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Director, Regulatory Affairs CMC Combination Products

Date: Jun 10, 2024

Location:

Harlow, United Kingdom, CM20 2FB

Company: Teva Pharmaceuticals

Job Id: 56483

Who we are

Together, we’re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It’s a mission that bonds our people across nearly 60 countries and a rich, diverse variety of nationalities and backgrounds. Working here means working with the world’s leading manufacturer of generic & innovative medicines, and the proud producer of many of the products on the World Health Organization’s Essential Medicines List. Today, at least 200 million people around the world take one of our medicines every single day. An amazing number, but we’re always looking for new ways to continue making a difference, and new people to make a difference with.

We have a fantastic opportunity within theGlobal Regulatory Affairs, CMC Biologics, Devices department as a Director, Regulatory Affairs CMC Combination Products to provide global regulatory CMC strategy and guidance for combination products, platform devices and assigned marketed products, as well as those assigned products that are currently in development.

Location: we are happy to consider candidates based close to one of our sites in the UK (Harlow, Ridings Point, Runcorn, Larne) or Ireland (Waterford, Swords).

We have a hybrid approach to home-working!

A day in the life of a Director, Regulatory Affairs CMC Combination Products...

• Provide accurate and timely device specific regulatory guidance to teams engaged in the development and lifecycle of drug device combination products and devices by assessing and interpreting global regulatory guidance’s and directives and evaluating and communicating their applicability to the development teams.

• Support the development and communications of effective device and combination product platform related regulatory strategies for development and post marketing submission activities. Determine and communicate appropriate device and combination product related risk analyses and timeline development.

• Collaborates with the Cross Functional Digital Health, Commercial, Quality, Combination Product development teams through progression of internal developmental programs.

• Coordinate, support, author and/or review the Device platform specific agency interaction. Assist in the submission of regulatory correspondence to the agencies.

• Assist in planning and conducting meetings with regulatory agencies and Notified Bodies to support Device related activities.

• Review Device specific regulatory documents as needed. Including but not limited to Development Reports, Validation Protocols, standard operating procedures, test methods, specifications, protocols and reports, and responses to agencies information requests.

• Support the Global Regulatory Affairs (GRA) CMC team for the global initiative for marketed products and assist with the preparation of a complete registration dossiers to be submitted to the Health Authorities.

• Ensure global consistent change management and compliance of regulatory commitments.

• Keeping oversight of Global Device related Regulations and providing consolidated training and consultancy to Subject Matter Experts (SMEs) and GRA.

• Organizing and sharing of knowledge associated with medical devices.

• Supporting GRA functions with and keeping central track /documentation of authority requests e.g. Notified Body Opinion, Commitments, categorization of products.

• Ensuring adequate Change control and complaints management for devices /device components from a global RA perspective in collaboration with Quality Assurance (QA) and Pharmacovigilance (PV).

• Ensuring adequate and efficient processes to obtain device specific documentation.

• Leveraging synergies and harmonization across business units, functions and roles within GRA including establishing overarching work instructions/business practices

• Representing Teva at Industry Associations and Conferences.

• The Device Regulatory Affairs CMC Director is also responsible for maintaining and updating internal platform device strategy documents and Device relevant sections of submissions for Teva products.

• Identify, propose, and implement improvements and simplification of processes in connection with other relevant functions and key stakeholders.

• Advocate for harmonization in processes across the organization.

• Participate in Quality/Regulatory governance meetings for managerial oversight of device compliance and change management.

• Monitor regulatory compliance using applicable metrics and KPIs.

Who we are looking for

Do you have...?

• Bachelor’s degree in scientific discipline (must have). Advanced degree (M.Sci., Ph.D., PharmD) is preferred.

• At least 7 years of pharmaceutical and/or Device industry experience (must have)

• Relevant technical experience in Combination Products, Digital Health Products, Analytical (QC, Analytical R&D), process/product development, or manufacturing is preferred.

• Management experience in Regulatory Affairs.

• Knowledge of ISO, US, EU and ICH Regulatory guidelines

• Experience with eCTD regulatory filings.

• Knowledge of US and global content and regional requirements

• Knowledgeable in drug development processes and life cycle management of products

• Clear, concise technical writing skills

• Good interpersonal, communication and organizational skills.

Are you...?

• Able to manage multiple projects and competing timelines.

• Able to assess regulatory requirements and filing timelines in order to judge the work required for submission of a quality filing.

• Able to assess technical quality of documents and to provide regulatory feedback to colleagues.

• Able to respond quickly with reasonable solutions and alternatives to regulatory-related problems.

Reports To

Senior Director, Global RA CMC

Already Working @TEVA?

If you are a current Teva employee, please apply using the internal career site available on "Employee Central". By doing so, your application will be treated with priority. You will also be able to see opportunities that are open exclusively to Teva employees. Use the following link to search and apply:Internal Career Site (https://performancemanager.successfactors.eu/sf/careers/jobsearch?bplte_company=1080030P)

The internal career site is available from your home network as well. If you have trouble accessing your EC account, please contact your local HR/IT partner.

Teva’s Equal Employment Opportunity Commitment

Teva Pharmaceuticals is committed to equal opportunity in employment. It is Teva's global policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, sexual orientation, gender identity or expression, ancestry, veteran status, national or ethnic origin or any other legally recognized status entitled to protection under applicable laws. We are committed to a diverse and inclusive workplace for all. If you are contacted for a job opportunity, please advise us of any accommodations needed to support you throughout the recruitment and selection process. All accommodation information provided will be treated as confidential and used only for the purpose of providing an accessible candidate experience.#TJ

EOE including disability/veteran