JOB DESCRIPTION:
About Abbott
Abbott is a global healthcare leader, creating breakthrough science to improve people’s health. We’re always looking towards the future, anticipating changes in medical science and technology.
Abbott Established Pharmaceuticals (EPD) is looking for a
EM Regulatory Affairs Strategy Lead
for its global Pharma Division Headquarter based in Allschwil- Basel.
Primary Job Function:
This role would be a key role in the new centralized EM regulatory function that is being created in 2023. The incumbent of this role will bring in an ideal mix of technical skills in Clinical regulatory as well as CMC regulatory. This would be supplemented by good project management skills and ability to manage a broad cross-section of internal and external stakeholders. Based in the EM headquarters in Basel, this role would be a key nodal point for maintaining the current business and supporting the future growth.
Independently:
1. Product registrations /Submissions
- Identifies/obtains data needed, and ensures that they are effectively presented for the registration of products
- Assesses scientific data provided by specialist units for registration purposes against regulatory requirements
- Manages the preparation of registration packages (including complex) and answers to deficiency letters
- Facilitates and leads Biosimilar and Biologics submissions for the Emerging Markets business.
2. Relationships & Cross Functional team work
- Represents Regulatory Affairs at relevant meetings e.g. Brand team, Product Workstream, CMC Workstream and presents agreed RA position and negotiates with and influences management (Manufacturing, Quality, Development, Commercial etc.) to ensure programs meet regulatory requirements
- Participates in agency meetings as appropriate
- Trains, develops and mentors individuals; may include formal supervisory responsibilities
- Works with the Regulatory leaders to identify ways of simplifying/harmonizing activities across the EM region to balance the increasing workload and resource constraints
- Maintains working relationships with Affiliates Regulatory teams and provide support, forward planning, workload prioritization and performance management.
- Liaises closely with the SMEs in the India hub and provides support to the affiliates.
3. Strategy
- Advises Business Partners ( e.g. Commercial, Development, QA, Manufacturing, New Business Development) on global regulatory requirements
- Defines regulatory strategies for the products filing
- Facilitates policy development and standard interpretation of regulations
CORE COMPETENCIES
LEADERSHIP COMPETENCIES
Set Vision and Strategy
Participates in the setting of strategy aligned to organizational strategy for individual products /projects in the short term.
Communicates current and future work plans, goals, and initiatives
Build Organization and Inspire People
Maintains high energy and a positive attitude in challenging situations.
Serves as a role model for others.
Regulatory and Technical
Good knowledge of technical/scientific ICH principles within pharma (appreciation of WHO and other international guidelines).
Strong experience and expertise in filing strategies in the emerging markets
Strong knowledge and experience in CMC issues.
Proven experience with issue management from a regional/affiliate setting.
Applies scientific knowledge to issues surrounding area of responsibility.
Proactively keeps current on new scientific/technical issues in areas of responsibility.
Core Job Responsibilities:
- Provide strategic input into the development of assigned projects handling complex issues, seeking guidance where appropriate.
- Be the go-to person for commercial function to resolve regulatory issues and ensuring smooth commercialization and supply chain integrity.
- Demonstrate appropriate mix of subject matter expertise and commercial acumen to provide input into development projects and lifecycle maintenance bottlenecks.
- Ensure input from sub-team members and issue international regulatory plans as appropriate.
- Attendance at project teams (Brand teams, Product Workstreams, CMC Workstreams etc.) and sub-team meetings, representing EPD RA as appropriate.
- Prepare regulatory filings for submission to international regulatory agencies.
- Manage strategy for response to regulatory agency queries, ensuring scientific dossier content and consistency of scientific content and Company position across geographic areas.
- Coordinate assigned affiliate(s) workload planning & prioritization and performance
- Monitor actual vs. planned activities and timelines.
- Identify issues impacting project progression and work with manager to recommend improvements to correct or accelerate project progression
- Prepare and present written and oral reports and other presentations to team members and other internal audiences. Adjusts presentation style and content to suit the audience.
- Manage the preparation and review of technical strategic regulatory documentation for agency submission.
- Responsible for ensuring accuracy and quality of documentation
Minimum Education:
- Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject
- A relevant Masters Degree is preferred
Minimum Experience/Training Required:
- Minimum 10 years in Regulatory Affairs; including 5 years in the Emerging Markets
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:
Switzerland > Allschwil : H-127
ADDITIONAL LOCATIONS:
WORK SHIFT:
Standard
TRAVEL:
Yes, 10 % of the Time
MEDICAL SURVEILLANCE:
Not Applicable
SIGNIFICANT WORK ACTIVITIES:
Not Applicable
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