Менеджер по регистрации лекарственных средств и фармаконадзору

(Опыт регистрации ЛС на фармацевтическом рынке Казахстана и знания английского языка обязательны)

Job Title:

Manager Regulatory Management

Reports to:

Head of Regulatory Management – Global

Position Summary and Purpose:

To address regulatory and government affairs challenges, will oversee all regulatory matters related to product registrations, renewals, post-approval variation and post approval surveillances, pharmacovigilance, Site inspection etc, ensure timely compliance and smooth business operations by management of regulatory or government related issues.

Key Responsibilities:

Established connection with regulators and industry professionals for networking opportunities & resolving issues promptly through lobbying, advocacy, negotiation & effective communication

Suggests the best alternative to achieve desired outcome, giving consideration to risks, tradeoffs, timing and available resources

Identifies regulatory information sources and resources for national and regional regulations

Collects and assesses national and regional regulatory intelligence, other related information, monitors the regulatory environment

Schedule meetings with regulators or regulatory officials on routine basis

Provides information used to evaluate proposed products for regulatory classification

Determines requirements and options for regulatory submissions, approval pathways and compliance activities

Creates work plans with appropriate staging of activities and with clearly defined milestones

Tracks the status of applications under regulatory review and provides updates to the regulatory team at head office

Communicates information on regulatory requirements to Head office as soon as received preferably during initial draft stage.

Creates clarity and direction amid complexity and develops solutions for the organization

Seeks out diverse opinions and insights

Participates in development and implementation of new regulatory procedure

Able to train stakeholders on current and new regulatory requirements to ensure organization-wide compliance

Assists in the development of regulatory strategy and updates strategy based upon regulatory changes

Evaluates proposed products for regulatory classification

Has understanding of serialization and aggregation requirements

Advise on regulatory requirements for quality and clinical data to meet applicable regulations

Assesses the acceptability of quality and clinical documentation for submission to comply with applicable regulations

Evaluates proposed quality, clinical and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submission

Provides knowledge and guidance on preapproval inspections, GCP inspections and clinical investigator relationships.

Provides regulatory information and guidance for proposed product packaging

Ensures that the clinical and nonclinical data—in conjunction with regulatory strategy—are consistent with the regulatory requirements and support the proposed product claims

Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines

Monitors the progress of the regulatory authority review process through appropriate communication with the agency.

Communicates and interacts with regulatory authorities before and during the review of a regulatory submission through appropriate communication tools

Establish interactions with regulatory authorities including panel meetings and advisory committees if needed

Develops and implements processes involved with maintaining annual licenses, registrations and listings.

Reviews, verifies and approves packaging artworks to ensure regulatory compliance and scientific translation.

Keeps abreast with and assesses the scientific and/or clinical advances that impacts health care products and regulation

Clearly conveys or exchanges information within and outside the organization in an appropriate and timely manner

Prepares for and participates in meetings with internal and external stakeholders

Escalates and effectively communicates issues to supervisor and peers and ensures alignment on issues, questions and organization goals

Aligns and discusses regulatory issues to ensure completion of project tasks

Prepares strategy/briefing documents for panel hearings and informational meetings

Frames issues with a thorough understanding of legislation, regulations, guidance, policy and directives.

Manages and trains regulatory professionals

Assists in the development of regulatory procedures and SOPs

Tracks product complaints, events and recalls

Required Knowledge and Skills

9+ years of regulatory experience in pharmaceutical industry

Higher education in Pharmacology

Can understand and communicate in English language

Well aware of health authority structure, decision makers, regulatory and pricing requirements/ policies

Have a strong foundation in regulatory process management

Have well-developed regulatory technical knowledge, has experience in scientific review of dossier and artwork in Kazakh /Russian Language

Can understand and provide pharmacovigilance services

Knowledge of regulatory frameworks and external environments and the ability to apply these to regulatory solution

Knowledge of requirements and processes for maintaining a product on the market, reporting and surveillance

Ability to leverage systems and processes to successfully operate a regulatory function and develop solutions for organization

Understanding and application of evolving regulatory science