Total 2 job vacancies by Abbott Laboratories (singapore ) Private Limited

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.

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 Function:

• As Associate Director, Marketing - Pacific Asia- you will provide thought leadership, coordination of innovations for our portfolio of Abbott Nutrition products in Pacific Asia region
• You will be responsible for managing innovation pipeline including: insight generation, market and product scoping, financial valuations, claims and science story development and validation amongst consumers and health care professionals, contingency planning, and commercial project lead through stage-gate processes for key Abbott Nutrition brands in Pacific Asia – Similac, Pediasure, Ensure and Glucerna.
• Market responsibilities include Vietnam, Philippines, Malaysia, Singapore, Indonesia, Australia and NZ, Japan, India, Taiwan, China, HK.

Major Responsibilities:

• Drive consumer insight development and trend spotting, working with Marketing Insights to uncover competitively differentiated and superior product, package, and other innovation ideas tied directly to resolving a consumer need state.
• Builds value propositions translating to incremental financials opportunities with demonstrable consumer interest, addressing wider market and competitive landscape consideration.
• Ensure pipeline sufficiency by planning innovation building blocks, together with contingency, to meet PA nutrition business objectives.
• Strategic prioritization of short term and longer term innovations to drive clarity on resource management, while balancing business needs
• Meet regularly with consumers and HCPs/KOLs
• Work with Global, Regional and Affiliate teams to develop regional innovation pipeline strategy and initiatives and support affiliates for individual pipelines across the brands.
• Seamlessly drive projects through the stage – gate processes, with close partnerships with cross functional teams – including R&D, Supply Chain, Project Management, Regulatory and others.
• Pulls together PIERs (Project Initiations in the system) for new product innovations with clear scoping (product, market, SKUs) and P&Ls meeting relevant financial hurdles.
• Work with business teams within PA as well as other regions to refine opportunity attractiveness for new innovation concepts, and build advocacy for projects to increase alignment, size, and scope.
• Work directly with global, regional and affiliate marketing as well as cross functional partners (Market Insights, R&D) to continually develop and execute portfolio strategy, meeting the long-term growth needs of the brands.
• Monitor industry trends and competitor activities to identify new opportunities for the company, Review competitors’ products and suppliers proposals to identify opportunities for new products or improvements to existing ones

Accountability:

• Responsible to drive insights & ideation as well as concept and claims development.
• Stringent vetting of claims, concepts and science stories amongst target consumers and health care professionals through qualitative and quantitative studies, for proven potential.
• Pull together PIERs with full scoping, financial and cross functional assessment for new projects.
• Timely delivery of key deliverables across the stage gate process for all key initiatives.
• Lead large, regional projects; may lead strategic cross-category projects.
• Market scope include South East Asia, ANZ, Japan, India, Taiwan, China, HK.

Requirements:

• Bachelor's Degree in Marketing/Business or related disciplines. MBA qualification is advantageous
• Minimum 13 years of product marketing, brand management, or/and innovation/product launch experience in nutrition or FMCG or pharma industry preferred.
• Candidates with experience in Nutrition industry advantageous
• Expert knowledge and experience in Gate-stage innovation process
• Strong grasp of core marketing concepts and successful track record of their application
• Strong analytical skills including business and financial management.
• A demonstrated leader; able to drive urgency for progress in self and others needing little direct supervision
• Experienced in handling complex projects in a matrix organization with demonstrated ability to collaborate with cross-functional teams to attain business objectives
• Experienced in working with global/area/local marketing team, and with R&D, agencies, and other key cross-functional teams
• Strong oral and written communication skills

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.