Manager - Regulatory Affairs

Primary Job Function :

With Manager Support :-

Product registrations / SubmissionsActively leads product registrations by preparing/ requesting documentation needed for complex filingsEmploys project management skills to monitor activities and meet deadlinesPrepares registration packages for routine filingsIdentifies and collects data neededSeeks expert advice and technical support for complex filingsPrepares responses to deficiency letters Relationships & Cross Functional team workRepresents Regulatory CMC at relevant project meetings and communicates agreed RA positionMonitors and communicates actual versus planned regulatory activities and timelinesIdentifies and communicates risks and issues impacting project progression Affiliate CoordinationMaintains strong working relationships with Regional Product Leads and Affiliate colleagues Compliance across Life-CycleAssesses and approves change requests and updates files accordinglyMaintains awareness of legislation and current developments within specific area of businessWorks to assure products remain in compliance StrategyDevelops Regulatory CMC strategies for assigned products and projectsIdentifies, communicates, and mitigates Regulatory CMC risks Process ImprovementIdentifies opportunities and suggests improvementsSupports the development of position papers & work aids etc

7. Health Agency Interaction

Attends Health Agency meetings as appropriate Licensing ReviewsProvides CMC Regulatory support for due diligence activities Technical competencyHas general knowledge of technical/scientific principles and develops specific knowledge of allocated productsHas general knowledge of global and regional regulatory requirementsHas specialist regulatory knowledge of assigned country or product-class requirements

CORE COMPETENCIES

Adaptability

Effectively prioritizes mid-term (weeks) to longer-term (months) work tasksRegularly reviews commitments and re-prioritises activities or negotiates timelines as necessaryReacts quickly to solve problems and issues when they arise

Initiative

Starts to learn new aspects of the business and understand the roles of other functionsProactively anticipates, mitigates and avoids problems and issuesProactively 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 membersProvides training and support on areas of subject matter expertiseProactively 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 negativeNot afraid to challenge peers and managers and be challengedOpenly 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