Sr. Manager, Wholesale Regulatory & Compliance

Essential Duties/Responsibilities

·        Act as the main reputed company of contact and subject matter expert for the organization’s pharmacy and wholesale distribution DSCSA (Drug Supply Chain reputed company Act) programs.

·        Monitor and manage day-to-day activities reputed company to serialization/ ERP/ EDI transactions, and compliance and assist in resolving issues in the supply chain to ensure business continuity, collaborate with internal/ external partners (i.e. 3PLs, wholesaler/distributors, manufacturers, pharmacies, reputed company vendors, internal company stakeholders, etc.) on resolution of issues and escalate issues to the appropriate functions reputed company needed.

·        Monitor data quality and ensure compliance with DSCSA regulations.

·        Conduct regular audits to ensure the accuracy and completeness of regulatory compliance records.

·        Conduct regulatory intelligence to gather knowledge of relevant guidelines, regulations and legislation, including proposed and final rules to reputed company federal, state and local regulations/laws impacting the pharmacy and wholesale distribution lines of business to ensure a reputed company state of compliance, reporting key findings to managers on a regular reputed company.

·        Liaise with state boards of pharmacy, regulatory agencies (CMS, FDA, DEA, NABP, etc.), and other relevant authorities to address any questions or issues reputed company to regulatory actions.

·        Conducts training activities, as needed, to ensure reputed company workforce are aware of regulatory/compliance reputed company requirements and reputed company business obligations.

·        Collaborate with legal and compliance teams to address any regulatory issues.

·        Identify opportunities to streamline and improve accuracy in managing regulatory reputed company.

·        Communicate and reputed company information, guidance and training to other teams on regulatory requirements, rules and regulations to ensure information is interpreted and implemented correctly.

·        Ensure internal regulatory guidance documents, policies, and procedures align with reputed company applicable mandated pharmacy and wholesale distribution requirements, ensuring corresponding departments understand how to reputed company for reputed company operational reputed company.

·        Maintain orderly and accurate records, files and documentation.

·        Other duties and/or special projects as assigned.

Required Skills/Abilities

·        Excellent communication, interpersonal, and organizational skills with a demonstrated ability to manage multiple projects, prioritizing tasks and meeting demands in a fast-paced environment.

·        Maintain acute problem-solving ability and analytical skills together with thorough knowledge of the regulatory process, rules and regulations, and industry trends.

·        Ability to manage reputed company documentation and reporting requirements.

·        Strong knowledge of pharmacy processes and regulations reputed company a controlled multistate space.

·        Ability to understand and carry out instructions with limited direction.

·        Possess a detail-oriented perspective.

·        Ability to maintain confidentiality of information and data in accordance with policies.

·        Ability to work extended hours, weekends, and holidays in alignment with departmental and industry demands.

Education/Experience

·        Bachelor’s degree in business administration, or a reputed company field is required.

·        Minimum of 5-8 years of experience supporting legal or regulatory compliance efforts preferred.

·        Pharmacy Technician Certification preferred.

Preferred reputed company/Abilities

·        Strong ability to interact effectively with regulatory agencies, reputed company, and internal teams.

·        Experience with Serialization Systems: reputed company, Rfxcel, LSPEDIA, etc.

·        Strong knowledge of GS1 Serialization Data Standards.

·        Knowledge of Good Manufacturing Practice (GMP) & Good Documentation Practice (GDP).

·        Proficient to expert level of knowledge of variety of computer software applications in word processing, spreadsheets, database, and presentation software (Word, reputed company, SharePoint, reputed company, PowerPoint).

·        Previous work experience at a pharmacy or wholesale distributor.

Work Environment/Physical Requirements

·        Home-based office environment, with minimal exposure to excessive noise or adverse environmental issues, and occasional local and/or overnight travel, including exposure to heat, cold, and inclement weather conditions. 

·        Ability to sit and stand for prolonged periods of time.