Associate Director Regulatory Affairs – APAC – Diabetes Care

Industry:

Company: Abbott

Abbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals and branded generic medicines. Our 114,000 colleagues serve people in more than 160 countries.

JOB DESCRIPTION:

About Abbott

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.

Working at Abbott

At Abbott, you can do work that matters, grow, and learn, care for yourself and family, be your true self and live a full life. You’ll also have access to:

• Career development with an international company where you can grow the career you dream of.
• Free medical coverage for employees* via the Health Investment Plan (HIP) PPO
• An excellent retirement savings plan with high employer contribution
• Tuition reimbursement, the Freedom 2 Save student debt program and FreeU education benefit – an affordable and convenient path to getting a bachelor’s degree.
• A company recognized as a great place to work in dozens of countries around the world and named one of the most admired companies in the world by Fortune.
• A company that is recognized as one of the best big companies to work for as well as a best place to work for diversity, working mothers, female executives, and scientists.

The Opportunity

This Associate Director Regulatory Affairs – APAC will work on-site at our Alameda, CA, location in the Diabetes Division.

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.
• Minimum 5 years’ experience in a regulated industry.

Preferred Qualifications

• Bachelor’s Degree in science, math or medical fields.
• 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.

Apply Now

* Participants who complete a short wellness assessment qualify for FREE coverage in our HIP PPO medical plan. Free coverage applies in the next calendar year.

Learn more about our health and wellness benefits, which provide the security to help you and your family live full lives: www.abbottbenefits.com

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.

Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews.Connect with us at www.abbott.com, on Facebook at www.facebook.com/Abbott and on Twitter @AbbottNews and @AbbottGlobal.

The base pay for this position is
$144,100.00 – $288,300.00
In specific locations, the pay range may vary from the range posted.

JOB FAMILY:
Regulatory Operations

DIVISION:
ADC Diabetes Care

LOCATION:
United States > Alameda : 1360-1380 South Loop Road

ADDITIONAL LOCATIONS:

WORK SHIFT:
Standard

TRAVEL:
Yes, 25 % of the Time

MEDICAL SURVEILLANCE:
No

SIGNIFICANT WORK ACTIVITIES:
Awkward/forceful/repetitive (arms above shoulder, bent wrists), Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)

Abbott is an Equal Opportunity Employer of Minorities/Women/Individuals with Disabilities/Protected Veterans.

EEO is the Law link – English: http://webstorage.abbott.com/common/External/EEO_English.pdf

EEO is the Law link – Espanol: http://webstorage.abbott.com/common/External/EEO_Spanish.pdf