Job Description

1. Product registrations /Submissions -Leads and coordinates project registrations for complex filings, including new product introductions -Identifies and collects data needed, or delegates where appropriate -Seeks and evaluates expert advice and technical support where necessary -Prepares responses to deficiency letters 2. Relationships Cross Functional team work -Represents Regulatory Affairs at relevant meetings and presents agreed RA position -Provides expert advice and technical support to cross-functional colleagues -Monitors actual versus planned activities and timelines. -Proactively identifies, communicates and mitigates risks and issues impacting project progression. 3. Affiliate Coordination -Maintains strong working relationships with Regional Product leads and Affiliate colleagues -Finds ways to improve ways of working and knowledge sharing 4. Compliance across Life-Cycle -Assesses and approves change requests and ensures files are updated accordingly -Has expert knowledge of legislation and current developments across different areas of business -Acts as a subject matter expert -Manages corrective action plans and drives to completion within agreed timelines 5. Strategy -Leads and coordinates the development of regulatory product strategies for assigned products and projects -Identifies, communicates and mitigates regulatory risks 6. Process Improvement -Identifies opportunities and proactively takes steps to implement improvements -Leads the development of position papers work aids etc 7. Health Agency Interaction -Takes a leading role in preparing for and attending Health Agency meetings as appropriate -Liaises (including acting as the single point of contact if necessary) with Notified Bodies and other medical device organisations (may not be applicable to all staff) 8. Licensing Reviews -Leads and coordinates regulatory due diligence activities for assigned projects 9. Technical competency -Has expert knowledge of global regulatory requirements -Has specialist regulatory knowledge across multiple countries, region, product class requirements -Has expert knowledge across product protfolios -Ensures knowledge remains current CORE COMPETENCIES Anticipation -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 Adaptability -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 Initiative -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. Innovation -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 Integrity -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 Teamwork -Uses leadership skills drives completion of individual and shared goals and to develop the skills of others LEADERSHIP COMPETENCIES Set Vision and Strategy -Uses influencing and negotiation skills to drive strategic alignment of key cross-functional stakeholders -Drives the generation of robust regulatory strategies for complex global projects Build Organization and Inspire People -Mentors junior team members -Provides training and support on areas of subject matter expertise -Demonstrates strong leadership skills every day and encourages the same others to do the same -Provides insight, knowledge and leadership to improve functional area and build the business Drive Results -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 -Addresses organizational or cultural barriers that could prevent success Make Difficult Decisions -Identifies crisis situations and elevates appropriately Encourage an Open Environment and Knowledge Sharing -Provides accurate, frequent and constructive feedback to subordinates, peers and leaders -Openly shares information with peers and managers -Challenges and expects to be challenged Supervisory/Management Responsibilities: Direct Reports : None (individual contributor) Indirect Reports: None (individual contributor) Minimum Education: Bachelors Degree in pharmacy, biology, chemistry, pharmacology, or related subject Minimum Experience/Training Required: 10+ years experience in Regulatory Affairs, RD, Manufacturing or related area. By exception, less experience is acceptable, e.g. if supplemented by other relevant knowledge such as a higher degree in a related discipline. JOB FAMILY: Regulatory Operations LOCATION: India > Mumbai : BKC Building t SIGNIFICANT WORK ACTIVITIES: Keyboard use (greater or equal to 50% of the workday)