Associate Director, Regulatory Affairs - Redwood City, CA | Biospace
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Associate Director, Regulatory Affairs

Relypsa Inc.

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Location:
Redwood City, CA
Posted Date:
8/9/2017
Position Type:
Full time
Job Code:
541
Salary:
DOE
Required Education:
Other
Areas of Expertise Desired:

Job Description

Company Overview

Relypsa, Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of polymeric medicines for patients with conditions that are often overlooked and undertreated and can be addressed in the gastrointestinal tract. The Company's first medicine, Veltassa® (patiromer) for oral suspension, was developed based on Relypsa's rich legacy in polymer science. Relypsa was founded in 2007 and, in September 2016, became a Vifor Pharma company.  More information is available at www.relypsa.com.

Product Overview

Veltassa® (patiromer) for oral suspension was approved in October 2015 for the treatment of hyperkalemia, a condition defined as elevated blood potassium levels that can cause abnormal heart rhythms and even sudden death. A potassium binder, Veltassa® is the first new medicine for the treatment of hyperkalemia in more than 50 years and is the first commercialized medicine resulting from Relypsa’s polymer technology platform. Relypsa is committed to ensuring that people living with the burden of hyperkalemia have access to Veltassa®.

Position Summary:  

The Associate Director, Regulatory Affairs will be responsible for performing or managing key regulatory activities for the department, including clinical trial support, safety reporting, labeling, and required filings such as IND and NDA annual reports.

The responsibilities include working closely with functional areas and project teams to support further product development and global approval. The individual must possess a thorough knowledge of U.S. and international regulations and guidance governing drugs in all phases of development. Strong communication and management skills are required. The position level is dependent on experience and qualifications.

Position Responsibilities include:

•   Create and maintain regulatory timelines and track deliverables to timelines to ensure that regulatory submission timelines are met
•   Participate in the development of regulatory strategy and provide strategic input and regulatory advice to the project teams on both development program and lifecycle opportunities
•   Proactively identify project issues and implement appropriate regulatory strategies to mitigate risks
•   Develop and/or review regulatory documents to ensure that all submissions are of high quality
•   Provide critical review of documents (SOPs, protocols, and reports) related to clinical, drug safety, nonclinical or manufacturing, as necessary
•   Interface with functional areas (Clinical, Nonclinical, CMC, Commercial, Drug Safety) to identify and obtain information required for regulatory submissions
•   Manage IND/CTAs, NDA/MAA, annual reports, and information amendments in multiple countries for multiple protocols
•   Manage the preparation and filing of regulatory applications
•   Interface with global regulatory authorities and consultants as needed
•   Support the preparation and conduct of Agency meetings as necessary to support regulatory filings and applications, including preparation and coordination of briefing packages
•   Maintain knowledge of current global rules, regulations, and guidances governing drugs and biologics in all phases of development, as well as knowledge of therapeutic area
•   Develop and maintain current knowledge of US regulation of labeling and industry standards for labeling and communicate requirements to others as needed.
•   Direct the labeling control process for tracking, implementation and regulatory submission of changes to existing labeling.
•   Facilitate Labeling Review Committee activities.
•   Participate on Regulatory Affairs sub teams for activities related to the development of labeling for regulatory submissions.

Requirements

•   BS or higher degree in science or law, or equivalent, with at least 7 years of experience in Regulatory Affairs
•   Experience in preparation and submission of CTAs and amendments
•   Attention to detail with solid coordinating, task planning and time management skills
•   Experience in managing, mentoring and developing direct reports
•   Outstanding verbal, written and interpersonal communication skills
•   Ability to work independently and in a team environment, with strong leadership, negotiation and influencing ability
•   Strategic thinker and problem-solver capable of providing advice, identifying risks, decision making, and implementing plans and risk mitigation strategies
•   Thorough understanding of global drug development regulations and guidelines.
•   Proven ability to successfully manage major submissions and critical projects to deadlines
•   Extended knowledge of science and data of assigned products and how that translates into labeling language.
•   Extended knowledge of competitive landscape and how other companies are dealing with similar issues in labeling and promotion.

As an employee of Relypsa, you will actively contribute to the development of potential new products. We provide opportunities for all employees to collaborate, offering visibility and opportunity to directly contribute to the companies' success. We realize that our strength and competitive advantage lie with our people. We support our employees in a number of ways to foster a healthy working environment, meaningful work, diversity and inclusion, mobility, networking and work-life balance. Our competitive compensation and benefit programs reflect Relypsa’s high regard for our employees.

NOTE:  This position summary is not intended to be all-inclusive. Employee may perform other related duties as negotiated to meet the ongoing needs of the organization.

Relypsa is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, sex, color, religion, sexual orientation, gender identity, national origin, protected veteran status, or on the basis of disability.