Job Description

Regulatory Affairs Associate I

Date: Oct 4, 2023



Location: Navi Mumbai, India, 400706



Company: Teva Pharmaceuticals



Job Id: 51601

Who we are

Together, we\xe2\x80\x99re on a mission to make good health more affordable and accessible, to help millions around the world enjoy healthier lives. It\xe2\x80\x99s 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\xe2\x80\x99s leading manufacturer of generic medicines, and the proud producer of many of the products on the World Health Organization\xe2\x80\x99s 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\xe2\x80\x99re always looking for new ways to continue making a difference, and new people to make a difference with.

The opportunity

Providing regulatory support for European and International Markets RA.

How you\xe2\x80\x99ll spend your day

• Completion of designated projects and tasks supporting European Market RA and International Market RA, according to internal Work Instructions, with a guidance and direction by the manager and more senior colleagues.
• Maintaining related documentation and regulatory IT systems, in line with internal procedures.
• Communication with Teva units across Europe and International Markets, with 3rd Parties and with related Health Authorities.
• Fulfilling other allocated department duties and ad-hoc tasks as directed by senior regulatory affairs staff.
• Completion of trainings assigned in Teva internal learning management system within defined timeframes.
• Attending team meetings and providing regular updates on the assigned activities and tasks to the manager and/or to senior regulatory affairs staff.
• Maintaining and developing awareness of the current/pending regulatory legislation and guidelines.

Your experience and qualifications

Qualifications:

• M Pharm/MSc
• B Pharm/BSc

College or University degree or equivalent work experience that provide knowledge of and exposure to fundamental theories, principles and concepts.
Experience:

• 1-3 years of experience in the Pharmaceutical Industry, ideally within Regulatory Affairs but R&D, Development or QA would be considered.
• Experience of regulatory documentation within Europe and/or International Markets.

Knowledge:

• Work experience involving basic regulatory concepts and procedures.
• Ability to use existing internal procedures to solve routine or standard problems.
• Proficiency with regulatory IT systems.
• Basic knowledge of project management.
• Ability to organize own workload to meet departmental/company targets.
• Ability to identify a problem or need for decision that exceeds the competence of the individual.
• French and/or German language proficiency will be an added advantage, but not a must.

Skills

• Writing proficiency (English + local language).
• Good communication skills.
• Presentation skills.
• Attention to details.
• Ability to work under pressure and to tight timelines.

Reports To

Manager- Regulatory Affairs

Teva\xe2\x80\x99s 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.