Manager - Regulatory Affairs

Job description

JOB DESCRIPTION

Primary Job Function: With Manager Support:-

• Product registrations / Submissions -Actively leads product registrations by preparing/ requesting documentation needed for complex filings -Employs project management skills to monitor activities and meet deadlines -Prepares registration packages for routine filings -Identifies and collects data needed -Seeks expert advice and technical support for complex filings -Prepares responses to deficiency letters
• Relationships & Cross Functional team work -Represents Regulatory CMC at relevant project meetings and communicates agreed RA position -Monitors and communicates actual versus planned regulatory activities and timelines -Identifies and communicates risks and issues impacting project progression
• Affiliate Coordination -Maintains strong working relationships with Regional Product Leads and Affiliate colleagues
• Compliance across Life-Cycle -Assesses and approves change requests and updates files accordingly -Maintains awareness of legislation and current developments within specific area of business -Works to assure products remain in compliance
• Strategy -Develops Regulatory CMC strategies for assigned products and projects -Identifies, communicates, and mitigates Regulatory CMC risks
• Process Improvement -Identifies opportunities and suggests improvements -Supports the development of position papers & work aids etc 7 . Health Agency Interaction - Attends Health Agency meetings as appropriate 8.

Licensing Reviews -Provides CMC Regulatory support for due diligence activities 9. Technical competency -Has general knowledge of technical/scientific principles and develops specific knowledge of allocated products -Has general knowledge of global and regional regulatory requirements -Has specialist regulatory knowledge of assigned country or product-class requirements

CORE COMPETENCIES

Adaptability -Effectively prioritizes mid-term (weeks) to longer-term (months) work tasks -Regularly reviews commitments and re-prioritises activities or negotiates timelines as necessary -Reacts quickly to solve problems and issues when they arise Initiative -Starts to learn new aspects of the business and understand 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 Innovation -Has an intrapreneurial mindset to identify new or unique ways to address work problems or 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 -Actively interacts with colleagues to drive completion of team and shared goals LEADERSHIP

COMPETENCIES

Set Vision and Strategy -Clearly articulates Regulatory CMC strategies and obtains alignment and agreement from key stakeholders Build Organization and Inspire People -Mentors junior team members -Provides training and support on areas of subject matter expertise -Proactively strengthens own leadership skills and actively uses these skills in day to day work

Drive Results -Encourages others to complete goals Make Difficult Decisions -Interacts with cross-functional and department colleagues to help drive efficient decision-making Encourage an Open Environment and Knowledge Sharing -Provides honest, accurate feedback to managers, whether positive or negative -Not afraid to challenge peers and managers and be challenged -Openly shares information with peers

Minimum Education: Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject Minimum Experience/Training Required: A minimum of 10 years of experience in Regulatory Affairs, R&D, Manufacturing or related areas The base pay for this position is N/A In specific locations, the pay range may vary from the range posted.

JOB FAMILY

Regulatory Operations DIVISION: EPD Established Pharma LOCATION: India > Mumbai : BKC Building ADDITIONAL LOCATIONS: WORK SHIFT: Standard TRAVEL: Not specified MEDICAL SURVEILLANCE: Not Applicable SIGNIFICANT WORK ACTIVITIES: Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)