Associate Regulatory Affairs Manager

VIATRIS VIETNAM
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Mô tả công việc

Mainly responsible for regulatory affairs support related to new and in-line products within the country. The activities encompass regulatory submissions to the authorities for registration of new products, variations to marketed products, and miscellaneous application such as ad-hoc requests and permits, special exemption when required, and general product maintenance.
The Regulatory Affairs Associate Manager is expected to support expediting product commercialization by ensuring that local registration requirements are fulfilled and registration approvals are obtained in the shortest possible time.
Regulatory support:
Support the Head of Regulatory Affairs (HRA) 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.
- Maintains awareness of changes to laws, regulations and requirements and keeps the other department managers informed of these changes as soon as possible.
- Support Labeling and Artwork change management activities for products in responsible portfolio to ensure compliance to information and implementation timelines.
- Work in close collaboration with other stakeholders within the organization to ensure efficient and consistent execution of strategic regulatory plans across Viatris portfolio.
- Support resolution of production and manufacturing issues, such as submission/negotiation strategy, sourcing issues, packaging issues, and compliance matters.
- Support activities related to product license maintenance and resolution of relevant regulatory issues.
- 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.
- Support the maintenance of the relevant record and Viatris Systems while ensuring timely updates as governed by the SOP.
- Provide document review in order to ensure the regulatory quality and scientific integrity of documents submitted to regulatory authorities and publications.
- Review, analyse, coordinate and provide feedback to HRA in matters relating to new product submissions and post approval maintenance of products as required.
Communication
- Monitor, analyse, interpret and inform HRA regarding regulatory trends and events including matters such as regulatory guidelines, regulatory environment issues, regulation and external meetings concerning regulatory matters.
- Keep abreast of the external regulatory environment, including competitor intelligence, local product and international regulatory and commercial strategies.
- Ensure effective communication and collaboration with internal & external stakeholders and other functions
- Support HRA to anticipate changes in country registration policies and guidelines and keeps relevant Viatris groups informed of changes in the regulatory environment.
- Monitor and consult HRA for dissemination of information on changes to regulations affecting registration, manufacture, distribution and sale of Viatris products
- Interact and participate in negotiation discussions on regulatory matters concerning Viatris’s portfolio/interest and also involve in relationship building with Regulatory Authorities and Industry Associations, as appropriate.
Shaping the external regulatory environment
- Understand local regulations and developing trends in the local regulatory environment and provide assessment of the impact to key stakeholders. Leverage regulatory intelligence / landscape knowledge to support the development and implementation of regulatory and business strategies and decision making.
- Support HRA to maintain and enhance partnership with regulatory affairs-related organization and relevant industry associations to share information/knowledge and help shape a better health care environment.
Inventory support
Support HRA in coordinating with Supply Chain (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
- Provide regulatory input to HRA to support marketing plans, product launches and other cross-functional activities.
- Support review of promotional materials that are in keeping with Viatris’s standards by providing latest labelling information and strategizing product labelling to Viatris’s benefit.
Support for vendor management
- Provide 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
- Manage vendors to deliver submission and approval timeline inline with business priorities and in compliance with company policy/requirement
Regulatory Compliance
- Coordinate with HRA on product recall activities with sales, marketing, logistic and distributor which may be required by manufacturer or Regulatory Authority.
- 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 Viatris SOPs.
- Support HRA to ensure registered products are maintained in full compliance with all relevant legislation and SOP procedures.
Support for team management
- Support HRA to develop and review SOP’s, systems and processes within the regulatory affairs function.
- Support HRA in document review and training to team members.
- Support HRA to establish a good team culture and working environment

Yêu cầu công việc

- Bachelor degree of Pharmacy, graduated from Ha Noi University of Pharmacy (prefer major in Pharmaceutical Industry/ Clinical Pharmacy)
- Proven ability to consistently deliver to time, cost and quality standards
- Ability to effectively deliver in a complex matrix environment
- Good knowledge of international and local regulatory guidelines
- 7+ years of experience in RA function in multi-national Pharmaceutical companies
- Fluent in English – written and spoken communication skill
- Meticulous nature and proficient in data tracking and consolidation

Quyền lợi

13th month salary, Performance Bonus

Annual leave

Cập nhật gần nhất lúc: 2021-12-22 17:22:02

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VIATRIS VIETNAM

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Ngành nghề
Dược Phẩm/Công nghệ sinh học, Dược sĩ
Cấp bậc
Nhân Viên
Kinh nghiệm yêu cầu
Đang cập nhật
Trình độ yêu cầu
Đang cập nhật
Số lượng cần tuyển
Đang Cập Nhật
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Giới tính
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Hạn nộp hồ sơ
22/12/2021
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