Regulatory Affairs, Senior Associate

WILHELM HAUFFMANN & COMPANY PTE. LTD.; Singapore; On-site; SGD 60,000 - 80,000; Full time

Job summary

A leading healthcare company in Singapore is seeking an Associate/Senior Associate with regulatory affairs experience. The role involves supporting product registration and compliance, working with cross-functional teams, and staying updated on regulatory requirements. Candidates should have a relevant degree and at least 2 years of experience in the healthcare sector.

Qualifications

• At least 2 years of product registration experience in healthcare or related industry.
• Knowledge of regulatory procedures & guidelines in Asia Pacific or US FDA is preferred.
• Familiar with risk management tools and principles.

Responsibilities

• Assist internal and external teams to achieve regulatory goals.
• Support regulatory affairs for product registration and compliance.
• Liaise with teams to ensure compliance across product lifecycle activities.
• Stay informed of regulatory requirements and assess their impact.
• Provide technical support for change management and NPD processes.

Skills

Good documentation skills

Project management skills

Interpersonal skills

Effective influencing

Problem solving skills

Education

Degree in pharmacy, life sciences/applied chemistry

Job description

WILHELM HAUFFMANN & COMPANY PTE. LTD.

Wilhelm Hauffmann is wholly owned subsidiary of Borden Eagle Singapore Pte. Ltd. for Eagle Brand consumer healthcare products (eaglebrand.com.sg) and its associated brands.

The company main activities are in research and development (R&D) of consumer healthcare products, intellectual property (IP) holder (trademarks, patents and formularies), regulatory affairs (RA), technical compliance and business development in licensing the IP.

In view of the business expansion, we are looking for associate/senior associate who has RA/NPD experience to join our team.

Roles & 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

• Possess a good degree in pharmacy, life sciences/applied chemistry or equivalent from established university.
• At least 2 years of product registration experience preferably in the pharmaceutical line, consumer healthcare products or related industry.
• Knowledge of regulatory procedures & guidelines in Asia Pacific countries / US FDA / EMA / ICH / PIC/S framework are preferred. Additional knowledge or experience in brand management, marketing compliance, or claims substantiation is an advantage.
• Good documentation and project management skill.
• Communicate openly with all stakeholders, embrace diversity of thoughts, create trustful relationships, lead and collaborate with willingness, fairness and integrity.
• Familiar with risk management tools/principles.
• Some exposure in product innovation/NPD and/or legal agreement matter is an advantage.
• Other core competencies i.e. good interpersonal skills, effective influencing, decision making and problem solving skills, time management and result-driven.