Regulatory Affairs Director

cap NA Topjobs' client

location Ho Chi Minh City / Ha Noi

post time Posted 79 months ago

Position Title: Regulatory Affairs Director

Reporting Responsibility

Managing Director and Regional Regulatory Rx

Business Department: Rx

Key Dimensions

· Drive regulatory strategy for diversified business- ensure that all new products are registered within the time frame so that they can be launched as per launch excellence plans and maintain life cycle management and compliance with registered information.

· Develop regulatory intelligence capabilities to identify real time changes in the regulatory landscape & influence guidelines/policies.

· Protect and enhance quality and reputation of the company with the regulatory authority by ensuring highest standard of regulatory practice in the LOC and licenses are in compliance with registered details.

· Maximize business efficiencies via ADP and embed continuous improvement and KPIs into ways of working

· Ensure compliance with local, regional and global regulatory SOP’s and processes.

Job Purpose

The Director of Regulatory Affairs is responsible for defining and implementing regulatory strategies to obtain global approvals of the company products in order to support meeting business objectives. The Director of Regulatory Affairs must also ensure compliance with global regulations for licenses, safety reporting, complaints, clinical trial requirements, post approval commitments, labeling, and risk management. Director of Regulatory Affairs provides the Regulatory Affairs department interface to executive management and assume responsibilities as Company Pharmacist.

Key Responsibilities

Lead, manage and motivate regulatory affairs team to :-

· Implement and drive the department’s objectives and plans to support company’s business goals.

· Provide regulatory support and assessment of new product introductions under commercial plans, and develop and manage product registration strategies in line with business priorities and maximizing the competitive advantages of company assets from development, to launch, and throughout product lifecycle.

· Collaborate with cross-functional teams (including Commercial, Medical, Government Affairs, CS&L etc) to achieve local business targets and to ensure regulatory strategies and processes are in line with local business objectives.

· Represent the department in cross-functional meetings, i.e., RMCB, MGC, LIC, PIRC, CRM etc.

· Interface with Area /Central Regulatory to develop filing strategy and communicate on current dossier requirements for timely registration submissions.

· Liaise with local regulatory authorities and Area/Central Regulatory to deliver timely and commercially advantageous product licence approvals.

· Build strong and effective working relationships with the regulators and industry associations and act as the lead contact point between the regulatory agency and the company.

· Manage and co-ordinate product artwork activities to ensure compliance with local registered details.

· Ensure that products circulating in the market are covered with valid and up-to-date registrations and all regulatory post approval commitments are complied with.

· Ensure that Regulatory databases (including OPAL, REQUIRE, local RA trackers) are up to date with accurate information consistent with the source document

· Ensure compliance with local, regional and global regulatory SOP’s and processes by conducting regular management monitoring checks.

· Ensure that the RA staffs are adequately trained to fulfil the roles identified.

· Manage communication of major alerts to local authorities with appropriate follow-up as directed by Corporate (with assessment of local risk and regulatory impact and development of issues management plan).

· Monitor the regulatory environment and communicate updates to relevant functions.

· Attentive to local and international safety alerts that may have local regulatory impact and formulate action if needed.

· Maximize business effectiveness via ADP and embed continuous improvement and KPIs into ways of working

· Shape the regulatory environment and influence regulations to ensure positive outcomes for the company and industry by participating and contributing through regulatory subcommittee of local industry associations on the local front; and APRIA & ASEAN PPWG on the regional harmonization level.

· Identify and escalate risks.

People Management:

Mâ Manage team and develop skills and abilities of regulatory team members with coaching and sharing best practices and key learnings. Conduct regular team meetings for active engagement with regulatory team members to cascade key updates, share learning and provide advice on regulatory matters.

Job Factors

Knowledge

Technically proficient in the area of product registration. Ethical and scrupulous. Discreet, trustworthy and reliable in dealing with confidential information.

Complexity

Detail oriented, pro-active and tactfully assertive. Good communication skills.

Specialised Knowledge

Qualification

· Registered pharmacist possessing a degree in Pharmacy or related science back ground

Experiences

· Tertiary qualifications – pharmacy degree

· Minimum of 10 years’ regulatory experience in pharmaceuticals MNC.

· Good knowledge on current regulatory requirements.

Competencies Required

· Professional written and verbal communication skills

· Team work and people management skills