Regulatory Affairs

Position: Senior Specialist, Regulatory Affairs (Vietnam)

Reports to: Director, Regulatory Affairs, Asia

Location: Hanoi, Vietnam

Working time: 9:00 – 6:00; Mon - Fri

Salary: Negotiable

1. JOB SUMMARY

Develop regulatory strategies, submissions and approvals with Company’s distributors for new product (pharmaceutical and medical device) registrations and life-cycle management of registered products and ensure regulatory compliance is maintained for company (Pharma and Aesthetics).
Support business and cross functional teams from regulatory perspective.
Ensure adherence to Company’s SOPs and compliance with regulations.
Monitor emerging trends regarding industry regulations.
Other regulatory projects and tasks assigned by Regulatory Affairs (RA).

2. CORE JOB RESPONSIBILITIES

Product Registration and maintenance:

Manage regulatory projects and activities in accordance with strategic company objectives.
Primary contact with distributors.
Vietnam distributors is responsible as MAH to liaise with Regulatory Authority in Vietnam for responsible products; where required/requested by company, the candidate will facilitate communication with Vietnam regulatory authority for regulatory matters.
Work with distributors to develop registration strategies, to plan and execute regulatory submissions for new products, new indications, visa extensions, renewals, change controls and any other required changes to maintain current registration of all products, in alignment with planned timelines, to deliver timely approval with desired labeling.
Assess and interpret the regulatory strategies and timelines developed or suggested by distributors, with suitable proposals where required.
Facilitate communication between company area Regulatory lead and distributors in Vietnam.
Active participation/contribution in Abbive Area Regulatory meetings pertaining to products update and strategy.
Work with Area Regulatory Lead on the proposed registration strategies, dossier preparation, response to questions, and other regulatory matters, in alignment with the planned timelines.
Provide regular registration status to company RA.
Assess developments in Vietnam regulations and evaluate impact to products and business and communicate to RA in a timely manner.

Business Support:

Develop registration strategies to support business case assessment.
Work cross-functionally as required to meet business needs.
Facilitate communication with company brand team for Vietnam regulatory matters.
Participate in business meetings, where applicable
Provide regulatory input and support to cross functional activities including tender, marketing plans, promotional materials, as required, from a regulatory perspective.
Provide regulatory updates on registration status during brand team and other business meetings.

Processes:

Responsible for requests of documents via systems.
Responsible for artwork and label management.
Maintain global company systems and databases to ensure that all relevant regulatory information is updated.
Ensure proper filing and maintenance of local documentation as per corporate procedures.
Participate in projects to streamline RA processes to increase productivity, where applicable.

Compliance:

Maintain good knowledge of relevant regulatory corporate policies and ensure compliance.
Ensure adherence to SOPs and compliance with regulations.

Regulatory Intelligence:

Keep up to date for product registration, variation, line extension and other related law & regulations knowledge.
Keep abreast of changes in the regulatory environment to assure accuracy and effectiveness in regulatory submissions.
Monitor changes related to the Regulatory Authority on law & regulations affecting registration, manufacture, distribution, and sale & marketing of the products.
Maintain an awareness of country’s regulatory legislation and assess its impact on business.
Assess the interpretation of the Vietnam regulations by distributors, with suitable proposals.
Work with distributors to ensure that the Regulatory Requirement Database is kept up to date.
Ensure RA is kept informed in a timely manner of all regulatory intelligence.
Communicate issues, due to new or changes to regulations and their impact, to RA without delay.

3. PREFERRED QUALIFICATIONS

University degree in Pharmacy or Pharmaceutical Science, or related disciplines
Minimum 5 years of regulatory experience in the pharmaceutical and/or medical device industry.
Fluent Vietnamese and good command of English.
Knowledge of Vietnam regulations in pharmaceutical and medical device.
Understands business needs and impact of regulatory issues.
Strong interpersonal skills. Ability to function as an effective team member.
Ability to work independently and proactively.
Active participation/contribution in Abbive Area Regulatory meetings pertaining to products update and strategy.’

4. BENEFITS

APPLICATION: Interested candidates please send your updated CV to email: hieu.cao@manpower.com.vn Phone/Zalo: Ms. Hieu – 08 68 854 317.