Senior Regulator Affairs Associate

Responsibilities
* Support the Regulatory Affairs Head to develop registration strategies, prioritize
assignments, implement regulatory plans, adhere to local regulatory guidelines and
requirements and coordinate multiple projects and activities in accordance with company’s
strategic objectives.
* Support expediting product commercialization by ensuring that country’s registration
requirements are fulfilled and registration approvals are obtained as quickly as possible.
* Review, analyses, coordinate and provide feedback to Regulatory Affairs Head
in matters relating to new product submissions and post approval maintenance of products as
required.
* Work in close collaboration with other stakeholders within the organization to ensure
efficient and consistent execution of strategic regulatory plans across Company’s portfolio.
* Support Labeling and Artwork change management activities for products in responsible
portfolio to ensure compliance to information and implementation timelines.
* Review and approve consumer medicine information, packaging labels, promotional material
and other documentation as required for regulatory compliance, when required (if
applicable).
* Provide document review in order to ensure the regulatory quality and scientific integrity of
documents submitted to regulatory authorities and publications e.g. MIMS update.
* 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 Company 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 administrative and strategic support for Poison License and Clinical trial
maintenance activities (where applicable).
Communication
* Ensure effective communication and collaboration with stakeholders and other function leads (e.g. GCMC, RegOps, PGS, Commercial, Medical etc.).
* Interact and participate in negotiation discussions on regulatory matters concerning Company’s portfolio/interest and also involve in relationship building with Regulatory Authorities and Industry Associations, as appropriate.
* Monitor, analyse, interpret and inform Regulatory Affairs Head regarding regulatory trends and events including matters such as regulatory guidelines, regulatory environment/climate issues, regulation and external meetings concerning regulatory matters.
* Support Regulatory Affairs Head to anticipate changes in country registration policies and guidelines and keeps relevant Company groups informed of changes in the regulatory environment.
* Keep abreast of the external regulatory environment, including competitor intelligence, local product and international regulatory and commercial strategies. * Monitor and consult Regulatory Affairs Head for dissemination of information on changes to regulations affecting registration, manufacture, distribution and sale of Company products.
Environmental Shaping
* Monitors, analyzes, interprets and informs Regulatory Affairs Head regarding regulatory trends and events including changes in matters such as regulatory guidelines, regulatory environment/climate issues, regulations, competitor intelligence and external meetings concerning regulatory matters.
* Support Regulatory Affairs Head to anticipate changes in country registration policies and guidelines and keeps relevant Company groups informed of changes in the regulatory environment.
Management
* Support the overall strategic direction, staffing, budget input for the Regulatory Affairs Head and training of the Regulatory Affairs Group, in accordance with the Company SOPs and Core Values.
* Participate in the relevant Regulatory Affairs meetings and support Regulatory Affairs Head in encouraging interdepartmental communication.
* Develop systems and process improvements to continuously improve support for Company in the market place.
* Participate in and promote team building and provide a stimulating environment which encourages team and individual growth.
* Effectively plan and monitor self-performance to meet set objectives.
* Own self-development, performance management and career planning.
Inventory Support
* Support Regulatory Affairs Head in coordinating with PGS (and other relevant stakeholders), to ensure stock availability to local market, while strategically planning the timing to ensure stocks availability for new product launches.
Marketing Support
* Support the development/review of promotional materials that are in keeping with Company’s standards by providing latest labelling information and strategizing product labelling to Company’s benefit.
* Provide regulatory input to Regulatory Affairs Head to support marketing plans, product launches and other cross-functional activities.
Regulatory Compliance
* Be accountable for regulatory compliance (of records and systems) within the area of responsibilities.
* Complete relevant training activities and comply with relevant standards in the local office to ensure compliance to local, international regulations and Company SOPs.
* Support Regulatory Affairs Head to ensure registered products are maintained in full compliance with all relevant legislation and SOP procedures.
* Coordinate with Regulatory Affairs Head on product recall activities with sales, marketing, logistic and distributor which may be required by manufacturer or Regulatory Authority.

Qualifications
* Bachelor’s degree in Science or Pharmacy
* Preferably 3 year of working experience in a regulatory affairs environment
* Fluent in English – written and spoken communication skills
* Good knowledge of international or local regulatory guidelines and codes
* Preferably with knowledge across multiple therapeutic areas
* Meticulous nature and proficient in data tracking and consolidation
* Proven ability to consistently deliver to time, cost and quality standards.
* Ability to effectively deliver in a complex matrix environment

- Attractive bonus scheme
- Healthcare Insurance for employee and family
- 18 annual leave days and 9 sick leave days

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