Teva Pharmaceuticals Hiring for Associate Director Regulatory Affairs at Navi Mumbai, India Full Time

Associate Director Regulatory Affairs

Date: Sep 29, 2023

Location:

Navi Mumbai, India, 400706

Company: Teva Pharmaceuticals

Job Id: 51564

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

• We are seeking a highly skilled and detail-oriented CMC Regulatory Affairs Specialist to join our team. In this role you will be responsible for providing regulatory guidance and support for CMC activities of Innovative products across international markets.

• The primary focus of this role is to ensure compliance with applicable regulatory requirements and to facilitate the timely approval of our products for new submissions as well as maintenance activities.

• This individual will work closely with authors of dossier sections and will prepare/review and approve CMC regulatory filings to various health authorities.

How you’ll spend your day

• Collaborate with cross-functional teams such as Quality Assurance, Manufacturing, and R&D teams, to develop and implement CMC regulatory strategies and plans for new product submissions, variations, and post-approval changes.

• Prepare and review CMC sections of regulatory submissions (e.g., CTA, MAA), ensuring accuracy, completeness, and compliance with regulatory guidelines.

• Review and assess the change controls for the product under his/her responsibility to establish the regulatory impact and define the strategy for the implementation of the changes

• Prepare relevant sections for regulatory agency meetings related to CMC topics

• Coordinate responses to Health Authorities with appropriate personnel and departments to resolve outstanding regulatory issues, ensure timely and accurate submission of requested information.

• Collaborate with internal stakeholders, to ensure CMC-related documentation and processes are in alignment with regulatory requirements.

• Other duties as assigned or as business needs require

Your experience and qualifications

• Bachelor’s degree in a scientific discipline, such as Biology, Chemistry, Pharmacy, or related fields. Advanced degree (Master’s or Ph.D.) is advantage.

• 3+ years of experience in CMC regulatory affairs within the pharmaceutical industry.

• Strong knowledge of global CMC regulatory requirements and guidelines , working experience with-in International markets advantage

• Experience with preparing and reviewing CMC sections of regulatory submissions (e.g., CTA, MAA).

Reports To

Sr 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