Sr Dir Regulatory Affairs - #978100

Teva Pharmaceuticals


Date: 1 week ago
City: Navi Mumbai, Maharashtra
Contract type: Full time
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

  • This is a critical and senior position within the global regulatory affairs team at Teva. In this multifaceted role, the incumbent will interface with the business, with other R&D functions, as well as support the VP of RA for international markets in the day to day running of the RA function.
  • The incumbent of this role will enjoy a wide range of subjective and objective authority in dealing with issues related to drug development and commercialization in the pre-submission, post-approval as well as lifecycle management settings. The ideal candidate for this position is expected to exert situational leadership in leading large geographically dispersed teams in a matrix as well as conventional setting. As a senior leader in Global Regulatory Affairs, the ideal candidate in this position is also expected to contribute towards organizational improvement and people development initiatives in the department

How You’ll Spend Your Day

  • Working with the cross functional global team to provide input into product development strategy.
  • Ensure appropriate share of voice for International Markets in the global team.
  • Oversee all the relevant APAC affiliates, and provide them relevant support in terms of resources, expertise, share of voice and mentoring.
  • Bring in strong expertise and understanding of the regulatory landscape of International Markets
  • Work closely with the VP, RA- International Markets in the capacity of Chief of Staff to provide necessary support with expertise and operational support in the day to day running of the department.
  • Work closely with commercial functions to devise appropriate regulatory strategies to support commercial needs.
  • Work with appropriate stakeholders to design and support appropriate lifecycle management strategies to support the business needs of the International Markets.
  • Represent International Markets, and Regulatory Affairs in relevant internal as well as external meetings, conferences, decision making boards etc.
  • Contribute to organizational strategy, people development initiatives, and be a role model for other regulatory professionals.

Your Experience And Qualifications

  • Master's degree in a scientific discipline, ideally in life sciences. Advanced degree (MD or Ph.D.) is an advantage
  • 12+ years of experience in regulatory affairs, with exposure to early development as well as lifecycle management. Additional experience in allied fields like clinical development is a distinct advantage.
  • Good understanding of biologics as well as small molecules (NMEs). Some understanding of advanced therapies (ATMP) is an advantage.
  • Ideally, some understanding of regulatory landscape in international markets (specially China and Japan).
  • Business savvy. Ability to work with the business.
  • 5+ years' experience of managing large multicultural teams in a geographically diverse setting.
  • Good understanding of clinical trials.

Personal Characteristics

  • Excellent communication skills – verbal as well as written.
  • Strong and compelling executive presence.
  • Assertive and tactful in managing people, relationships and situations.
  • Willing and able to travel: Frequent travel will be required within India to the various Teva offices and offsite meetings. Multiple instances of international travel will be required to individual affiliates and other international corporate events.

Reports To

Vice President, Global 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 is committed to equal opportunity in employment. It is Teva's policy that equal employment opportunity be provided without regard to age, race, creed, color, religion, sex, disability, pregnancy, medical condition, genetic information, marital status, sexual orientation, gender identity or expression, ancestry, national or ethnic origin, citizenship status, military status or status as a disabled or protected veteran, or any legally recognized status entitled to protection under applicable federal, state, or local laws.
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