Regulatory Affairs Manager

1 week ago

Council Of The City Of Ryde, Australia Abbott Laboratories Full time
At Abbott, we understand that proper nutrition is the foundation for living the best life possible.
That's why we develop science-based nutrition products for people of all ages.

We are behind some of the world's most trusted names in paediatric, adult and healthy-living nutritional products, including Ensure , Glucerna and Pedia Sure, as well as specialty products that help meet the nutritional requirements of people with a variety of health conditions, such as cancer-induced weight loss, diabetes and kidney disease.

This role has the overall responsibility for management of the Nutrition Regulatory Affairs function, strategy development and compilation of regulatory submissions.

It also provides regulatory advice to support the business activities by maintaining a high level of engagement with all internal and external stakeholders.


Core Job Responsibilities:
Provide leadership and strategic direction to Abbott Nutrition Pacific Asia Regulatory team for ANZ.

Manage regulatory submissions to obtain and maintain product approvals in accordance with agreed business priorities using best-in-class regulatory documentation for all types of submissions.

Develop regulatory strategies for all product registration submissions and projects for ANZ.
Manage complementary medicine/drug submissions in ANZ.

Oversee all post-approval lifecycle management activities like change control, internal system updates, emerging regulation impact to existing portfolio, ad/promo, label & license maintenance, including efficient records retention.

Interpret, analyse, and identify regulatory requirements for new projects, and provide regulatory advice to cross functional stakeholders Negotiate with regulatory authorities to facilitate review and approval of all product submissions Monitor changes in the external environment (regulatory changes) and ensure impact of any changes is assessed, potential solutions formulated and through established policies & processes Provide timely input into Abbott Nutrition positions on emerging issues/regulations and implement plans to respond, influence or mitigate potential losses, and identify opportunities in legislative/regulatory area.

Establish ongoing liaison and collaborative relationships with key government agencies and officials, as well as industry associations.
Lead technical working groups or trade association initiatives aligned with business New Product Introduction (NPI) objectives.

In conjunction with senior leadership colleagues, provide input to the business, to ensure appropriate structures, systems and values are developed.

Develop & maintain updated knowledge of applicable current global/regional nutrition regulations and applicable legislation (e.g., Codex).
Represent Abbott Nutrition in relevant international and local regulatory conferences.

Minimum Skills Required:
Good relationship building and communication skills to interact with regulatory agencies in both countries.
Strong attention to detail and ability to manage multiple project plans and timelines Analytical thinking and organizing skills Proficient in all Microsoft Tools for efficient time and project management Knowledge /

Education Required:
Science Degree or equivalent.
Additional tertiary qualifications in business management highly desirable.
Knowledge of FSANZ Food Standards Code and Australian / New Zealand Food Acts.
Knowledge of ANZ Medicine/Drug regulations is preferred.
Minimum

Experience Required:6 years of regulatory experience in food, dietary supplement, pharmaceutical or FMCG industry, with a minimum of 2 years in leadership role Demonstrated experience in working collaboratively with Regulatory agencies like FZANZ, Med Safe, TGA, and other statutory authorities such as the ACCC is desirable.

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 115,000 colleagues serve people in more than 160 countries.
Abbott is committed to building a diverse workforce that values diversity across gender, age, culture, disability and lifestyle.

In order to be eligible to work for Abbott in Australia or New Zealand, you must hold current working rights with no restrictions for the respective country applicable.

We ask that recruiters respect our internal recruitment process and PSA panel by refraining from contacting us or forwarding unsolicited profiles.

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