Deputy General Manager / General Manager

Job Description

The purpose of this role is to lead the Brands Clinical Program Support (CPS) team within GRA-India Strategy, providing guidance to assigned CMC activities/projects to the team of regulatory strategist which may include authoring /supporting CMC strategies & CMC contents for IND/IMPD/ROW IMPDs & NDA/MAA/ ROW dossier in support of Global team; modelling strong leadership and project management techniques to provide leadership to the team assuring a global focus of goals, strategies and plans. As a lead he/she is directly accountable for ensuring regulatory deliverables of the assigned products / projects in accordance with time, cost and quality expectations for all projects in portfolio through collaborative working relationships with global CMC leads and other stake holders. Also responsible for staff and talent development, performance management and contribute to overall management, alignment and process improvement and drive the appropriate culture and behaviors through the organization.The major duties and responsibilities are as below:

• Functions as Regulatory lead and single point of accountability for the Brands CPS regulatory CMC responsibilities assigned to the group. The responsibilities of the group includes but not limited to

• Author ROW IMPD CMC dossiers independently, in close collaboration with the CMC Lead and coordinate quality review according to internal procedures.
• Support Global Brands CMC in authoring IND and IMPD CMC dossiers
• Support Global Brands CMC in authoring of initial registration NDA/MMA and ROW CMC dossiers and submissions activities
• Assess scientific opinions and assist in developing regulatory strategies and documentation.
• Support in gathering and interpreting global clinical submission CMC requirements using systems and/or in collaboration with country regulatory leads
• Support CMC systems maintenance and publishing activities (e.g. SPA, PDM, etc.
• Support clinical activities for the existing portfolio, e.g. CMC activities to support BE, pediatric development, etc

• Manages team of regulatory strategists responsible for the assigned regulatory activities/submissions; Supports Global team for new submission programs on regulatory requirement, coordinates and presents regulatory data needs and negotiates with cross functional teams and external partners to ensure regulatory data requirement and the deliverables are met.

• Develops strong and positive working relationships with all the stakeholders including Global Brands leadership and various cross functional teams to ensure deliverables including global regulatory strategies and submissions assigned to the group.

• Supports in driving resolution of issues. Communicates issues, impact and outcomes to global regulatory management and core team in the regulatory matters including (but not limited to) assessments, strategy development, timely authoring, peer review & submission readiness to ensure business/ supply continuity.

• Represents the team in various cross functional and leadership meetings and communicates the position/standpoint on critical issues; Utilizes his/ her technical expertise/prior experience and provides regulatory advocacy and strategic inputs on regulatory matters, for the successful submission and approval of the regulatory submissions under responsibility.

• Exhibits business acumen and ensures thorough and timely completion of regulatory activities assigned to the team; influences and provides right direction/solutions to various stakeholders on regulatory matters including complex issues and where the regulations are ambiguous.

• Participates and presents perspectives to regulatory leadership discussion/decisions on process improvement initiatives; also ensures adequate regulatory support (Strategy & Submissions) for implementation/ execution of process improvement initiatives.

• Provides adequate review support and guidance to the team during strategy development and for authoring regulatory submissions to ensure effective data presentation and quality.

• Remains knowledgeable and maintains awareness about current regulations and guidance related to development projects, interprets, assesses impact on development programs and communicates to necessary functions and leadership.

• Responsible for ensuring compliance of the team to the submission standards, procedures and policies framed by Global Regulatory Affairs. Suggests, supports and implements system improvements to ensure regulatory compliance, reduce cycle time and create efficiency.

• Responsible for aggregate resource forecasting for the assigned projects/products and works in collaboration with Global Brands CMC partners to ensure that adequate resources are assigned to ongoing/upcoming projects; champions flexible approaches to ensure efficient and effective resource utilization.

• Responsible for mentoring and coaching the team; being resourceful to the team on functional and behavioral areas and ensures that learning is embedded in the organization.

Preferred Education:Masters in Pharmacy/ Ph.D. in Pharmaceutical Sciences or any other masters degree in life sciences.Preferred Experience:Minimum 15 Years in leading a group in the Regulatory Affairs function in a reputed Pharmaceutical Organization with major experience in handling new product submissions to global health authorities especially US FDA, EMA and EU authorities. Exposure to CMC strategies / submissions of clinical trail applications is preferred.Preferred Attributes:Excellent oral and written English communication skills. Strong project management and strategic problem-solving skills. Excellent interpersonal, collaborative and consensus-building skills, including diplomacy to negotiate conflicting priorities. An assertive, take-charge, proven manager with a strong results orientation, positive can do attitude, and a sense of urgency to get things done. Also takes appropriate risk and right decisions even when the complete information is not available or ambiguous. Administrative capabilities to build, motivate and manage a group.Technical Skills:

• Strong knowledge on the Regulatory requirements during both development and life-cycle management phases for US, Europe and other major markets and has expertise to oversee preparation and submission of complex regulatory submissions. Knowledge on current regulations and filings requirements for IND/IMPD and Clinical Trail requirements is preferred.
• Knowledge on ICH Quality Guidance.
• Competency in understanding and interpreting regulatory requirements and emerging regulatory landscape.
• Ability to manage complex regulatory issues and business processes; to manage a team of regulatory professionals; to consistently deliver to time, cost, and quality standards; to partner successfully with global stakeholders to achieve objectives.

• Ability to communicate complex information and analyses to a variety of scientific audiences in both verbal and written format, including to senior management.
• Ability to comprehend and summarize complex technical data.
• Ability to utilize flexible approaches to negotiate skillfully in tough situations with both internal and external groups. Gains trust quickly of other parties to the negotiations.
• Adequate level of knowledge on general standards, processes and policies of Pfizer/Pharmaceutical manufacturing Industry.

• Responsible for goal setting and performance management of direct staff and indirect staff; ensures talent development by identifying developmental needs of the team and creating opportunities to nurture talent base.

• Works with other regulatory staff to ensure application of consistent processes and policies across GRA HBU. Directly responsible for ensuring implementation of these processes and policies.

• Supports the leadership team and drives the required culture and behaviors through the organization.

Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.Regulatory Affairs #LI-PFE,

Keyskills :
budgetingprocess improvement initiativesmanagementsalescontinuous improvement facilitationequal employment opportunitybusiness developmentmarketingstatements of work sow