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Mgr Regulatory Affairs

Teva PharmaceuticalsBangalore, India

20 days ago

Job description

The opportunity

The manager is responsible for the supervision, preparation, and critical review of high quality regulatory submissions to the regulatory agencies within company timelines and in accordance with regulatory guidelines. The manager evaluates complex regulatory issues and provides accurate and timely recommendations and alternatives, as needed, to his / her supervisor. The manager will be the product manager for the assigned products and will manage life cycle management activities such as variations, renewals, responses to HA queries and prepare packages for submission to Health Authorities in the required markets. He / she will help to establish regulatory strategies for submissions and manage document deliverables to ensure submission targets are met while adhering to appropriate regulations and guidance’s. The manager will oversee any / all regulatory or team databases and trackers and will accurately update them when changes are required. The product portfolio will cover mature innovative medicines.

How you’ll spend your day

Plans Regulatory Submission Tracker of all Life Cycle Management activities Worldwide Markets for the assigned products.
Prepare submission strategy as per regulatory requirements in the given markets and works with cross functional teams for final package creation. Manages all operational activities as needed in Teva regulatory systems.
Serves as regulatory representative and works closely with Worldwide markets to ensure timely submission; Maintains collaborative partnerships with stakeholders.
Scope of Life Cycle Management Activities include all variations, renewals, PSURs, DSURs, RMPs and responses to queries from Health Authorities (EU / US / APAC / Other Markets)
Provides input to KPI metrics for submissions and approvals
Other projects and duties as required / assigned.

Your experience and qualifications

Pharm D / MS in a scientific discipline or equivalent education and related experience

Master’s degree in RA / QA discipline, a plus.

Prior experience in managing life cycle management regulatory activities a plus; Ability to work independently and in a global environment with strong communication skills

Minimum 8 years pharmaceutical industry experience required; 5+ years Regulatory Affairs experience required with experience in EU / US / Worldwide markets for Manager Role, 8+ years for Senior Manager position

Demonstrates an understanding of ICH and Regulatory Guidelines for US, EU and APAC markets.

Demonstrates the ability to evaluate regulatory documents and determine appropriate action.

Demonstrates excellent verbal and written communication skills.

Shares concepts, ideas, information, and suggestions with management, peers and others.

Demonstrates the ability to establish and maintain good working relationships at all levels of the company and with external contacts.

Demonstrates excellent organization skills and the ability to multi-task; detail oriented.

Possesses strong critical and logical thinking.

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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Mgr • Bangalore, India