Senior Manager/Associate Director, Regulatory Affairs Strategist

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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
30+ days ago