Job DescriptionManager, Regulatory AffairsBased in Malaysia, named one of the Best Companies to Work for in 2019 by HR AsiaJoin the premier biopharmaceutical company that has been in the business for more than 25 years and in AP for over 60 years.Key ResponsibilitiesDevelop and implement regulatory strategy to accelerate products and indications pipeline Drive regulatory policy shaping initiatives with local regulatory agency, trade association and other external stakeholders. Ensure regulatory support through product life cycle including labelling, CMC and dossier modifications Coordinate the preparation of post-approval regulatory documents in accordance with agreed timeframes Lead/participate in negotiations during regulatory approval processes for applications with the regulatory agencies Participate in inter-company organizations focusing on specific industry-related issues Keep abreast on all regulatory requirements (local, ASEAN, ICH, WHO), market, and industry developments Build long term effective relationships and keeps open communication with Regional / Global colleagues Monitor regulatory agencies and industry changes, trends and requirements to contribute effectively to product development and regulatory strategies Cooperate with other departments to collect information needed for recall reporting, including initial and follow-up reports, and others Contribute with regulatory support during health authority site inspections Attend inter-departmental meetings discussing product issues and priorities to develop clear and concise plans with milestones to reach the desired outcomes Participate in development of regulatory strategies for product changes, to ensure compliance with the current regulatory requirements Participate in working and industry groups to provide input to shape the regulatory landscape and maintain prospective awareness of evolving regulatory expectations Serves as a local in-house CMC expert and able to provide a specialized perspective for product life-cycle management.Education Minimum Requirement Graduates with Pharmacy degree or graduates with Science related degree eg BioMedical, Biochemistry, Pharmaceutical Science, Biotechnology etc.First class honours or high second upper degree Required Experience And SkillsRegistered pharmacist are encouraged to applyA minimum of 10 years of relevant pharmaceutical regulatory experience, preferably with MNC background, including experience in regulatory affairs policy shaping and CMCAbility to communicate well verbally and in writing to internal and external stakeholders is essentialDetail oriented, meticulous and organizedHas basic IT knowledgeAble to work within targeted timelinesAdvanced project management skillsSelf-motivated and strong commitment to achieve desired results and right first timeTeam playerWe are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.Current Employees apply HERECurrent Contingent Workers apply HERESearch Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.Employee Status RegularRelocation VISA Sponsorship Travel RequirementsFlexible Work Arrangements HybridShift Valid Driving License Hazardous Material(s) Requisition ID R282982
