Job Description

JOB DESCRIPTION:

MAIN PURPOSE OF ROLE

• Lead development of strategy for regulatory affairs based on company objectives and evolving regulatory environment aligned as per global guidance, company policies and legal aspect. Identify regulatory opportunities and find innovative ways to address and mitigate regulatory risks.
• Develop and maintain positive relationship with all stakeholders either internal or external including key opinion leaders and key influencers in regulatory bodies & industry associations while building Abbott Nutrition\xe2\x80\x99s credibility and trust. Provide input into developing Abbott Nutrition positions on emerging issues and implement plans to respond, influence or mitigate.
• Contribute to the overall effectiveness of Abbott Nutrition Malaysia Organisation through leadership and active participation as a member of the MY Senior Leadership Team.

MAIN RESPONSIBILITIES

Regulatory Affairs

• Drive development and management of regulatory strategy which facilitates timely access to new products/innovations.
• Build & manage a committed, accountable organization. Recruit, develop and mentor regulatory professionals ensuring an effective succession plan.
• Lead & manage Regulatory Affairs team accountabilities like timely registration/approval of current and future portfolio, product label/promo material accuracy, and ensure all post-market regulatory responsibilities of the business are fulfilled.
• Interpret and apply regulatory requirements. Provide regulatory input to product lifecycle planning and in all stages of product development.
• Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and work with appropriate teams to develop solutions.
• Strategise and influence external environment for impact on Abbott Nutrition products/business activities like regulation changes, government practices, trade association activities, among others.
• Ensure accuracy of regulatory data maintained in electronic systems.

Stakeholder Engagement

• Identify, develop & maintain positive relationships with relevant stakeholders while building Abbott credibility & trust as a leader in Nutrition & Science, as well as support the Abbott position through effective communication.
• Develop processes to monitor and utilize emerging regulatory, policy and intelligence information, including details on key networks/influencers, regulatory agencies, KOLs and other stakeholders.
• Manage key relationships within trade associations, advocate for Abbott\xe2\x80\x99s position on key topics, and take leadership role on key issues relevant to the business including leading technical committees or working groups.
• Lead and navigate regulatory strategy on ground to drive regulation change in market and key areas of interest, including stakeholder mapping, KOL engagement plans and other initiatives.
• Build new relationships and expand existing relationships with key regulatory stakeholders in Malaysia to anticipate potential challenges to business and identify opportunities to build/grow the business.

Preservation of Compliance

• Ensures compliance to SOPs relevant to market practices and required ethical standards.
• Ensure compliance with Abbott Nutrition guidelines, local regulations for the different product categories and codes of practice.

Maintenance of Knowledge Database

• Maintain an elevated level of product knowledge through familiarity with medical and scientific literature for all Abbott Nutrition products and the pipeline portfolio.
• Develops and maintains updated knowledge of applicable current global/regional nutritional regulations and guidelines (e.g., Codex, Malaysia food regulations).
• Participation in relevant external international and local regulatory/quality conferences to maintain subject matter knowledge.

People Management

• Motivate, develop, and reward a high-performance culture, aligned with HR policies and practices
• Provide regulatory advice, support, and guidance in strategic thinking to the Regulatory Affairs team
• Conduct team meetings together with Area Regulatory Affairs to share issues and contribute to building knowledge, expertise, and learning.
• Monitor responsibilities and workload of Regulatory team to ensure balance of interest and challenge for professional development and retention.
• Work with the Regulatory team to achieve continuous process improvement with aim to effectively mitigate barriers to achieving business objectives.
• Ensure that project status, regulatory update reports and stakeholder management strategies are communicated to senior leadership as required.

QUALIFICATIONS

Education

• Minimum: Bachelor\xe2\x80\x99s degree in food technology/nutrition/pharmacy/science related field.
• Preferred: Physician, Medical Degree, PhD, Master\xe2\x80\x99s degree, or advanced education in food technology/nutrition/pharmacy/science.
• Additional tertiary qualifications in business management highly desirable.

Experience/Background

• At least 10 years prior experience in Regulatory, R&D, Medical, Quality, or related area, preferably in nutrition, with a minimum of 5 years in senior leadership role with management responsibility.
• Demonstrated experience interfacing and working collaboratively with government regulatory agencies and proven skill at developing and implementing successful regulatory strategies.
• Effective communication skills to effectively present regulatory information in writing and verbally to senior management, KOLs and government agencies.
• Strategic thinking skills and being able to effectively manage a multitude of projects/issues at one time.

The base pay for this position is N/A

In specific locations, the pay range may vary from the range posted.

JOB FAMILY: Regulatory Operations

DIVISION: AN Abbott Nutrition

LOCATION: Malaysia
Selangor : Imazium, No. 8, Jalan SS 21/37

ADDITIONAL LOCATIONS:

WORK SHIFT: Standard

TRAVEL: Not specified

MEDICAL SURVEILLANCE: Not Applicable

SIGNIFICANT WORK ACTIVITIES: Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

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