Manager, Global Regulatory Sciences

Pay Range: $70 - $75

Schedule Notes: Hybrid role (3 days onsite) Ideally a temp to perm position. initially approx. 6 months but has the opportunity for extension and conversion down the line.

Qualifications:

Bachelor’s degree in scientific discipline; advanced scientific related degree a plus
4 years or more in drug development; direct Regulatory experience is a plus
Experience in oncology/rare diseases drug development a plus
Ideally experienced in filing and managing INDs to FDA
Working knowledge of drug development process and US regulatory requirements required; knowledge of EU, Canada, ROW, and post-marketing regulatory requirements a plusAs a Manager in Global Regulatory Sciences team, this role will have responsibility supporting and implementing the development of global regulatory strategies to advance and maintain company mast cell disease portfolio. Reporting to the Director of Global Regulatory Sciences, this individual will primarily provide regulatory support of both an operational and strategic nature to the Global Regulatory Lead(s) and cross-functional teams responsible for the development, registration and maintenance of company compounds in mast cell disease indications. The individual will also ensure effective communication and constructive working relationships with external collaborators and regulatory authorities.

Responsibilities:

Support line manager with the day-to-day management of regulatory aspects of at least one clinical development program
Responsible for relevant submissions for assigned program(s).
Represent the Global Regulatory Sciences function on cross functional teams
Support line manager in developing and implementing long and short-term product regulatory strategies/plans
Plan for and lead preparation efforts for health authority meetings
Provide guidance to external vendors and consultants as needed
Monitor the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs



Capabilities:

Excellent interpersonal and communication skills. Ability to establish and maintain professional and productive working relationships
Well organized, with an attention to details and capable of managing multiple deliverables
A collaborator who communicates in an open, clear, complete, timely and consistent manner
At home in a results-driven, highly accountable environment where you can make a clear impact
A team player, who listens effectively and invites response and discussion
Flexible and adaptable in ambiguous situations
Must be proficient in Microsoft WORD, Excel, PowerPoint as well as SmartSheet and Adobe Acrobat