US Regulatory Affairs Manager

Cipher is a specialty pharmaceutical company with a robust and diversified portfolio of commercial and early to late-stage products. Cipher acquires products that fulfill unmet medical needs, manages the required clinical development and regulatory approval process, and markets those products directly in Canada and indirectly through partners in the U.S., and South America. Cipher operates a lean corporate structure, employs strategic operational partnerships, out and in-licenses products, in addition to making selective investments in drug development to assemble a broad portfolio of prescription products. Position Overview: The Regulatory Affairs Manager plays a crucial role at Cipher Pharmaceuticals Inc. as a lead member of the Regulatory Affairs (RA) and Pharmacovigilance (PV) function, ensuring all activities meet the Federal regulatory requirements for Canada and the United States. This role oversees and coordinates Third-Party support to ensure pre-defined deliverables are achieved. The successful candidate will be a key participant in regulatory strategy and will be responsible for day-to-day activities for assessing and providing post-market change controls, preparation of required Regulatory documents/dossiers such as regulatory submissions, Annual Drug Notification forms and PSURs, Annual Reports and PADERs for the United States market. This candidate will also manage regulatory/pharmacovigilance SOPs and ensure all functional operations are in accordance with Federal regulations. In addition, the successful candidate will be interacting with regulatory authorities and cross-functional teams for coordinating project-related activities, in particular Quality Assurance, while ensuring the continuing enhancement of the Company`s ethical image. Duties and Responsibilities: Manages the Cipher Regulatory files, ensuring the development of operating procedures and standards in alignment with current local and regional regulatory requirements (FDA and Health Canada). Directs regulatory support for the development and registration of products to the FDA and Health Canada, such as NDS/SNDS/NDA/ANDA and DMF submissions, amendments, supplements, and annual reports. Provides support for Market Access drug listings. Provides support for drug product Import/Export Licenses for manufacturing sites. Oversees FDA submissions including product-specific import/export licenses as applicable. Supports the Cipher change control system and provides Regulatory Impact Analyses for each proposed Change Control. Provides support for pharmacovigilance-related activities ensuring adverse events are identified and processed in accordance with international regulations by working with senior team members. Provides oversight and support for external safety data processing provider ensuring high quality and compliant individual case safety report processing. Ensures global pharmacovigilance activities are compliant with all applicable regulations. Coordinates audit preparation and regulatory Pharmacovigilance inspections and audit responses. Develops departmental SOPs and coordinate training as required. Participates in the development and implementation of methods, procedures, and regulations necessary for the smooth operation of the business. Works in a cooperative manner with managers, supervisors, coworkers, customers, and Third-Party providers. Provides expertise and guidance as required to manufacturing partners in interpreting applicable governmental regulations, agency guidelines, and procedures to ensure compliance. Drives accountability and continuous improvement through training, SOPs, and workflows as needed to proactively improve quality, efficiency, and standardization of RA/PV activities. Manages and updates Third-Party Service and Technical agreements as required. Other related work as assigned. Qualifications: BSc/MS in Pharmaceutical Sciences, Pharmacy, Chemistry, or Related Fields. +10 years of Regulatory experience in New Drug development and registration including a minimum of 10 years of Regulatory Affairs or pharmacovigilance experience. Exposure and/or experience with Health Canada Drug Master File (DMF) is an asset but not a requirement. Extensive experience with Post Approval of Product Changes. Experienced in filing Patent Form IVs. Experienced in or have managed PV data collection, and preparation of report summaries for submission to Health Canada/FDA. Experience with a PV audit. Regulatory Affairs Certification (RAC) is a plus. Excellent interpersonal written and oral communication skills Proficient in Microsoft Office including advanced skills in Excel (Pivot tables, V-lookup, Macros, Formulas). Ability to coordinate, contribute to and work within a cross-functional team. Ability to assess the regulatory impact of changes via the change control process. Experience with global pharmacovigilance systems is an asset. Overall knowledge of pharmaceutical development, manufacturing and packaging, registration, and market access approval processes. Sound problem-solving and negotiation skills. Job Type: Full-time Pay: From $85,000.00 per year Education: Bachelor's (Required) Experience: FDA regulations: 5 years (Required) License/Certification: Regulatory Affairs Certificate (RAC) (Preferred) Ability to Commute: Carmel, IN 46032 (Required) Work Location: In person