Regulatory Affairs Manager

Abbott Laboratories (Dublin, Ireland) 23 days ago

JOB DESCRIPTION:

About 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 107,000 colleagues serve people in more than 160 countries.

Abbott serves the Irish market with a diverse range of healthcare products including diagnostics, medical devices and nutritionals products. In Ireland, Abbott employs over 4,000 people across nine sites. We have six manufacturing facilities located in Clonmel, Cootehill, Donegal, Longford and Sligo and a third-party manufacturing management operation in Sligo. Abbott has commercial, support operations and shared services in Dublin and Galway. We have been operating in Ireland since 1946.

Abbott Ireland Commercial  Liffey Valley Dublin

Opened in 1946, this operation, based in Liffey Valley Dublin was the first Abbott business unit to be established in Ireland. This business is responsible for the sales, marketing and distribution of a wide range of diabetes, diagnostic, and nutritional products in Ireland.

PRIMARY JOB FUNCTION:

  • Develop and implement regulatory strategy for registration and reimbursement of new products, in close collaboration with relevant Departments (Marketing, Sales, Medical, etc.) and taking into account business strategy and regulatory requirements

  • Ensure maintenance of in-line products and support new business opportunities

  • Influence, monitor and implement new regulations to support business maintenance and growth.

  • Maintain and strengthen engagement with relevant authorities, regulators and government stakeholders, industry associations, opinion leaders, etc. to support appropriate regulatory and reimbursement environment

CORE JOB RESPONSIBILITIES

- Product registration, and reimbursement, launch and maintenance

  • Development of regulatory strategies for registration approval including novel ingredients as per business needs (assessment of formulas, advice on product category, handle tactics and submission timing, verification of label claims, setting mitigation plans, etc.)

  • Negotiate with regulatory authorities during the review process to ensure registration and reimbursement approval

  • Support design and execution of local acceptability studies to support reimbursement applications

  • Provide regulatory support to commercial division in all areas pertaining to product life-cycle management and new product development and introduction

  • Effectively participate in NPI project teams and ensure timely completion of tasks and clear communication of regulatory risks and opportunities

  • Ensure implementation of new regulations/guidance within legal deadlines

  • Approval of labels, advertising and promo materials ensuring alignment with local regulations, Codes of Conduct, SOPs, etc.

- External Engagement:

  • Develop a network of relevant regulators, key opinion leaders and industry peers to support and influence regulatory and reimbursement environment in alignment with business model.

  • Analyse/negotiate documents/positions put together as AN and within Trade Associations for current and upcoming regulations and assess/influence impact for ANI  business to be used  for local outreach

  • Assess and communicate impact of relevant regional regulations/standards in local market

  • Establish and maintain relations with KOLS (individual meetings, conferences, congresses)

  • Monitor emerging issues and identify solutions

- Management of crisis situations/quality events

  • Oversee system to ensure that product safety issues and product-associated events are reported as needed

  • Represent Regulatory Affairs in product recall and communication process in country under responsibility

- Management of RA budget

- Scope is regulatory direction in Ireland for:

  • Product development and support to develop most rapid successful strategy for approval to market products to meet business objectives

  • Administer /meet regulatory requirements to achieve excellent compliance status with no enforcement actions. 

  • Must assure that all deadlines are met and provide effective leadership

  • Individual is able to work independently and in from different location from manager, peers, etc.

  • Completed work is reviewed from a relatively long- term perspective for desired results. 

  • Individual is recognized as an industry expert and resource in regulatory affairs.

  • Interfaces with a variety of management levels including senior management on significant matters

  • Provides technical leadership to business units

EDUCATION & COMPETENCIES:

  • Bachelor's degree (or equivalent) in science (biology, chemistry, microbiology, medical technology, pharmacy, pharmacology, etc.)

  • Registered dietitian (with CORU) preferred.

  • 3-5 years experience in a regulated industry (e.g., medical products, nutritionals).

  • 2-3 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 

  • Excellent written English and communication skills

  • Highly developed project management skills

  • Excellent problem solving skills

  • Understanding the business

Connect with us at [...] on LinkedIn at [...] on Facebook at [...] on Twitter @AbbottNews and @AbbottGlobal.

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JOB FAMILY:

Regulatory Operations

DIVISION:

AN Abbott Nutrition

LOCATION:

Ireland > Dublin : Block B

ADDITIONAL LOCATIONS:

WORK SHIFT:

Ie - 35.0Hst0 (Ireland)

TRAVEL:

No

MEDICAL SURVEILLANCE:

No

SIGNIFICANT WORK ACTIVITIES:

Not Applicable

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