Regulatory Affairs Associate I

None years

Not Disclosed

13 June 4, 2024

Job Description

Job Type: Full Time Education: B.Sc./ M.Sc./ M.Pharm/ B.Pharm/ Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, ICD-10 CM, CPT, HCPCS Coding, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

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 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.

The opportunity

To organize and perform required regulatory tasks in order to maintain existing EU procedures in line with current regulations, guidelines and in-house standard
To obtain regulatory approvals for defined European procedures, ensuring high quality data and standards are used in all regulatory application
To ensure high quality documents and standards are used in preparation of all regulatory applications to achieve rapid and successful assessment.
To give regulatory support to project teams, stakeholders and other sites, as require

How you’ll spend your day

Prepare, compile, review and submit high quality submissions for all required post-approval activities in accordance with EU legislation and in-house standards.
Responsibility for MA compliance with both legislation and business needs.
Prioritize, plan and monitor submissions for allocated procedures while documenting and informing involved parties of progress.
Ensure approvals are secured within the stipulated timelines for designated projects.
Maintain registration documentation and associated electronic databases, in line with in-house procedures.
Provide regulatory support and product information for all internal and external customers, stakeholders and TEVA project teams.
Communicate with other Teva departments across Europe and European Agencies regarding proposed and pending submissions.
Maintain and develop awareness of current/pending regulatory legislation and guidelines.
Fulfilling other allocated department duties and ad-hoc needs at the direction of Senior Regulatory Affairs personnel.
Awareness of current/pending regulatory legislation and guidelines.

Your experience and qualifications

Degree/ Master in Pharmacy or Master in Science/ Life science
Relevant years of experience required: 2 to 3 years in Regulatory affairs with EU post approval
Overall Pharma Industry experience: 2 to 3 years
Desirable to have EU member state experience and knowledge of European regulatory procedures.

Knowledge and Skills required

Understanding of processes and departments within a pharmaceutical company.
Good oral and written communication
Ability to work under pressure and to tight time deadlines
Effective time and organization management
Initiative
Analytical (Data and Documentation)
Computer literacy
Teamwork and collaboration
Attention to detail
Planning and Organization

Reports To

Manager Regulatory Affairs

Already Working @TEVA?

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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.

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Regulatory Affairs Associate I

Job Description

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