Abbott Pharma Regulatory Affairs Manager Vacancy – Apply Online
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Job Title: Regulatory Affairs Manager
Reporting To: GRDS Director
Eligibility Criteria:
Bachelor’s Degree in pharmacy or related subject
Experience:
Excellent oral and written communication and interpersonal skills, excellent English mandatory. Attentive to detail. 2-3 years of Regulatory experience preferred; related duration of experience in Quality, R&D, Scientific Affairs is considered.
Primary Job Functions:
- Assists the GRDS Lead as the primary EPD RA interface within the assigned Global
- Development Project Teams providing global regulatory strategic advice for assigned product(s), under supervision maintaining a relationship as a strategic partner
- Provides non-CMC global regulatory support under supervision for assigned product(s) and L&A activities, as necessary. Product-specific regulatory contact in Product Safety
- Teams (PST), Labeling Sub-teams (LST), project teams and other key supporting non-CMC functions in PV, Medical/Clinical
- Assists the GRDS lead as a primary interface within assigned Project Teams, to develop and manage global regulatory strategy with supervision ensuring appropriate input is received from functional sub-team members.
- Assists in building, maintaining and executing of 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 Labeling,
- Clinical/non-Clinical sections, RMPs, PSURs; etc, to support new filings, variations, renewals;
- Recommend & contribute to continuous process/program improvements within GRDS
- Ensures regular communication and feedback from GRDS Director
CORE COMPETENCIES
ADAPTABILITY
- 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 a path forward, and then take timely action. Perseveres when encountering adversity
INITIATIVE
- 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 the scope of projects.
- Proactively seeks feedback from manager, team members and direct reports and adapts behavior to improve performance.
- Identifies opportunities to improve efficiencies and informs the manager.
INNOVATION
- 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.
INTEGRITY
- Delivers high-quality results. Meets agreed on 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
- Open to diverse and new ideas.
- Actively gains agreement from others to support ideas.
- Helps others achieve shared goals.
LEADERSHIP COMPETENCIES
SET VISION AND STRATEGY
- Participates in the setting of strategy which aligns with an 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.
DRIVE RESULTS
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 under supervision.
- Develop and manage global regulatory strategies ensuring appropriate input is received from functional sub-team members under the supervision
- Attendance at project teams (Development Project Teams, Product Safety Teams, etc.) and Regulatory sub-team meetings, representing EPD Global RA as appropriate with supervision.
- Assists in preparing regulatory submissions and developing strategy with supervision for response to regulatory agency queries. Responsible for ensuring accuracy and quality of non-CMC documentation.
- Monitoring actual vs. planned activities/timelines, start to identify/recommend improvements to correct or accelerate project progression
- Recommend & contribute to continuous process/program improvements within GRDS
- Provides regulatory input into the content of non-CMC parts of dossiers such as Labeling, Clinical/non-Clinical sections, RMPs, PSURs; etc, to support new filings, variations, renewals\
- Provides strategic input into core CCDS and label questions.
POSITION ACCOUNTABILITY/SCOPE:
- 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 a 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
- The 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 and colleagues.
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