Associate Director Regulatory Affairs Diabetes Care
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Job Location:
Monthly Salary:
Posted on:
12 hours ago
Vacancies:
1 Vacancy
Job Summary
JOB DESCRIPTION:
Were focused on helping people with diabetes manage their health with life-changing products that provide accurate data to drive better-informed decisions. Were revolutionizing the way people monitor their glucose levels with our new sensing technology.
MAIN PURPOSE OF ROLE
The function of an Associate Director Regulatory Affairs is to combine knowledge of scientific regulatory and business issues to enable products that are developed manufactured and distributed to meet required legislation. Additionally the individual will develop and supervise regulatory professionals. The individual has division level influence and is generally considered a key opinion leader and an expert resource both within Abbott and externally. The individual will influence changing regulations and guidance interface with outside regulatory agencies and trade associations and provide executive management with regulatory metrics/information. The individual will plan direct and coordinate the regulatory affairs activities related to products in the Asia Pacific region.
MAIN RESPONSIBILITIES
- Builds relationship at local and regional level directly as Abbott or through Trade Associations
- Ensures that agreed regulatory strategies for Abbott Diabetes Care in the Asia Pacific region are efficiently implemented and are maintained in-line with changing regulatory needs and business needs
- Develops regulatory strategy on new product categories to allow business development in new segments
- Understands regulations regulatory procedure and related institutions as well as trend in regulations
- Develops and implements internal and external strategies to proactively influence legislation / guidelines with impact on Abbott Diabetes Care in the Asia Pacific region either directly or through Trade Associations
- Provides strategy and direction to teams involved in agency hearings at Affiliate level
- Supports product complaints anticipating authorities expected response
- Identifies areas of margin improvement
- Manages assigned budgets as appropriate
- Provides regulatory leadership and expertise to licensing colleagues
- Trains develops and manages an effective team at Area and Affiliate level
REQUIREMENTS
- Bachelors Degree in a scientific discipline (e.g. biomedical engineeringpharmacy chemistry pharmacology life science.)
- A relevant Masters Degree is preferred.
- At least 2-3 years global experience.
- 7 years of experience in regulatory preferred but may consider quality assurance research and development/support scientific affairs operations or related area.
- Experience in nutrition/medical device/pharmaceutical industry and international business.
- Expertise in due diligence Company integration and rationalization of manufacturing facilities from the regulatory perspective
- Must have the ability to convince division management at all levels to support the regulatory needs.
- Must have the ability to present complex scientific data to meet the needs of individual regulatory agencies and the scientific and management skills to negotiate.
- Routinely identifies areas of regulatory or compliance risk and establishes programs to reduce risk.
- Resourcefully directs the development of creative solutions to unusually complicated regulatory and systems problems.
- Problem solving creative and effective solution skills
The base pay for this position is
N/AIn specific locations the pay range may vary from the range posted.
JOB FAMILY:
Regulatory Operations
DIVISION:
ADC Diabetes Care
LOCATION:
Singapore > Singapore : DUO Tower
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes 15 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
Required Experience:
Director
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
WHO WE ARE CREATING LIFE-CHANGING TECHNOLOGY From removing the regular pain of fingersticks as people manage their diabetes to connecting patients to doctors with real-time information monitoring their hearts, from easing chronic pain and movement disorders to testing half the world’s ... View more
