Regulatory Affairs Executive

3 days ago

Bukit Merah, Singapore 10c81105-27cc-4820-82ae-b684421b536c Full time $80,000 - $120,000 per year

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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