CAssociate Director/ Director, Regulatory Affairs

About The Company

The text of the first paragraph describing Dren Bio and its technologies is preserved as provided. For more information, please visit our website at www.drenbio.com.

About The Company

The text of the second paragraph describing Dren Bio and its technologies is preserved as provided. For more information, please visit our website at www.drenbio.com.

Function

Level

Associate Director/ Director

Location: San Carlos, CA

Reporting Manager

SVP, Regulatory Affairs

About The Opportunity

Dren Bio is seeking an experienced and talented individual who will provide regulatory strategic guidance on development programs, as well as oversee the writing, preparation and finalization of regulatory submissions and communications with various world-wide health authorities. The position requires a hands-on, self-starter who works well in partnership with internal colleagues and external partners. This person will also be responsible for advising on regulatory compliance matters.

Title, compensation and scope of duties will be tailored to the successful candidate's experience.

Role And Responsibilities

• The Associate Director/Director of Regulatory Affairs is accountable for the deliveryof regulatory strategy for designated programs at DrenBio.
• Proactively develop and provide regulatory guidance on strategies for optimal drugdevelopment and marketing authorization in the United States and other identifiedregions.
• Contribute to team and corporate product development decisions in the context ofapplicable laws, regulations, and guidance from health authorities.
• Lead all regulatory communications with and submissions to the US-FDA and otheridentified health authorities (eg, INDs/CTAs, expedited designations (eg,fast-track, breakthrough, prime), orphan drug applications, pediatric investigationplans, development/scientific advice, marketing applications).
• Oversee timely writing, preparation, and finalization (including actively writingregulatory documentation) of scientifically valid/accurate submissions that arecompliant to the applicable health authority requirement.
• Develop and maintain strong relationships with the FDA and other identified healthauthorities to foster close partnerships geared towards optimizing productdevelopment and registration.
• Contribute to establishing and administering internal regulatory policies andprocedures to achieve best practices work processes.
• Stay abreast of newly issued regulatory laws and guidance as well as technicalpublications, articles, and abstracts to promptly identify possible impact orimprovements to product programs.
• Participate in professional and industry organizations to follow regulatory trends,influence development of regulations and guidance, and develop relationships torepresent the interests of the company.
• Work with Quality and other departments to ensure data accuracy and integrityrelating to health authority submissions and reporting requirements.
• Participate in corporate partnership efforts.

Education, Experience And Qualification Requirements

• Bachelor's degree in a scientific field (eg, Clinical, Biological, Mathematical) isrequired; an advanced degree is a plus.
• Minimum of 10 years for Associate Director or 12+ years for Director in regulatoryaffairs in Biotechnology or comparable experience.

Core Competencies, Knowledge And Skill Requirements

• Good background in biological/physical science and the ability to apply thatknowledge to regulatory issues.
• Prior regulatory submissions experience in biotechnology product development,particularly with investigational new drug applications in the US, Europe, andAustralia.
• Experienced with regulatory agency interactions and in preparing teams for meetingswith health authorities.
• Good writing skills and able to effectively describe complex situations in regulatorydocuments.
• The ability to be a productive team member, capable of making effective,knowledgeable contributions.
• Must be well-organized and capable of handling multiple priorities.
• Proven ability in creative problem solving and the ability to eliminate roadblocks todevelopment.
• Possess a strong interpersonal skill that fosters a proactive approach to workingcross-functionally on development teams.

Salaries, Benefits And Other Employee Perks

Dren Bio strongly believes in investing in, and rewarding, its employees. This philosophy is embodied in the Company's total rewards program, which includes competitive cash compensation, equity incentive awards, and employer sponsored benefit offerings. The base pay range for this position at commencement of employment is expected to be between $170,000 and $220,000 per year.

At Dren Bio, pay ranges are determined by role, level(s), and location. The range displayed in this job posting reflects the minimum and maximum new hire pay for candidates located across all United States job markets. Within the range, individual pay will be determined by work location and additional factors, including job-related skills, experience, and relevant education or training.

During the hiring process, Dren Bio's Human Resources department can share more about the specific pay range based on the market location of the candidate.

Employment Practices

Dren Bio is an equal opportunity employer. Employment decisions are based on merit and business needs. Dren Bio will not discriminate against any job applicant because of race, color, national origin, ancestry, gender, sexual orientation, age, religion, creed, physical or mental disability, gender identity, medical condition, pregnancy, marital status, veteran status, or any other characteristic protected by federal, state or local law.

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