Sr Dir Regulatory Affairs

2 weeks ago

Navi Mumbai, India Teva Pharmaceuticals Full time

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.

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