Regulatory Affairs Executive (ID: 687615) - #1124973

Our client in the Pharmaceutical & Life Sciences industry is seeking to hire a Regulatory Affairs Executive to join their growing team!

• Work Location Accessible by Public Transport

• Reputable Global Organization with Strong Market Presence

• Clear Career Pathway & Progression Opportunities

Responsibilities:

• Assist to work along with internal and external units towards achieving common strategic regulatory goals.

• Provide support in regulatory affairs (RA) for product registration, variations and renewal submissions (consumer health care products e.g. OTC/generics, health supplements, cosmetics and medical device). Maintain and track the registration status of all marketed products in compliance with relevant regulations.

• Liaise with cross-functional teams including Marketing, Quality and R&D to ensure regulatory compliance across product lifecycle activities such as artwork and labeling, claims substantiation, health authority queries, new product development, and change controls.

• Stay informed of evolving regulatory requirements; assess and communicate their impact and support the supervisor in driving necessary actions to maintain compliance.

• Provide technical support and work closely with the relevant stakeholders (internal, external) on change management of raw materials/packaging materials as well as new product development (NPD) process.

• Work with the business units on NPD requirement, review and evaluate together with the technical team from manufacturing operations on the product concept/formulation/data analysis.

• Maintain a systematic archive of marketing materials (advertisements, social media posts, POSM, packaging artworks, digital and print campaigns) for each market and product.

• Ad-hoc projects and tasks assigned by the management.

Requirements:

• Degree in Pharmacy, Life Sciences, Applied Chemistry or equivalent

• At least 2 years of experience in regulatory affairs - handling product registration preferably in the pharmaceutical line, consumer healthcare products or related industry.

• Knowledge of Asia Pacific regulatory procedures & guidelines (e.g., US FDA / EMA / ICH / PIC/S framework) is an added advantage. 

• Familiar with risk management tools/principles.

• Some exposure in product innovation/NPD and/or legal agreement matter is an advantage

• Good documentation and project management skills

Interested candidates who wish to apply for the advertised position, please click on “Apply”. We regret that only shortlisted candidates will be notified.

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