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Objective of the Position:

As 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 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 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

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 plus

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

NOTES:

Ideal candidate would have solid foundational knowledge in early phase drug development, with emphasis on clinical development.

Direct regulatory experience is a plus, but not a requirement.

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