Manager Regulatory Affairs
Date: Feb 19, 2024
Location:
Navi Mumbai, India, 400706
Company: Teva Pharmaceuticals
Job Id: 54253
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
The Mgr (Mgr) within RA will be leading selected group of employees within RA Mumbai. The main responsibility is to oversee the projects within the team, support the team as needed and advice and help out with prioritization of projects as well as taking responsibility on other specific projects.
The Mgr will be responsible for the RA lifecycle management on dossiers and Teva’s 3rd party client business (Medis), ensuring information flow and provision of supportive documents reaches the clients.
The Mgr is responsible for liaison with supply chain, Teva site RA and other relevant functions within the company.
How you’ll spend your day
To ensure a cohesive and smooth functioning of Teva’s 3rd party client business (Medis)RA Team in Mumbai
To ensure variations are filed as per the plan by team members.
To ensure renewals are filed for Clients and Service Company as per the plan by team member.
To ensure Regulatory compliance files are updated as per the plan by team members.
To ensure enhanced collaboration and knowledge sharing by team members
Allocate and oversee projects within the team, provide support to team members as needed.
Training of team members
Ensure systems are kept up to date and working instructions are being followed.
Goal setting and performance review of the team
Close monitoring on the teams KPIs
Regular status updates to management
Writing and update SOP/Work Instructions and contributes to process improvements.
Provide regulatory guidance and support to other functions andTeva’s 3rd party client business (Medis)
Professional communications with both internal and external stakeholders
Work on other specialized projects as defined by managers of RA.
Your experience and qualifications
6-12 years in RA
M Pharm/ MSc: Not less than 6 years of experience in RA
B Pharm/BSc: Not less than 8 years of experience in RA
Personal Characteristics
Excellent organization skills
Excellent communication and presentation skills
Excellent written and verbal knowledge in English
Strategic thinking and flexibility to adapt to changes.
Strong team player
Good computer skills
Proactive way of working and able to work independently.
Good management skills
Reports To
Director – Regulatory Affairs
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.
EOE including disability/veteran
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