Ardelyx is a publicly traded commercial biopharmaceutical company founded with a mission to discover, develop and commercialize innovative first-in-class medicines that meet significant unmet medical needs. Ardelyx’s first approved product for the treatment of irritable bowel syndrome with constipation (IBS-C) is available in the United States and Canada. Ardelyx is developing XPHOZAH® (tenapanor), a novel product candidate to control serum phosphorus in adult patients with CKD on dialysis, which has completed three successful Phase 3 trials.

Regulatory Affairs Manager

This position will be responsible for contributing to proactively managing CMC aspects of one of more global clinical programs including overseeing preparation and submission of global CMC submissions, ensuring the CMC content is complete, well-written and meets all relevant requirements. This position will contribute to the evaluation of proposed manufacturing changes for regulatory impact to ongoing and existing filings and providing strategic regulatory guidance for optimal implementation of changes. In this role, research and interpreting global CMC regulations will be required and providing regulatory guidance to the various cross functional areas such as Quality, Manufacturing, Process Development and other functional groups. This role will represent the RA CMC function on assigned cross-functional project teams developing excellent relationships with all cross functional teams, contract manufacturing organizations and corporate partners.

Responsibilities:

• Charter and manage submission teams through all stages of submission execution, leading to delivery of high-quality, on-time regulatory submissions. Ensure adequacy of required documentation for regulatory submissions (IND, CTA, NDA and MAA) for US and international applications.
• Contribute to the development of stage-specific CMC regulatory content, including marketing applications for US, Europe and selected global markets, with an eye towards sound product lifecycle principles.
• Liaise with corporate partners, to make sure e- US regulatory submission is consistent with US regulatory submissions and notify them of potential changes that may impact their regulatory filings
• Maintain awareness of and expertise in FDA and ICH guidelines related to regulatory topics.
• Provide interpretation and communication of Regulatory Intelligence as appropriate with guidance.
• Work with CMOs to ensure accuracy of information provided to regulatory authorities.
• Participate in meetings with cross-functional teams on regulatory related issues.
• Develop and maintain knowledge of regulatory requirements and industry trends independently and with line manager.
• Assess change controls for US regulatory impact and record assessments in Veeva Quality System.
• Work with SMEs to provide timely responses to CMC questions from regulatory agencies or partners with guidance.
• Write, review, and qc CMC sections of regulatory submissions as needed.
• Write, review and qc CMC responses to questions from regulatory agencies with guidance.
• Contribute to departmental process improvements related to the RA function.
• Foster a collaborative environment and contribute to a positive, dynamic, high-energy organization.
• Other duties as assigned.

Requirements:

• Bachelor’s Degree or/and graduate level with scientific background
• 2-5+ years in regulatory affairs in the pharmaceutical industry
• Experience in FDA CMC submissions utilizing eCTD format and electronic submissions.
• Strong CMC background. Must have strong analytical skills and ability to communicate across all levels of the organization. Clinical experience a plus.
• Strong oral and written communication skills, interpersonal skills, as well as strong organizational skills and ability to understand technical processes and requirements.
• Ability to interpret and understand regulatory and cGXP requirements and apply to regulatory submissions and job duties.
• Proficient in Microsoft Suite products, experience with VEEVA RIM preferred.
• Ability to independently manage timelines in a project team environment.
• Travel as needed to attend company meetings, and domestic internal and external training seminars and conferences.

Work Environment:

• Corporate office based (in Fremont, CA) or possible hybrid position with potential as needed travel to Ardelyx corporate offices.

The anticipated annualized base pay range for this full-time position is $96,784 to $118,292. Ardelyx utilizes industry data to ensure that our compensation is competitive and aligned with our industry peers. Actual base pay will be determined based on a variety of factors, including years of relevant experience, training, qualifications, and internal equity. The compensation package may also include an annual bonus target and equity awards, subject to eligibility and other requirements.

Ardelyx also offers a robust benefits package to employees, including a 401(k) plan, equity incentive plans, health plans (medical, prescription drug, dental, and vision) and basic life insurance and disability, as well as up to 10 hours of paid vacation per month, and at least 10 paid holidays.

Ardelyx is an equal opportunity employer.