Total 2 corporate affairs executive job vacancies in D06 Beach Road, High Street

he Opportunity

As a manager, the function of an Associate Director Regulatory Affairs, APAC (Asia Pacific) is to combine knowledge of scientific, regulatory and business issues to enable products that are developed, manufactured or distributed to meet required legislation. Additionally, the individual may develop and supervise regulatory professionals. The individual has department level influence and is generally recognized as an expert resource both within Abbott and externally. The individual may comment on changing regulations and guidance, interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information. The individual may ensure that data are identified, obtained and effectively presented for the registration of products in APAC.

What You’ll Work On

• Identify need for new regulatory policies, processes and SOPs in APAC and approve them.
• Develop and advance the organizations policy and procedures for regulatory affairs and compliance to establish a compliant culture.
• Anticipate regulatory and related obstacles and emerging issues throughout the product lifecycle.
• Analyze and compare regulatory outcomes with initial product concepts and recommend future strategies and actions.
• Develop APAC regulatory strategies and update based upon regulatory changes.
• Conduct regulatory due diligence for potential and new acquisitions and advise management.
• Utilize technical regulatory skills to propose strategies on complex issues.
• Integrate regulatory considerations into the APAC product entry and exit strategy.
• Recruit, develop and manage regulatory professionals.
• Provide guidance for resource and development planning
• Approve regulatory filing strategies based upon proposed preclinical, clinical and manufacturing charges.
• Review and approve labeling to ensure compliance.
• Represent regulatory affairs in product recall and recall communication process in APAC.
• Provide strategic input and technical guidance on regulatory authority queries.
• Oversee processes involved with maintaining annual licenses, registrations, listings and patent information.
• Create project plans and timelines.
• Lead cross functional groups in the development of relevant data to complete a regulatory submission.
• Develop and communicate a vision for the organizational unit assigned.
• Administer/meet regulatory requirements to achieve excellent compliance status with no enforcement actions.
• Negotiate with regulatory authorities during the development and review process to ensure submission approval.
• Write and edit technical documents.
• Ensure compliance with product post-marketing approval requirements
• Review and approve advertising and promotional items to ensure regulatory compliance.

Required Qualifications

• Bachelor's Degree, preferably in science, math or medical fields
• Minimum 10 years’ experience in a regulated industry.

Preferred Qualifications

• Masters in technical area or MBA
• Minimum 5+ years’ experience in regulatory affairs.
• Experience working with Medical Devices, software, or combination products.
• Experience working in supporting APAC region.
• Ability to communicate both orally and in writing in Chinese, Japanese and/or other Asian language.
• RAPS Certification.

Job Description

Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.

Our nutrition business develops science-based nutrition products for people of all ages, from helping babies and children grow, to keeping adult bodies strong and active. Millions of people around the world count on our leading brands – including Similac®, PediaSure®, Pedialyte®, Ensure®, Glucerna® and ZonePerfect® – to help get the nutrients they need to live their healthiest life.

Primary Overview:

• Monitor and partner with stakeholders to influence and shape Regulatory environment.
• Proactively monitor emerging regulatory issues and develop a plan of action to mitigate adverse impacts to Abbott Nutrition (ANI) business.
• Manage key regulatory programs, particularly those with unique regulatory strategies and position
• Work closely with commercial and marketing teams to understand and support their business plans.
• Engage and collaborate with ANRA, Affiliate QA, R&D, Medical Affairs, Legal and Corporate Affairs to protect our brands and launch new products.
• Plan and execute an effective regional regulatory strategy that will support timely registration/approval of new and innovative ANI products in Singapore.
• Analyzing and identifying regulatory requirements against project needs.
• Communicating registration requirements prior to and during R&D cycle to ensure technical dossiers are effectively presented to the regulatory agencies for timely registration/approval of new products.

Major Responsibilities:

• Build good relationship and dialogue while earning trust and credibility with KOLs and key influencers in regulatory agencies and other stakeholders.
• Maintain keen awareness of regulatory environment to help share RA environment and assess challenges and solutions and communicate to appropriate stakeholders to ensure product compliance and support product launches.
• Deploy proven communication skills to effectively present scientific information in writing and verbally to management, KOLs and government agencies.
• Participate and contribute to selective scientific and trade organizations to shape our positions on innovation, safety and benefits of nutrition products based on sound scientific evidence and to promote food and nutrition standards and regulations.
• Plan and implement regulatory activities including development, presentation, and review of required regulatory documents to support new product registrations / addition in hospital formulary.
• Ensure requirements for effective approvals and registrations are met in a timely manner.
• Review and maintain regulatory documents and files (including product label, promotional materials and registration packages); record product filing, approvals, and registration activities for new products.
• Execute plans, complete tasks according to priorities set by manager, align work with business goals, and align actions with agreed strategies.
• Assure promotional and marketing materials compliance.

Supervisory/Management Responsibilities:

• Direct interaction with RA functions including Strategic Area, Regulatory Innovation and Regulatory Science and other functions such as R&D, Medical Affairs, Quality, Legal and Corporate Affairs.
• Develop and manage regulatory professionals

Requirements:

• Bachelor’s Degree in Nutrition/Science related field. Masters degree is advantageous.
• Minimum 10 years of experience in regulatory affairs in nutrition/food industry
• Good understanding and working experience in different regulatory environment in Singapore
• Good knowledge and understanding of scientific aspects of nutritional products including safety and benefits
• Proven track record of successful registration filing process of new nutrition products including novel petitions
• Ability to manage and prioritize multiple projects
• Ability to understand, compile and synthesize complex scientific data and articulate safety and benefits of ANI products
• Effective communication, presentation and persuasion skills
• Adaptable in cultural and political diversity
• Strong team player
• Capacity to learn and challenge status quo
• Self-motivated

Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.