• Regulatory Lead Jobs in Indonesia

  • Pfizer Inc.
  • Indonesia

Job Description:

Regulatory Support

Develop registration strategies, prioritize assignments, implement regulatory plans, adhere to local regulatory guidelines and requirements and coordinate multiple projects and activities in accordance with companys strategic objectives
Expedite product commercialization by ensuring that countrys registration requirements are fulfilled and registration approvals are obtained as quickly as possible
Review, analyze and co-ordinate new product submissions, line extensions, variations to marketed products, any other product maintenance activities and responses to Regulatory Agencies
Set-up and attend pre-submission and appeal meetings where appropriate
Work in close collaboration with other stakeholders within the organization to ensure efficient and consistent execution of strategic regulatory plans across Pfizers portfolio and be accountable for regulatory compliance within the area of responsibilities
Review and approve draft Labeling & Artwork, negotiation of first approval labeling with Regulatory Authorities, and labeling revisions over the course of the products life cycle This also includes the ensuring that Local Product Documents are consistent with appropriate Pfizer reference documents
Review and approve patient information leaflet, packaging labels, promotional materials and other
documentation as required for regulatory compliance, where applicable
Supervise document review in order to ensure the regulatory quality and scientific integrity of documents submitted to Regulatory Authorities and publications eg MIMS update
Monitor monthly report of activities and communicate updates to relevant stakeholders
Takes accountability in overseeing the maintenance of the relevant regulatory processes and systems to ensure compliance and timely updates
Plan and execute process improvement initiatives
Support activities related to product licence maintenance and resolution of relevant regulatory issues
Support resolution of production and manufacturing issues, such as submission/negotiation strategy, sourcing issues, packaging issues, and compliance matters
Maintains awareness of changes to laws, regulations and requirements and keeps the other department managers informed of these changes as soon as possible
Support the maintenance of the relevant record and Pfizer Systems while ensuring timely updates as governed by the SOP
Provides oversight and monthly report of activities associated with the approval of a product including such activities as development and coordination of responses to Regulatory Authority inquiries, monitoring and informing with respect to product filings, approvals and launches and track performance against agreed timelines and budget
Provide regulatory consultation for marketing plans, product launches and other cross-functional activities
Analyze and participate in the development of promotional materials that are in keeping with Pfizers standards by providing latest labeling information and strategizing product labeling to Pfizers benefit
Provide updates on competitor intelligence and registration updates in a timely manner

Communication

Ensures effective communication and collaboration with stakeholders, other Function Leads (eg GCMC, RegOps, PGS, Commercial, Medical etc) and external stakeholders on matters of mutual interest
Disseminate of relevant information on products and products changes including safety and quality changes (where applicable) to internal and external stakeholders as appropriate
Monitor the dissemination of information on changes to regulations affecting registration, manufacture, distribution and sale of Pfizer products
Interacts and participates in negotiation discussions on regulatory matters concerning Pfizers portfolio with Regulatory Authorities, as appropriate
Maintain and strengthen communication with appropriate offices of the Regulatory Agencies and professional bodies (IPMG etc)
Represent company at government and industry association meetings to achieve agreement of strategic importance and environment shaping
Liaise and negotiate with the relevant Agencies to facilitate and secure expeditious regulatory approvals
Initiate regular communication and meetings with regulators to enhance relationships
Interact and work with management / employees to promote teamwork
Regularly communicate updates to the Regulatory Affairs Team
Monitors, analyzes, interprets and informs regarding regulatory trends and events including matters such as regulatory guidelines, regulatory environment/climate issues, regulations and external meetings concerning regulatory matters
Monitor changes in country registration policies and guidelines and keeps relevant Pfizer groups informed of changes in the regulatory environment

Management

Provide direction on system development and process improvements to continuously improve support for Pfizer in the market place
Promote team building and provide a stimulating environment which encourages team and individual growth
Conduct one-on-one session with Regulatory Team
Provide coaching on Regulatory Teams IDP development
Develop IDP
Effectively plan and monitor self-performance to meet set objectives
Own self-development, performance management and career planning

Regulatory Compliance

Ensure for regulatory compliance (of records and systems) within the area of responsibilities
Ensure the completion of relevant training activities and comply with relevant standards in the local office to ensure compliance to local, international regulations and Pfizer SOPs
Ensure registered products are maintained in full compliance with all relevant legislation and SOP procedures
Provide direction on product recall activities with sales, marketing, and logistic which may be required by manufacturer or Regulatory Authority
Review and update Country Business Continuity Plan (BCP) annually

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates

Profile Summary:

Employment Type : Full Time
Eligibility : Any Graduate
Industry : Biotechnology/Pharmaceutical/Medicine, Manufacturing/Industrial
Functional Area : Production/Manufacturing/Maintenance/Packaging
Role : Production/Manufacturi ng/Maintenance
Salary : As per Industry Standards
Deadline : 18th Mar 2020

Key Skills:

Company Profile:

Company
Pfizer Incarfix

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