We are Reckitt
Home to the world's best loved and trusted hygiene, health, and nutrition brands. Our purpose defines why we exist: to protect, heal and nurture in the relentless pursuit of a cleaner, healthier world. We are a global team united by this purpose.
Join us in our fight to make access to the highest quality hygiene, wellness, and nourishment a right and not a privilege.
About the roleAs a Regulatory Associate, you're at the forefront of shaping the synergy between our innovative products and the regulatory framework that guides them. Seeking a meticulous and proactive individual, this role offers you the chance to be the regulatory lead on pivotal projects, honing your communication skills, and nurturing robust partnerships — all while delivering critical tasks that influence our global presence. Your contributions will be impactful and meaningful, as you begin to navigate and influence the regulatory scenery that defines our industry.
Your responsibilitiesAs a Drug Safety Officer (DSO) of the company and lead the vigilance activities (such as AE reporting and submission of PBRER to local authority).
Assist Regulatory Affairs Director in providing regulatory activities and product safety support for Reckitt products (Health category).
Lead the on-going regulatory compliance, notification, and registration of Reckitt products and co-ordinate the resolution of regulatory, medical and product safety issues affecting assigned Reckitt category in the country.
Liaise with a range of colleagues from Country marketing, R&D, supply, and global/regional regulatory teams, and work closely with external partners, contractors and licensees to ensure that regulatory, safety and medical affairs issues are properly managed and resolved.
Ensure the registration and regulatory compliance of Reckitt's marketed products with relevant national regulatory requirements to bring competitive advantage to our brands.
Compilation of registration dossiers for submissions to authorities.
Amend the registration dossiers as necessary for country-specific regulatory requirements and overseeing the submission of registration/variation applications and negotiating with governmental authorities to obtain rapid approvals.
Monitoring and interpreting local regulatory issues and trends that will impact the marketability of company products, ensuring that the company is aware of significant local regulatory issues, and proactively leading the development and implementation of strategies to ensure regulatory compliance efforts that result in competitive advantage.
The experience we're looking forLanguage skills: Fluent in English and Malay language.
Registered with Malaysia Pharmacy Board.
Minimum 5 years experience in Pharmacovigilance (PV) of pharmaceutical industry and Regulatory Affairs in FMCG or Healthcare.
Broad knowledge of Malaysia and East Asia regulatory and healthcare systems.
Experience in handling issues resolution in regulatory affairs.
Clear and logical thinker with the ability to recognize patterns and develop innovative solutions.
Pro-active self-direction with a high level of initiative and persistence and a very much hands-on approach to results delivery.
What we offerWith inclusion at the heart of everything we do, working alongside our four global Employee Resource Groups, we support our people at every step of their career journey, helping them to succeed in their own individual way.
We invest in the wellbeing of our people through parental benefits, an Employee Assistance Program to promote mental health, and life insurance for all employees globally. We have a range of other benefits in line with the local market. Through our global share plans we offer the opportunity to save and share in Reckitt's potential future successes. For eligible roles, we also offer short-term incentives to recognise, appreciate and reward your work for delivering outstanding results. You will be rewarded in line with Reckitt's pay for performance philosophy.
EqualityWe recognise that in real life, great people don't always 'tick all the boxes'. That's why we hire for potential as well as experience. Even if you don't meet every point on the job description, if this role and our company feels like a good fit for you, we still want to hear from you.
All qualified applicants will receive consideration for employment without regard to age, disability or medical condition; colour, ethnicity, race, citizenship, and national origin; religion, faith; pregnancy, family status and caring responsibilities; sexual orientation; sex, gender identity, gender expression, and transgender identity; protected veteran status; size or any other basis protected by appropriate law.#J-18808-Ljbffr