Director, Regulatory Affairs

Position Summary:

Provide an overview of the role, including job scope / responsibilities, impact, decision authority, problem solving, level of influence, etc.

The Director of Regulatory Affairs will oversee, direct, and manage the day-to-day activities of the Regulatory team at Rising Pharmaceuticals, Inc.  This position plays a key role in assuring that the proper regulatory pathways are established at the stages of both business development and commercial operations.  Additionally, the position requires a willingness to “roll up your sleeves” and engage hands on in substantive regulatory work, as well as the ability to effectively work collaboratively with other departments.  The Director will work closely with the Business Development, QA, Supply Chain, Sales, and Operations departments. The Director of Regulatory Affairs will actively manage Rising’s Regulatory team, including 4 direct reports.
Essential Duties & Responsibilities: Regulatory
• Responsible for achieving department objectives in preparation and submission of Abbreviated New Drug Applications and New Drug Applications, including amendments, supplements, annual reports, and related submission documents, obtaining information from all appropriate departments or outside suppliers.
Responsible for interpreting regulatory guidance and proposing regulatory strategy to expedite approval of drug applications in accordance with agency requirements.
Leverage a strong understanding of FDA guidance applicable to drug applications, and the ability to independently develop and execute efficient regulatory strategies.
• Reviews FDA correspondence regarding submissions and initiates necessary actions to ensure timely responses.
• Ensures communication with Drug Master File (DMF) holders concerning technical requirements and any changes or updates to be filed with FDA. Reviews and/or provides guidance on the creation/ revision of documentation from other departments for content and appropriateness for use in regulatory submissions.
• Serves as an internal SME on FDA matters for the management team, and business development, sales, supply chain and legal departments.
• Directs the development of new product pipeline approval submissions to meet FDA regulatory review requirements.
• Maintains approved ANDAs in compliance with FDA regulations with emphasis on strict maintenance of all annual reports and change controls.
• Responsible for final release to the market and field alert/recall decisions for ANDA owned products.
• Lead the organization in providing CMC advice on product development through dossier filing, pre- and post-submission communications with FDA, controlled correspondences, pre-ANDA meetings, pre-submissions meeting, citizen petitions, dispute resolutions, responses to deficiencies, post-approval changes, due diligences on product licensing / acquisition, and participation at FDA meetings.
• Manage technical review of dossier that strive for Acceptance to File (ATF) first time, avoid any Refuse-to-Receive (RTR) comments from FDA, and confirm robustness assessment of the dossier, thereby leading to a meaningful prediction of FDA approval timelines.
• Anticipates future regulatory changes, identifies risks and impact to business success, and takes action to limit the effect on Rising’s business.
• Maintains an up-to-date knowledge on regulatory matters and advises senior management of potentially significant changes and risks.
• Is the primary point of contact for FDA and other local regulatory agencies and leads quality and regulatory teams to prepare for inspections and audits.
• Establishes and monitors compliance with a periodic review cycle to ensure guidelines/SOPs documents are up-to-date and reflect current practice and escalates to senior management when appropriate.
• Creates implements and conducts training for all employees and provides advice regarding FDA inspections and responding to investigators.
Essential Duties & Responsibilities: Leadership
• Provides planning and leadership to staff by ensuring that appropriate structures, policies, competencies, and values are developed.
• Provides leadership in developing and implementing regulatory strategies and processes.
• Discusses issues and ideas with internal and external customers with an open mind and even temper, while maintaining confidentiality as the situation requires.
•Exhibits a strong continuous improvement mindset and able to perform duties which are non-standardized and require the ability to adapt to change.
• Ensures that interfaces between Regulatory and other departments, particularly QA, BD, Supply Chain, Operations, and Sales are managed optimally.
• Is key contributor to business development and sales teams providing compliance input to influence selection of partners and business decisions.
• Interfaces with customers regarding regulatory issues in support of business development and sales opportunities.
• Detailed understanding of generic product development, dossier-filing, and approval.
• Manages decision making and conflict resolution regarding compliance related activities.
Position Requirements:
Required: M.S. or higher in related fields
Required: • Minimum 10-15 years’ experience in Regulatory Affairs, specifically in Generics

• Extensive experience of all phases of the drug development process in regulatory affairs, including for projects with little or no precedence

• Proven experience of leading regional development, submission, and approval activities in local region(s).  Capable of organizing and executing successful milestone meetings and with track record of successful relationships with one or more health authority

• Extensive knowledge of clinical trials (where relevant to generics) and licensing requirements

• Ideally also a significant external network at least into other generic/API/pharma companies and recognized as an expert broadly or in specific areas of regulatory affairs

Company / Industry Related Knowledge:
Generic Pharmaceutical knowledge
Job Specific Competencies:
• Keen analytic, organization and problem-solving skills
• Excellent teamwork, communication, analytical and leadership skills.  A “team player” attitude is a must
• Must have the ability to interact effectively at all levels of the organization, as this position will have significant exposure to senior management
• Strong interpersonal skills and experience in effectively communicating key data to internal departments and customers
Physical Requirements: N/A

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