Manager, Global Regulatory Sciences

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 the company's 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 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

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Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.