Regulatory Affairs Manager

Site Name: Thailand - Bangkok Posted Date: Aug 4 2022 Are you looking for a role in Regulatory Affairs that develop registration strategies of product to align with business direction? If so, this Regulatory Affairs Manager role could be an ideal opportunity to explore. This role will provide YOU the opportunity to lead key activities to progress YOUR career. These responsibilities include the following: Job Purpose: Develop registration strategies of product under own therapeutic area aligned with business direction; manage and ensure product filing for commercial competitive advantage; provide support to commercial teams. Supervise and develop competencies of Senior Registration Pharmacists, Registration Pharmacists and RA Assistants. Key Responsibilities: Assist Head of RA in formulating regulatory strategy & action plan to support Pharma & Vaccine business direction Supervise and develop competencies of Registration Pharmacists and RA Assistants Formulate product registration strategies to align with company goals; maximizing the competitive advantages of company assets Act as a business partner to leverage business opportunities through product registration planning, earliest product filing while respecting statutory and company requirements Ensure compliance with regulations and company’s policies/ guidance/ SOPs Provide support to all parties concerned in product launch, tender process, promotional materials, etc. Provide support the artwork management as a role of regulatory content owner involving in the creation, approval, and control of artwork Keep abreast of technical knowledge in regulatory affairs and related regulations Others as assigned by Head of RA e.g., special project Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Degree in Pharmacy At least 7 years in registration area in international environment Excellent in English (written and speaking) Preferred Qualifications: If you have the following characteristics, it would be a plus: Strong sense of ethics, integrity, and commitment Leadership skill to supervise and develop subordinates Capability to cope with challenges High sense of urgency and Commercial mindset Interpersonal and networking skills Analytical Thinking, Planning & Organizing Detailed-oriented Why GSK ? We prevent and treat disease with vaccines and specialty and general medicines. We focus on the science of the immune system, human genetics, and advanced technologies, investing in four core therapeutic areas (Infectious Disease, HIV, Oncology, and Immunology/ Respiratory) and future opportunities to impact health at scale. We have a broad portfolio of innovative and established medicines that treat everything from COPD to lupus and urology, as well as vaccines that help protect people at all stages of life. We are a global leader in respiratory disease and HIV, and we’re developing our presence in specialty therapy areas, including oncology and immuno-inflammation. We deliver over 20 different vaccines in more than 160 countries. From smallpox to meningitis and influenza, our vaccines have been protecting people from some of the world’s most devastating diseases for more than 100 years, and we’re continuing to develop novel vaccines across a range of pressing public health threats. 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.