Abbott Regulatory Affairs Manager in Maidenhead, United Kingdom
Primary Job Function:
Serves as the primary Established Pharmaceuticals Divison (EPD) Regulatory Affairs (RA) interface within assigned Global Development Project Teams & Brand Team(s), providing global regulatory direction and leadership for assigned product(s), maintaining a relationship as a strategic partner
Provides non-CMC global regulatory support for assigned product(s) and L&A activities, as necessary. Product specific regulatory contact in Product Safety Teams (PST), Labeling Sub-teams (LST), Brand teams and other key supporting non-CMC functions in PV, Medical/Clinical
As primary interface within assigned Project Teams, develops and manages global regulatory strategy ensuring appropriate input is received from functional sub-team members.
Builds, maintains and executes non-CMC global regulatory strategies (including labeling) for assigned product(s) with input from RA sub-team members
Provide regulatory input into the content of non-CMC parts of dossiers such as Labelling, Clinical/non-Clinical sections, RMPs, PSURs; etc, to support new filings, variations, renewals;
Ensures regular communication and feedback from GRDS Director
Effectively prioritizes midterm (months) work tasks.
Works with others to develop potential alternatives when confronted with problems.
When confronted with a problem or crisis, considers alternatives, consults with others on selecting path forward, and then takes timely action. Perseveres when encountering adversity
Demonstrates a willingness to learn new aspects of the business e.g. International regulations; Clinical; device, nutrition regulations)
Continuously monitors key issues and/or trends and updates manager.
Challenges assumptions and traditional way of doing things within scope of projects.
Proactively seeks feedback from manager, team members and direct reports and adapts behaviour to improve performance.
Identifies opportunities to improve efficiencies and informs manager.
Identifies / tries different or unique ways (within own project / group) to address work problems or opportunities, and/or reduce costs.
Combines information from multiple sources to solve work problems.
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.
Open to diverse and new ideas.
Actively gains agreement from others to support ideas.
Helps others achieve shared goals.
Set Vision and Strategy
Participates in the setting of strategy which aligns with 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.
Coaches others on achievement of goals and personal development
Make Difficult Decisions
Quickly acknowledges crisis situations and takes timely corrective action.
Elevates issues and confers appropriately to resolve issues
Encourage an Open Environment and Knowledge Sharing
Provides honest, accurate feedback to managers, whether positive or negative.
Openly shares information with direct reports and peers.
Encourages brainstorming and the expression of different points of view and sharing of knowledge.
Core Job Responsibilities:
Provide strategic regulatory advice for assigned Development Programs to I&D/ Commercial counterparts.
Develop and manage global regulatory strategies ensuring appropriate input is received from functional sub-team members
Attendance at project teams (Development Project Teams, Brand teams, Product Safety Teams, etc.) and Regulatory sub-team meetings, representing EPD Global RA as appropriate.
Prepares regulatory submissions, and develops strategy for response to regulatory agency queries Responsible for ensuring accuracy and quality of non-CMC documentation.
Monitoring actual vs. planned activities/timelines, identify/recommend improvements to correct or accelerate project progression
Responsible for ensuring Core Label compliance by coordinating/managing CCDS updates (and associated label change requests) through LSTs, planning/despatching appropriate labelling variations to Affiliates in a timely manner.
Supports strategic review of competitior labels and monitors innovator labels making appropriate updates to Abbott Branded/generic product labels accordingly.
Reviews and approves promotional materials with respect to CCDS and relevant code of conduct.
Reviews PSURs/RMPs/ACOs. Works with expert functions to ensure appropriate supportive documentation is provided.
Imparts regulatory knowledge and experience to junior staff for specific projects
Effective Interface within EPD RA and broader Abbott Organization
Project or Geographic or Product Accountability
-Manage projects within one or more therapeutic areas.
-Manager provides project assignments and strategic direction
-Minimal supervision of project required
Scope of Accountability
(Budget, Resources, Planning)
-Accountable for assigned project/task scope; completion with scheduled completion date
- No direct budgetary responsibility
-Adheres to departmental guidelines on expenses
-Identifies opportunities for cost savings
-Provides estimates of activities with budgetary impact
Resolution, Prediction of regulatory issues
Anticipate future problems, resolve current issues. Learns and adjusts based on prior results.
Awareness and application of Regulatory Intelligence
Maintain awareness of new draft legislation and guidelines.
Communicate impact and relevance of new draft legislation and guidelines to project teams
Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, engineering or related subject or equivalent
Excellent oral and written communication and interpersonal skills, excellent English mandatory.
Attentive to detail.
Regulatory experience preferred; related duration of experience in Quality, R&D, Scientific Affairs is considered
An Equal Opportunity Employer
Abbot welcomes and encourages diversity in our workforce.
We provide reasonable accommodation to qualified individuals with disabilities.
To request accommodation, please call 224-667-4913 or email firstname.lastname@example.org