an interdisciplinary team
- Proven record in gaining marketing application approvals globally in line with agreed timelines
- Proven track record of successfully interacting and negotiating with regulatory health authorities
- Thorough understanding of global regulatory environment and relevant drug development regulations and guidelines
- Outstanding interpersonal and communication (written and verbal) skills
- Effective task planning and coordination abilities
- Strong analytical regulatory skills to interpret regulatory data and make critical decisions;
- Ability to focus on multiple issues at one time, and to organize and direct diverse activities in a changing environment often under time pressure
- Rare disease experience is preferred
- US and international experience preferred
- Biologics experience preferred
- Previous work with global CRO’s a plus
- Bachelor's degree preferably in a science/life sciences with 10+ years of regulatory experience described above within the biotechnology or pharmaceutical industry. Clinical and nonclinical emphasis a plus