Job Role: Regulatory Affairs Associate.
Job Hours: Full-Time
Location: Eagle, Idaho
Salary: Salary commensurate with experience

The Regulatory Affairs Associate participates in the management of all regulatory aspects of pharmaceutical products throughout their lifecycle. Participates in the pharmaceutical regulatory strategy, and managing interactions with various regulatory authorities. Assists in providing directional guidance to the business on how to prepare products for approval and keeps abreast of evolving global regulatory requirements. Assists Regulatory Affairs personnel associated with the Pharmaceutical product lifecycle (which includes but is not limited to Regulatory Product Development, Advertising and Promotion, Labeling, and CMC). Leads and develops personnel to promote compliance with all laws, regulations, or guidance. The major duties and responsibilities will include but are not limited to:

• Assist in the development of global product regulatory strategies for all products
• Assist in the regulatory functions in relation to drug development and product approvals, consistent with agreed upon time lines
• Assists and manages interactions with Regulatory Authorities
• Provide regulatory support to other functions (e.g., Quality, Compliance) during Regulatory Authority inspections
• Perform inspections of third party manufactures and suppliers
• Provide regulatory guidance/input to internal and partnered product review boards
• Participate as a member of the regulatory team that supports a culture of compliance
• Monitors compliance with company policies and procedures (e.g. compliance with FDA, State, etc.).
• Assist in implementing the pharmaceutical regulatory submissions strategy
• Develop submission schedule aligned with product development pipeline to ensure timely submission and approval of applications, amendments, supplements, and other regulatory correspondence
• Manage the compilation and publishing process for routine and regulatory submissions, including oversight of work being performed by contract vendors
• Liaise with country-specific regulatory affairs submission personnel
• Provide information for pharmaceutical product registrations
• Responsible for preparing for global product registration variations and product renewals
• Oversees contract resources

• Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle, including Development, Promotion and Advertising, Labeling, CMC, Commercialization, and Operations.
• Knowledge of domestic and international laws, regulations, and guidance
• Ability to take innovative ideas and design a successful product regulatory strategy and, in so doing, increase probability of regulatory approval
• Ability to support the product development team to assess whether technical arguments are presented
• Knowledge of pharmaceutical industry regulatory affairs discipline throughout the product lifecycle including Development, Commercialization, and Operations
• Knowledge of current and emerging issues and trends of the regulatory environment within specialty area and ability to integrate such within the regulatory affairs organization
• Knowledge of domestic and international regulations relating to the submission and regulatory approval
• Ability to compile and file submissions to Global Regulatory Authorities
• Knowledge of document management and electronic publishing systems (i.e., Documentum, Core Dossier, MS Office applications, Adobe Acrobat, MS Project).
• Strong general technology skills and abilities
• Capability to react quickly to changes in the regulatory environment and make decisions to minimize risk to the business
• Capability to interpret regulatory authority policies and guidance and correctly apply them as appropriate to the submission process
• Regulatory experience with generics
• Able to communicate complex information and analyses to a variety of scientific and non scientific audiences
• Able to mentor less experienced; Clearly assigns responsibility for tasks and decisions, sets clear objectives and measures, monitors process, progress and reSUlts;
• Able to interact with a variety of disciplines to establish policy and optimize processes.
• Doesn't hold back anything that needs to be said; provides current, direct and complete and -actionable- positive and corrective feedback to others; lets people know where they stand; faces up to problems an any person or situation quickly and directly. Is action oriented and not fearful of acting with a minimum of planning.
• Influencing and negotiation skills needed for positive interactions with regulatory agencies and internal and external stakeholders
• Able to build a structured and process-oriented organization, assuring consistent highquality contributions to product and project teams. Provides challenging and stretching tasks and assignments; works with colleagues on to build skills and abilities; is a people builder

• Demonstrated ability in analytical reasoning and critical thinking skills
• Demonstrated ability to lead a multi partner team environment.
• Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
• Excellent communication skills; both oral and written
• Strong interpersonal skills with the ability to influence others in a positive and effective manner
• Demonstrated ability to contribute to a continuous learning and process improvement environment
• Capacity to react quickly and decisively in unexpected situations
• Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
• Focused ability to influence operational excellence and periormance metrics
• Risk adverse where needed with the ability to identify potential solutions to complex problems

• Degree in science and/or business, or equivalent, (with experience in generic industry/drug developmenVcommercialization) with a record of continuous learning and education regarding regulatory processes and policies.
• Prefer 4+ years experience in the generic or pharmaceutical industry.
• International travel and work experience a plus.

• Regulatory experience with filings/approvals for generic drugs
• Proven track record of successful management of staff and complex regulatory issues.
• Proven business management capability and leadership
• Proven track record of credibility with regulators
• Proven ability to think creatively and to develop and execute strategic regulatory filing plan

Benefits

Medical, Dental & Life Insurance available after 60 days of employment.
Medical Flexible Spending Account & Simple IRA Plan available if employees wants to participate.

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