Regulatory Project Head – Biosimilar

1 month ago

mumbai, India Abbott Full time

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

Regulatory Intelligence:

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

Collaboration:

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

Knowledge and Skills

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

CORE COMPETENCIES

-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 “big picture” 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

LEADERSHIP COMPETENCIES

-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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