Job title: Lead Consultant – Reg. Affairs
Job description: With a startup spirit and 90,000+ curious and courageous minds, we have the expertise to go deep with the world’s biggest brands—and we have fun doing it. Now, we’re calling all you rule-breakers and risk-takers who see the world differently and are bold enough to reinvent it.
Transformation happens here. Come, be a part of our exciting journey!
Are you the one we are looking for?
Inviting applications for the role of Assistant Manager, Regulatory Affairs for Consumer CMC for Global Markets and End to End Lifecycle Management for Pharma CMC for US Market.
- Responsible for implementing CMC regulatory strategies for assigned pharmaceutical/ consumer products per global regulations, guidances, and defined regulatory strategies.
- Responsible for the writing of CMC quality documents for the dossier and/or the entire module 3 from raw data.
- Review and evaluation of existing quality documentation and assessment of required updates during Project Renewals.
- Strategic regulatory intelligence during product development of new formulations (IND and NDA filings);
- Preparing the quality section of Investigational Medicinal Product Dossiers(IMPD);
- Evaluation of updates and submission of relevant sections pertaining to Active Substance Master Files (ASMF)/ Drug Master Files (DMF)
- Preparation of Quality Overall Summaries (QOS);
- Compilation of dossiers for launch applications for marketing authorization and new drug applications in Global markets
- Submission of relevant sections in Annual Reports for US Market
- Preparing RA expert response for deficiency letters from various regulatory authorities
- Assessment of registration documentation for consumer products as per the current Health Authority requirements
E2E PHARMA CMC:
- Responsible for providing regulatory support for tracking regulatory submission documents.
- To conduct regulatory intelligence in strategic discussions with other project stakeholders.
- Collaborative quality regulatory contribution to ensure quality compliant and timely submitted dossiers.
- To identify, categorize the post-approval changes, planning and assessment of impact of the change on the products.
- Responsible for handling CMC post-approval lifecycle maintenance and change management activities such as variations, renewals baselining vast range of pharma product portfolios for Global Markets.
- Expertise in post-approval guidelines and governing regulations along with dossier preparation in CTD modules and their timely submission.
- Efficient to prepare justifications for any proposed changes and respective update in the dossier.
- Knowledge of review and assessment of manufacturing, analytical, validation and stability documents.
- Act as a point of contact and communicate and follow up regarding submission status with concerned departments.
- Create and maintain comprehensive quality documentation.
- Ensure adherence to the specific project specifications or standards throughout the lifecycle of the submission
- Effective time management and organizational skills to efficiently manage multiple time-sensitive assignments simultaneously
- Demonstrates a deep understanding of the business value of quality and compliance, and the implications and risks of non-compliance. Adjusts behaviors to drive high-quality deliverables
- Demonstrates the ability to independently solve troubleshoot problems that arise within job responsibilities and expectations, and takes a new perspective using existing solutions
- Effectively communicates difficult issues both verbally and in writing to build alignment around a complex situation and process.
- Flexibility to adapt to a changing environment, keeping current with new and updated processes and procedures
Qualifications we seek in you!
- Relevant experience in regulatory affairs with must expertise and profound experience in regulatory affairs for Pharmaceutical or Biotech industry, publishing and/or lifecycle document management
- Experience in reviewing scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data
- Should be good in technical writing of CMC.
- Must demonstrate oral and written communication skills and the ability to communicate issues succinctly and logically
- Must demonstrate understanding of related fields (e.g., pharmaceutical manufacturing, analytical testing, and quality assurance).
- Ability to generate innovative solutions to problems and effectively work with and communicate with key stakeholders
- Flexibility in responding to changing priorities or dealing with unexpected events
- Capability to handle multiple priorities and balance work to achieve business goals
- Effective leadership, communication, and interpersonal skills
- Ability to prioritize tasks to meet deadlines and work with a team when help is needed
- Ability to identify problems and work with team to formulate a potential course of action
Genpact is an Equal Opportunity Employer and considers applicants for all positions without regard to race, color, religion or belief, sex, age, national origin, citizenship status, marital status, military/veteran status, genetic information, sexual orientation, gender identity, physical or mental disability or any other characteristic protected by applicable laws. Genpact is committed to creating a dynamic work environment that values diversity and inclusion, respect and integrity, customer focus, and innovation. For more information, visit www.genpact.com. Follow us on Twitter, Facebook, LinkedIn, and YouTube.
Location: Mumbai, Maharashtra
Job date: Sat, 08 Jan 2022 05:07:31 GMT
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