Regulatory Project Head – Biosimilar
Year Mumbai, Maharashtra, India
Job Description
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Primary Job Function: (CMC and Non CMC) Independently working under limited supervision to provide strategic and operational regulatory direction & support to global regulatory affairs (GRDS & CMC) : Product registrations /Submissions
- Leads one or more biosimilar/biotech projects, compile, and prepare high quality regulatory documentation for complex global regulatory submission worldwide.
- Prepare, execute, and implement the global regulatory strategy for new biosimilar / biotech product introduction and life cycle maintenance (CMC and non-CMC)
- To ensure timely submission and approval according to plan and commitment for new submission and post approval changes.
- Provide regulatory direction on global regulatory requirements to support product registration various business deals.
- Leads x-fct strategy and preparation for scientific advice for assigned biosimilars / biotech products incl preparation of briefing book and coordination with affiliate and SMEs for respective meetings.
- Leads and coordinates regulatory due diligence activities for assigned biosimilar/ biotech projects.
- Be the lead member from global regulatory on behalf of regional and national regulatory function in project team and represent global regulatory affairs function
- Lead the preparation of variation packages & queries responses to various health authorities and may interact directly with regulatory authorities or external parties.
- Ensure all filings are maintained per regulatory requirements and consistent with biosimilar strategy throughout development and product life cycle according to the plan.
- Ensure and lead regulatory compliance for assigned biosimilar / biotech products across all EPD markets
- Review and assess impact of regulation changes, new regulation and competitive intelligence and translate it into impact and mitigation strategies / opportunities for EPD biosimilar / biotech products decisions for Abbott biosimilar products.
- Generate and communicate biosimilar intelligence to bring awareness and refine actively identify and lead strategic external engagement to shape the external RA landscape for biosimilars / biotech products in EPD markets
- Partner with regulatory team at global and affiliate level to build, align, communicate, and execute regulatory strategies, according to timelines and priorities communicate.
- Identify process needs to meet internal & external challenges
- Escalate regulatory issues, progress, and metrics to functional head
- Comprehensive understanding of global regulatory landscape for biosimilar/ biotech products
- Regulatory experience with biosimilar development & product filings
- Team skills, especially in working with internal and external partners and performing due diligence
- Familiarity with project management requirements
- Ability to influence, understand and communicate scientific CMC and non-CMC information
- Anticipate and prevent potential issues
- Develops scenario and contingency plans that ensure achievement for results under changing conditions and situations
- Proactively implements change to mitigate risks, solve issues or improve processes and ways of working.
- Actively gathers customer inputs in order to anticipate and fulfill their needs and requirements
- Manages internal/external stakeholders to identify and address issues
- Understands the situation or audience and adjusts approach to achieve desired outcomes
- Effectively prioritizes and plans long-term (months/years) work tasks and projects, including the work of others
- Has \xe2\x80\x9cbig picture\xe2\x80\x9d thinking to Identify synergies and opportunities across the organisation
- Regularly reviews commitments and re-prioritises activities or negotiates timelines as necessary
- Reacts quickly to solve problems and issues as they arise
- Provides guidance, advice and mentoring to colleagues
- Understands the organisation and the roles of other functions
- Proactively anticipates, mitigates and avoids problems and issues
- Proactively seeks feedback from manager and team members and adapts behaviour to improve performance
- Maintains strong customer focus.
- Uses intrapreneurial skills to identify and execute new or unique ways to address work problems and opportunities
- Creates an environment of experimentation and uses failure as an opportunity to learn and take alternate action
- Challenges current thinking and generates new ideas. Encourages others to do the same
- Integrates information from multiple sources to generate unique insights or new solutions that increase competitiveness
- Leverages diversity of people and thinking to create a competitive advantage
- Collaborates across boundaries to create cross-business opportunities
- Delivers high quality results
- Meets agreed deadlines
- Exhibits honesty and presents complete impartial information
- Displays consistency between words and actions
- Acknowledges and responds constructively to failures and mistakes
- Expresses dissatisfaction constructively, without over-reacting
- Uses leadership skills drives completion of individual and shared goals and to develop the skills of others
- Mentors junior team members
- Provides training and support on areas of subject matter expertise of Biosimilar / Biotech products.
- Provides insight, knowledge to improve functional area and build the business
- Displays energy and persistence to drive the organization forward
- Delivers what is promised; holds self and others accountable for results, commitments, and behaviors
- Takes appropriate accountability for failure; does not blame others
- Takes action in a timely manner, with urgency or caution as appropriate, but always in a planful way
- Balances short-term and long-term priorities and maximizes the opportunities for both
- Identifies crisis situations and elevates appropriately
- Openly shares information with peers and managers
- Challenges and expects to be challenged
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Job Detail
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Job IdJD3307894
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IndustryNot mentioned
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Total Positions1
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Job Type:Full Time
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Salary:Not mentioned
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Employment StatusPermanent
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Job LocationMumbai, Maharashtra, India
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EducationNot mentioned
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ExperienceYear