Job Description

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

With minimal guidance, lead and manage applications through product development, submission and regulatory review process for timely approvals. Responsible for review of documents, preparation, submission and change management of original ANDAS, NDAs, Amendments and related correspondence to FDA. Work collaboratively with other functional areas and when required represent the regulatory affairs function through interactive communications with various internal and external stake holders. Communicate effectively and promptly to keep the management informed of any regulatory issues that affect assigned products/projects. Work in a professional manner and be accountable for assigned tasks and departmental goals. As needed, engage in self and collaborative learnings to strengthen essential competencies and to understand and implement any changing regulatory requirements.

How you\'ll spend your day

• Perform all regulatory activities for assigned projects (original applications and deficiency responses), including review of CMC documents for submission, preparation of required eCTD documents, submission compilation, content plan preparation, coordination and collaboration with other business functions such as RA Labeling and Legal group and coordination with the publishing group and post publishing reviews and quality checks.
• Meet due dates assigned for original applications and deficiency letter responses.
• Work closely with management to initiate regulatory strategy on CMC issues throughout the drug development process with a right first-time approach and during regulatory submissions and review cycles as well as supporting activities for product launch.
• Interface with R&D and other business functions on a regular basis to ensure project-specific regulatory strategy is met as agreed in a timely manner.
• Critical review of CMC documents for submission to ensure high quality documents are prepared for product submissions meeting the US regulatory requirements.
• Responsible for evaluating change controls for regulatory filing assessments in accordance with FDA guidance documents.
• Keep current with the FDA Guidance\'s/ICH regulations pertaining to GDUFA, CMC and regulatory filings.
• Identification of new trends and review practices experienced through deficiency letters and using it for regulatory strategy for future products.
• Ensures compliance with all company policies and procedures, including safety rules and regulations.
• Other projects and duties as required/assigned.

Your experience and qualifications

• Bachelor\'s degree/ master\'s degree in a scientific discipline, preferably in life sciences. B Pharm/ M. Pharm and/or MS in RA is a plus.
• 8 to 10 years in the pharmaceutical industry in RA, R&D, Analytical RD or Quality with 6+ years in Regulatory Affairs (CMC) with a strong background in the generic pharmaceutical industry. Experience of regulatory submissions and deficiency responses to US FDA a distinct advantage

Skills and Competencies

• Demonstrates competency in the business English written skills such as spelling, grammar and punctuation.
• Demonstrates good verbal and written communication skills - communicates clearly and concisely.
• Demonstrates proficiency with business and scientific software applications and electronic document systems.
• Demonstrates good organization skills and the ability to multi-task, detail oriented.
• Demonstrates the ability to establish and maintain good working relationships across cross functional groups.
• Demonstrates an understanding of ICH and US FDA guidelines and regulations.
• Demonstrates the ability to coordinate submissions independently in a time intensive situation.
• Demonstrates the ability to participate and share information and suggestions with management, peers and others.
• Demonstrates good critical and logical thinking. Able to analyze problems, identify solutions and implement recommendations.

Reports To

Sr Manager - 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.

Teva Pharmaceuticals