Decides on local regulatory strategic and operational matters to fulfil the local business strategies, in coordination with the local functions and with close coordination with Regional Heads and other Global regulatory units. Ensures transparent, timely and efficient communication with business, supply chain and other local functions, providing regulatory expertise to achieve common decisions. Effectively manages priorities across divisions.
Managerial responsibility of the regulatory affairs staff in the country, including talent management and people development, succession planning. Responsible for the preparation of local budgets and the adequate hiring and training of staff. Identifies resource requirements and allocates resources to meet regulatory needs. Ensures early identification of conflicts between projects and ensures transparent and aligned prioritisation.
Ensures the preparation of the application files for products based on the documentation provided from GRA Regulatory Partners in accordance with local regulations, of acceptable standard and quality to present them to the respective authorities.
Ensures the preparation of the application files for clinical trials, based on the documentation provided from GRA Regulatory Partners, are in accordance with the local regulations and presents them to the respective authorities, where locally relevant
Supports the LQR to plan, manage GMP inspection requirements incl. GMP applications, inspections and certifications of the manufacturing sites as locally relevant. Work closely with LQR to manage product complaints and recall process, including health authority interaction and communications. Provide necessary documents to enable LQR to complete local compliance checks
Regulatory quality management: Responsible for local and internal compliance to regulatory affairs relevant processes and systems, creation and maintenance of a local quality system including archiving, contact reporting, maintenance of regulatory tracking database and tracking of documents submitted. Manages training and audits of the quality system.
Ensures regulatory compliance for a sustainable life-cycle management: Labelling and CMC changes are performed in accordance with local regulations and relevant The company SOPs
Responsible to represent the company as a competent reliable partner to the local Health Authorities in all regulatory matters, to enable timely approvals with optimal labels. Proactively shapes the regulatory environment in the country. Ensures appropriate representation of BHC in the local industry associations. Builds strong regulatory networking with national regulators, local industry organisations and key opinion leaders. Oversees communication with Health Authority to ensure The company one voice policy.
Provides local RA intelligence: Identifies current and emerging national regulations which impact the drug development and / or marketing processes and ensures appropriate contribution and communication with all involved areas. Contributes actively to design and assessment of RA strategic options as a member of regional regulatory teams
Master’s Degree in Life Sciences or equivalent scientific degree with a minimum of 7-10 years pharmaceutical industry experience in regulatory affairs with at least 2 years of proven experience in health authority interactions and negotiations, in managing projects and resources and demonstrated track record of providing workable solutions to complex regulatory problems
Fluent in English ability to communicate effectively both orally and in writing, with proven persuasive, assertive and negotiating skills. Convincing presentation skills are required. Demonstrated cross-functional communication skills.
Ability to focus on multiple issues at one time, ability to organize, prioritize and direct diverse activities in a changing environment often under time pressure.
Strong managerial and leadership skills to lead and motivate cross functional teams and direct reports, in line with our company LIFE values. Strong team building abilities.
Solid and demonstrated knowledge of all compliance aspects related to the regulatory affairs function.
Thorough knowledge of company policies and procedures. Detailed understanding of the operating procedures and policies of the national or agency or deep experience with a related national health authority.
Ability to develop effective solutions to diverse and complex business problems
Ability to clearly voice The company’s and Global Regulatory Affairs needs, high degree of accuracy and reliability.
Exposure to wide range of business activities and projects, including in-licensing and out-licensing projects, desirable
Profound knowledge of local regulations in Thailand and its requirements, overview knowledge of regulations in US, EU or other APAC region countries helpful. Knowledge of local regulations in Cambodia, Laos, Myanmar highly desired
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*All applications will be treated in strict confidentiality. All material submitted in connection with your application will become part of our confidential recruitment files. We regret that only shortlisted candidates will be notified.