Senior Manager/Associate Director, Regulatory Affairs Strategist

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• Hybrid work arrangement
• Medical, Dental, Vision Benefits
• Health Savings Account (HSA), Flexible Spending Account (FSA)
• Prescription Drug Coverage
• Telehealth and Behavior Health Services
• Income Protection - Short Term and Long Term Disability Benefits
• Retirement Benefits - 401k Company Match on Day One (100% vesting immediately)
• Group Life Insurance
• Wellness Programs
• Corporate Discounts on personal services: Cellular phones, Entertainment, and Consumer Goods!

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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 100 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.
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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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Sr. Manager/Associate Director, Regulatory Affairs Strategist
The Sr. Manager/Associate Director, Regulatory Strategist is responsible for the assigned branded programs and all strategic decisions to include providing regulatory pathway for the development, preview of clinical, non-clinical and CMC development as needed, act as US agent and communicate with the agency, interact suitably with CROs and all other stakeholders as applicable.
Responsibilities:

• Serve as key corporate regulatory contact and source of regulatory information and guidance for US market (US agent) and other markets as applicable.
• Provide strategic, tactical, and operational direction and guidance for Sun Pharma products pipeline and key regulatory milestones.
• Responsible for developing, executing, and maintaining the regulatory commitments and requirements for assigned programs.
• Stay abreast of regulatory agency regulations, directives, guidelines and policies, etc. that could have an impact on product development to assess approval pathways and issues.
• Identify and communicate all issues to management related to product development that could impact product submission, approval, and product launch.
• Set and monitor submission timelines along with other key stakeholders.
• Facilitate and lead all communications with Regulatory Agencies / Health Authority as applicable.
• Ensure communication with the regulatory body are in accordance with established procedure within the department.
• At times, there may be the need for other functional areas to have a discussion with the Health Authority with their counterparts at the regulatory agency. The Regulatory Strategist/Lead should always be the point of contact and lead this interaction.
• Ensure that communication that is documented per established procedure should be distributed within the Global Regulatory Affairs team and any other external department that is directly affected by the communication.
• Must be involved in writing or to facilitate the authoring of certain regulatory sections of product submissions.
• Develops and manages relationships with external regulatory agencies, industry groups and business partners.
• As applicable, shall review the audit reports, Regulatory Agency inspection reports and responses to the inspection observations if any, when received at Sun Pharma.
• To compile, prepare, and review regulatory submissions to regulatory agencies as applicable.
• Conduct department level training, as necessary, to educate regulatory strategists and other roles in the department on regulatory requirements, policies, and procedures.
• Participate in authoring and/or reviewing of the departmental procedure as applicable

Qualifications:

• Post-graduation in Clinical Pharmacy or similar is required
• PhD will be preferable
• Specialization in project management/general management required
• 10 years of experience in a similar capacity