Sr. Director, Head of Regulatory Law
2 weeks ago
COME WORK FOR US - INVESTING IN YOU AS A SUN PHARMA EMPLOYEE
Hybrid work arrangementMedical, Dental, Vision BenefitsHealth Savings Account (HSA), Flexible Spending Account (FSA) Prescription Drug CoverageTelehealth and Behavior Health ServicesIncome Protection – Short Term and Long Term Disability BenefitsRetirement Benefits - k Company Match on Day One (% vesting immediately)Group Life InsuranceWellness ProgramsCorporate Discounts on personal services: Cellular phones, Entertainment, and Consumer GoodsSun Pharma Vision: Reaching People And Touching Lives Globally As A Leading Provider Of Valued Medicines
Sun Pharmaceutical Industries Ltd. (Sun Pharma) is the fourth largest specialty generic pharmaceutical company in the world with global revenues of over $ 4.5 billion US Dollars. Supported by more than 40 manufacturing facilities, we provide high-quality, affordable medicines, trusted by healthcare professionals and patients, to more than countries across the globe including the United States. Sunology is a combination of Sun Values and Ideology and is the way of life at Sun Pharma. Sunology is Humility.Integrity.Passion.Innovation. It represents our promise to all stakeholders including patients, physicians, and employees.
Our Code of Conduct
Our Global Code of Conduct governs every aspect of our operations. Sun Pharma is a family of thousands of people, working across many countries, speaking multiple languages, and all united, with one common purpose: to make good health accessible and affordable to local communities and society at large. Through active fieldwork, dedicated research teams, and in recognition of the efforts who work behind the scenes to combat illness and disease, the Sun Pharmaceutical Group helps as many people as possible, to secure their right to good health. The way we work every day is important to us.
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The Senior Director, Head of Regulatory Law reporting to the VP, General Counsel will provide regulatory counsel to the Rx, Generic, and OTC business at Sun Pharmaceuticals, and its affiliates including Taro Pharmaceuticals.
Responsibilities
Serve as primary U.S. regulatory lawyer at Sun and Taro.Legal advisor on FDA and CMS regulatory compliance matters, including quality related issues (e.g., market actions/recalls, stop sales, quality issues/communications), FDA strategy, and on pricing, patient access, and government price reporting. Business partner to R&D, regulatory affairs, and business development teams on product development and drug approval pathways, and on R&D and commercial issues.Review marketing and promotional initiatives, programs presenting healthcare fraud and abuse risks, and product launch strategies.Advise government teams on price transparency reporting requirements. Develop, review, and approve company policies and SOPs. Review and assess state legislative initiatives, develop and recommend corporate positions, represent companies with trade association legislative/lobbying and policy committees.Serve as a senior lawyer on a collaborative and dedicated legal team.Qualifications
J.D. with a minimum of 12 years of legal experience in a law firm or in-house role focusing on life sciences, and/or related work.Commitment to excellence.Pharmaceutical and/or life science experience (or advising pharmaceutical clients at a law firm) is required. FDA experience preferred.IND
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Sr. Director, Head of Regulatory Law
2 weeks ago
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