Director of Regulatory Affairs

Director of Regulatory Affairs

GlaxoSmithKline Pte Ltd
10-13 years
Not Specified

Job Description


Job Description :

Site Name: Vietnam - Hanoi Posted Date: Feb 15 2022 Would you like to drive change and transformation efforts that enable successful regulatory outcomes for GSK If so, this Director of Regulatory Affairs role could be an ideal opportunity to explore. As the Director of Regulatory Affairs is responsible for defining and implementing regulatory strategies to obtain global approvals of GSK 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 for Regulatory Affairs provides the Regulatory Affairs department interface to executive management and assume responsibilities as Company Pharmacist This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following 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 the line with business priorities and maximizing the competitive advantages of company assets from development, to launch, and throughout the 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, MMM, CRM etc. Interface with regional regulatory to develop filing strategy and communicate on current dossier requirements for timely registration submissions. Liaise with local regulatory authorities and regional regulatory to deliver timely and commercially advantageous product license 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 GSK. 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 issus 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. Manage country prescribing information and product labelling to ensure maximum competitive advantage, and compliance to company labelling policy and local regulatory requirements. 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 GSK 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: Lead, manage and coach the Regulatory team through development of skills and capabilities of team members. Conduct Regulatory team meetings for active engagement with regulatory team members to cascade key updates, share learning and provide advice on regulatory matters Why you Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Qualification: registered pharmacist possessing a degree in Pharmacy or related science background. Experience: Tertiary qualifications - medical/pharma degree Minimum of 10 years regulatory experience in pharmaceuticals MNC Good knowledge on current regulatory requirements. Competencies required: Professional written and verbal communication skill Teamwork and people management skill Good time management skill, with ability to multi-tasks and work under pressure. Work with a spirit of continuous improvement and innovation Fluent in English and nation language. Preferred Qualifications: If you have the following characteristics, it would be a plus: Demonstrated professional growth in global regulatory affairs including communication of evolving/emerging trends and policies. Broad knowledge base across regulatory functions. Experience in influencing and negotiating with GSK personnel as well as external partners in a variety of settings. *Li-GSK Why GSK Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Agile and distributed decision-making - using evidence and applying judgement to balance pace, rigor and risk. Managing individual and team performance. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Implementing change initiatives and leading change. Sustaining energy and well-being, building resilience in teams. Continuously looking for opportunities to learn, build skills and share learning both internally and externally. Developing people and building a talent pipeline. Translating strategy into action - a compelling narrative, motivating others, setting objectives and delegation. Building strong relationships and collaboration, managing trusted stakeholder relationships internally and externally. Budgeting and forecasting, commercial and financial acumen. *This is a job description to aide in the job posting, but does not include all job evaluation details. Our goal is to be one of the world's most innovative, best performing and trusted healthcare companies. We believe that we all bring something unique to GSK and when we combine our knowledge, experiences and styles together, the impact is incredible. Come join our adventure at GSK where you will be inspired to do your best work for our patients and consumers. A place where you can be you, feel good and keep growing. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site.

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