- Listed Multiinational with broad portfolio of products
- Pioneering the set-up of the HQ in Singapore
About Our Client
Our client is one of the most established Pharmaceutical and Consumer Health Multinational with a strong global footprint. As part of its expansion, it has launched a new business unit to be globally headquartered here in Singapore.
- Lead the regional OTC and Health Supplements regulatory function and partner with business to drive growth ambition.
- Manage and implement Regulatory Affairs strategies, policies and objectives in accordance with Company strategic plans.
- Participate in external policy and advocacy to create, grow and protect the business. Represent company on appropriate forums.
- Develop and execute robust end to end regulatory strategy to support innovation and compliance.
- Partner with other functions like quality, supply chain to ensure timely regulatory deliveries.
- Work with external companies to ensure appropriate regulatory framework is in place to ensure end to end regulatory compliance (e.g. CGMP, labeling, advertisement, sales & distribution, claim etc.) for the business
- Work with in-house and external legal counsel to resolve product compliance conflicts, and other issues when ambiguity exists in the regulations by applying risk management principles to ensure consumer and brand protection
- Manage the pre-market registration or notification process to enable product sale.
- Provide regulatory guidance, risk assessment, and management throughout the product lifecycle: New Product Development and Commercial projects
- Ensures all governmental reporting systems and documentation comply with applicable regulatory standards and requirements for OTC drug, cosmetic, consumer and other products.
- Monitor, interpret and validate current and changing regulatory legislation and share potential impact these activities may have on the innovation/ product maintenance.
- Participate as an effective member of cross-functional product teams.
The Successful Applicant
- A Master's degree in Science or Nutrition; or strong experience in regulatory affairs with at least 10+ years experience in a regional or global regulatory affairs capacity
- Extensive knowledge and experience on OTC and health supplements regulatory and applicable laws and regulations in different regional markets, as well as of cGMP standards
- Extensive knowledge and understanding of global PV practices
- Proven regulatory advocacy skills with measurable deliverables in OTC.
- Strong analytical, prioritizing, interpersonal, problem-solving, presentation, budgeting, project management (from conception to completion), & planning skills
- Ability to develop and maintain collaborative relationships with peers and colleagues across the organization, as well as, internal and external stakeholders
- Ability to work well autonomously and within a team in a fast-paced and deadline-oriented environment.
What's on Offer
- Part of the pioneering leadership team in an established Consumer set-up
- Great work culture and a strong leadership team with a good track record of success
- Good remuneration and benefits