Manager, Regulatory Affairs
Our client is a precision therapy company. They have asked us to assist them in a search for a Manager, Regulatory Affairs.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Manages day-to-day regulatory activities to support multiple early-stage global programs.
- Determines the content of relevant sections of project/product specific documents submitted to regulatory agencies and ensures that these documents meet high scientific standards and regulatory requirements.
- Provides robust regulatory advice and plans to the various project teams and advisory bodies to ensure that the business needs comply with regulations and/or regulatory advice received from the agencies.
- Develops and implements long and short-term product regulatory strategies/plans.
- Represents the Regulatory Sciences function on cross functional teams such as Clinical Trial Teams.
- Provides regulatory guidance to external programs vendors as needed.
- Monitors the development of new regulatory requirements or guidance documents and advise product teams of the impact on the business or development programs.
- A Bachelor’s degree is required. An advanced scientific related degree a plus.
- Requires at least two to three years of direct regulatory affairs experience.
- Experience in oncology/rare diseases drug development a plus.
- Experience in filing INDs, EU CTAs is ideal. Experience of post marketing submissions to FDA or EMA is a plus.
- Requires a working knowledge of the drug development process and US regulatory requirements. Knowledge of EU, Canada, ROW, and post-marketing regulatory requirements is a plus.
- Must have excellent interpersonal and communication skills and the ability to establish and maintain professional and productive working relationships.
- Must be well organized, with an attention to details and capable of managing multiple deliverables.
- Must be a collaborator who communicates in an open, clear, complete, timely and consistent manner.
- Must feel comfortable in a results-driven, highly accountable environment where you can make a clear impact.
- Must be a team player, who listens effectively and invites response and discussion.
- Requires flexibility and adaptability in ambiguous situations.
- Must be proficient in Microsoft Word, Project, PowerPoint, and Adobe Acrobat.
If interested, please apply directly to this job posting. No calls please. Include your daytime phone number and we will contact you confidentially or reply to your email.
Fairway Consulting Group is included in Hunt Scanlon’s list of Top 50 Healthcare & Life Sciences Search Firms
and Forbes' list of Top 200 Best Executive Recruiting Firms