Manager - Regulatory Affairs

JOB DESCRIPTION:

Primary Job Function:

With Manager Support:-

1. 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

2. 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

3. Affiliate Coordination

-Maintains strong working relationships with Regional Product Leads and Affiliate colleagues

4. 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

5. Strategy

-Develops Regulatory CMC strategies for assigned products and projects

-Identifies, communicates, and mitigates Regulatory CMC risks

6. 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:

Bachelors 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)

Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.