Regulatory Affairs Associate Director/Director

PDL BioPharma is a leader in the discovery, development, and marketing of innovative therapies for acute-care environments. Our current product pipeline includes six breakthrough investigational compounds for the treatment of cardiovascular disorders, cancer, and other serious illnesses.

Pioneering science, strong commercial products, and a rich development pipeline define PDL BioPharma. And our success is based on one key factor—our people. At PDL BioPharma, every employee directly contributes to the development and delivery of innovative therapies that help make real a difference in people's lives. We foster a goal-oriented and entrepreneurial culture where teamwork, commitment, and initiative are valued and rewarded.

Products. Pipeline. People. PDL BioPharma invites you to be part of the future of biotechnology.

We are proud to be an equal opportunity employer.



Job Description
Job Responsibilities: This position will be managing the day-to-day regulatory activities of assigned projects for compounds under late stage development. These activities include acting as the regulatory representative on development/launch teams and in collaboration with joint partnerships, developing and planning regulatory submission strategy, coordinating the preparation of submissions to regulatory agencies, assisting drug safety personnel with adverse event reporting, and conducting regulatory intelligence activities. Interacts with regulatory agencies and ensures the timely preparation of scientifically valid submissions.
The Associate Director/Director will manage one or more Regulatory Affairs Staff. Principal duties and responsibilities include managing all regulatory activities for assigned projects, including representation on the project development teams; supervising regulatory document assembly, reviewing and submission to regulatory agencies in the US and ex-US, while ensuring that the compilation and transmittal of regulatory submissions are completed within defined time schedules and meets established standards; managing the Regulatory Affairs Associate/Manager in the planning, preparation, coordination of technical review and input, and assembly of regulatory submissions (e.g., INDs/CTAs, information amendments, BLAs, eCTDs, DMFs); representing the Regulatory Affairs Department in interdepartmental meetings and in collaborations; participating in meetings and interacting with members of the project team and sub-teams to convey regulatory requirements and develop a strategy to meet corporate goals; interacting with regulatory agencies and ensures the timely preparation of scientifically valid submissions; collecting and evaluating regulations and guidance documents for their impact on assigned development programs. Communicating regulatory issues to functional areas and transmits regulatory concerns from functional areas to senior management; assisting in the establishment and maintenance of Regulatory Affairs operating procedures for the department; actively pursues the improvement of regulatory knowledge by studying the US Code of Federal Regulations and guidance documents as published by FDA, as well as those generated by ex-US regulatory agencies (e.g., EMEA, ICH workgroups), and utilizes this knowledge in the performance of the functions of this job.



Required Skills
Candidate must have a Bachelors or advanced degree in scientific/life-sciences or related field with at least 8-10 years of pharmaceutical industry experience and 6-8+ years of direct regulatory affairs experience; strong knowledge of regulations/guidelines governing development of pharmaceuticals is required; must have experience with small molecule or biological products and working with international regulatory agencies is highly desired; excellent interpersonal skills; must be detailed oriented; good writing skills; work well under pressure; computer skills and working knowledge in software such as MS Word, Excel, FileMaker Pro, and other software programs, as necessary. Experience with electronic submissions is highly desirable.