Менеджер по регистрации лекарственных средств

(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:

1. Established connection with regulators and industry professionals for networking opportunities & resolving issues promptly through lobbying, advocacy, negotiation & effective communication
2. Suggests the best alternative to achieve desired outcome, giving consideration to risks, tradeoffs, timing and available resources
3. Identifies regulatory information sources and resources for national and regional regulations
4. Collects and assesses national and regional regulatory intelligence, other related information, monitors the regulatory environment
5. Schedule meetings with regulators or regulatory officials on routine basis
6. Provides information used to evaluate proposed products for regulatory classification
7. Determines requirements and options for regulatory submissions, approval pathways and compliance activities
8. Creates work plans with appropriate staging of activities and with clearly defined milestones
9. Tracks the status of applications under regulatory review and provides updates to the regulatory team at head office
10. Communicates information on regulatory requirements to Head office as soon as received preferably during initial draft stage.
11. Creates clarity and direction amid complexity and develops solutions for the organization
12. Seeks out diverse opinions and insights
13. Participates in development and implementation of new regulatory procedure
14. Able to train stakeholders on current and new regulatory requirements to ensure organization-wide compliance
15. Assists in the development of regulatory strategy and updates strategy based upon regulatory changes
16. Evaluates proposed products for regulatory classification
17. Has understanding of serialization and aggregation requirements
18. Advise on regulatory requirements for quality and clinical data to meet applicable regulations
19. Assesses the acceptability of quality and clinical documentation for submission to comply with applicable regulations
20. Evaluates proposed quality, clinical and manufacturing changes for regulatory filing solutions and proposes plans/strategizes (if appropriate) for changes that do not require submission
21. Provides knowledge and guidance on preapproval inspections, GCP inspections and clinical investigator relationships.
22. Provides regulatory information and guidance for proposed product packaging
23. Ensures that the clinical and nonclinical data—in conjunction with regulatory strategy—are consistent with the regulatory requirements and support the proposed product claims
24. Prepares and submits electronic and paper regulatory submissions according to applicable regulatory requirements and guidelines
25. Monitors the progress of the regulatory authority review process through appropriate communication with the agency.
26. Communicates and interacts with regulatory authorities before and during the review of a regulatory submission through appropriate communication tools
27. Establish interactions with regulatory authorities including panel meetings and advisory committees if needed
28. Develops and implements processes involved with maintaining annual licenses, registrations and listings.
29. Reviews, verifies and approves packaging artworks to ensure regulatory compliance and scientific translation.
30. Keeps abreast with and assesses the scientific and/or clinical advances that impacts health care products and regulation
31. Clearly conveys or exchanges information within and outside the organization in an appropriate and timely manner
32. Prepares for and participates in meetings with internal and external stakeholders
33. Escalates and effectively communicates issues to supervisor and peers and ensures alignment on issues, questions and organization goals
34. Aligns and discusses regulatory issues to ensure completion of project tasks
35. Prepares strategy/briefing documents for panel hearings and informational meetings
36. Frames issues with a thorough understanding of legislation, regulations, guidance, policy and directives.
37. Manages and trains regulatory professionals
38. Assists in the development of regulatory procedures and SOPs
39. Tracks product complaints, events and recalls

Required Knowledge and Skills

1. 9+ years of regulatory experience in pharmaceutical industry
2. Higher education in Pharmacology
3. Can understand and communicate in English language
4. Well aware of health authority structure, decision makers, regulatory and pricing requirements/ policies
5. Have a strong foundation in regulatory process management
6. Have well-developed regulatory technical knowledge, has experience in scientific review of dossier and artwork in Kazakh /Russian Language
7. Can understand and provide pharmacovigilance services
8. Knowledge of regulatory frameworks and external environments and the ability to apply these to regulatory solution
9. Knowledge of requirements and processes for maintaining a product on the market, reporting and surveillance
10. Ability to leverage systems and processes to successfully operate a regulatory function and develop solutions for organization
11. Understanding and application of evolving regulatory science