Senior Manager/Associate Director, Regulatory Affairs
Our client is a biotechnology company specializing in regenerative medicine. They have asked us to assist them in a search for a Senior Manager/Associate Director, Regulatory Affairs.
Major tasks and responsibilities include:
We seek candidates with the following qualifications:
- Is responsible for regulatory submissions for products. Ensures that regulatory submissions are complete, properly formatted, and comply with applicable regulatory requirements.
- Drives project teams to achieve timely submission goals, while effectively interacting with all functional areas involved in the project goal.
- Researches regulatory and scientific information to develop regulatory strategies, writes regulatory assessments and provides input on technical and regulatory issues to guide internal teams.
- Interacts with government agencies and regulatory authorities, as necessary, to facilitate submission review and product approvals, maintains compliance and communicate pertinent information. Plans and participates in meetings with FDA and provides regulatory support for inspections by government and other regulatory authorities.
- Partners with other functional areas to deliver solutions to project goals and execute tactics that further business objectives in an effective and compliant manner.
- Interacts with outside consulting groups and vendors to manage activities necessary for completing key initiatives.
- Provides Regulatory Affairs support for Class II and Class III medical devices and biologic and products, including applications submitted to the FDA and other regulatory agencies.
- Works with cross functional collaborators and external consultants. Advises on regulatory and scientific issues related to the development of these products.
- Participates in industry organizations and alliances to influence regulatory policy making and decisions that impact company operations.
- Leads and manages complex issues with multiple competing priorities that have a direct impact on operations and opportunities. Provides organization and prioritization to align with business needs.
- A Bachelor’s degree in a scientific discipline is required.
- Must have at least five years of industry experience with at least three years of increasing responsibility in Regulatory Affairs.
- Requires a thorough working knowledge of biologic development processes and FDA regulatory requirements for biotechnology products in the US.
- Must have successfully submitted regulatory filings to the FDA and other regulatory agencies.
- Must have experience with technical aspects of product development and manufacturing.
- Strong oral and written communication skills, and negotiation skills are required.
- Must be willing to set and drive aggressive project timelines.
- Must be capable of strategic thinking and proposing innovative solutions to regulatory problems.
- Must be a team player who listens effectively.
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.
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