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CMC 3 SME


Short Hills, New jersey


CMC 3 SME Job Opening in Short Hills, New jersey - Working as part of the Genpact Pharmalink team gives you a career that will be varied, diverse and never dull! You will be joining a team of the best Regulatory Affairs Professionals in the industry, some of the most experienced and progressive minds. Our consultants come from a wide spectrum within the Healthcare Industry, all bringing invaluable skills and attributes that allow us to provide the best Regulatory Affairs expertise to our clients. Genpact Pharmlink is a highly specialized Regulatory Affairs Consultancy with a successful history. We have grown and developed our service offering through building relationships, listening to our clients? needs and adapting our ways of working to meet the changing needs of regulatory markets around the world. It is this flexibility and adaptability that we look for in all of our Consultants, which will allow us to continue to provide the level of service our clients have come to expect from Genpact Pharmalink. The success of Genpact Pharmalink depends on its people. Capitalizing on what is unique about individuals and drawing on their different perspectives and experiences will add value to the way we do business. By accessing, recruiting and developing talent from the widest possible talent pool we can gain an insight into different markets and generate greater creativity in anticipating employee and client needs.
Reporting to the Director, the Associate Director is responsible for developing and implementing CMC regulatory strategies for assigned pharmaceutical products in accordance with global regulations and guidance?s. The Associate Director will lead the preparation and submission of CMC dossiers for life-cycle changes to commercial products. The Associate Director may manage a team of 2 to 4 individual contributors in support of project execution.
Role and Responsibilities:
Serve as the CMC 3 SME for assigned products and be accountable for the delivery of all regulatory milestones for assigned products through the product lifecycle.
Manage development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, identification of global regulatory requirements and critical evaluation of supporting documentation to confirm acceptability and identification of potential risks.
Execute regulatory strategies by leading the development, authoring and review of CMC submission components and documentation to support post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
Provide regulatory leadership as needed to product in-license/due diligence review, product divestment and product withdrawal.
Collaborate with MMD and external partners to support compliant execution of change management and conduct all activities with an unwavering focus on regulatory conformance.
Manage execution of CMC documentation including post-approval supplements, annual reports, registration renewals and responses to health authority questions per established business processes and systems.
Demonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure approval and Product supply continuity.
Assess and communicate potential regulatory risks and propose mitigation strategies.
Deliver all regulatory milestones for assigned products across the product lifecycle
Identify, communicate and escalate potential regulatory issues to GRACS CMC management, as needed
Required Qualifications:
Strong experience in CMC requirements for small molecule/biologic products.
Proven experience in critically reviewing detailed scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
Demonstrated superior oral and written communication skills in multicultural settings and ability to communicate complex issues in a succinct and logical manner. Strong listening skills.
Demonstrated sound understanding of related fields (e.g., manufacturing, analytical, quality assurance) and the ability to be creative and imaginative in the approach to new and diverse problem solving.
Demonstrated ability to generate innovative solutions to complex regulatory problems and effectively work with and communicate to key stakeholders.
Demonstrated flexibility in responding to changing priorities or dealing with unexpected events.
Demonstrated effective leadership, communication, interpersonal and negotiating skills.
Ability to mentor a team of direct or matrixed colleagues to deliver on business commitments and project timelines.
Must be able to travel occasionally globally.
Educations:
Bachelor's degree required in science, engineering or related field (advanced degree preferred)
Experience:
At least seven (7) years of relevant experience, including research; manufacturing, testing, or licensure of pharmaceutical, vaccine, or biological products; or related fields.
Please provide current and desired salary requirements.
Job Type: Full-time
Job Location:
Short Hills, NJ
Required education:
Bachelor's

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