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About Abbott Established Pharmaceuticals
We are committed to bringing the benefits of our trusted medicines to more people in the world’s fastest-growing countries. Our broad portfolio of high-quality and differentiated branded generic medicines reaches across multiple therapeutic areas including gastroenterology, women's health, cardiometabolic, pain management/central nervous system, and respiratory.
What will you do as a Manager Regulatory Affairs?
As Manager Regulatory Affairs, your primary job consists of 5 core tasks.
Product registrations /Submissions
Proactively 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 regulatoy requirements
Defines regulatory strategies to ensure RPT submissions and competitive speed to market approvals
Manages the preparation of registration packages and answers to deficiency letters
Ensures records of filings and approvals are maintained according to internal and external standards and requirements and throughout product lifecycle
Approves the complete regulatory data packages prior to filing and during the approval process
Prepares agency meeting packages, and develops strategies for agency meetings
Relationships & Cross Functional teamwork
Represents Regulatory Affairs at relevant meetings, e.g., Product Workstream, CMC Workstream, presents agreed RA position and negotiates with and influences management (Manufacturing, Quality, Development, Commercial etc.) to ensure programs meet regulatory requirements and business needs Plans and ensures execution according to planned activities and timelines.
Identify, resolves and / or escalate issues impacting project progression for resolution and mitigation
Participates in agency meetings as appropriate
Trains, develops and mentors individuals
Maintains proactive awareness of regulatory legislation and assesses its global impact on business and product portfolio
Maintains working relationships with defined countries and provides support
Aligns on regulatoy commitments, milestones and objectives / priorities translated into regulatory strategies (regulatory strategy plans and updates)
Facilitates policy development and standard interpretation of regulations
Provide regulatory expertise to licensing departments
Identifies and implements process improvements
Identifies opportunities for business and efficiency improvements
What kind of knowledge and experience do you bring with you?
You have a Bachelor's Degree in pharmacy, biology, chemistry, pharmacology, or related subject A relevant master's degree is preferred
You have 7 years of work experience within the field; ideally includes 3 years in Regulatory You have a practical and pragmatic attitude;
You are critical and pro-active in your actions:
You have good analytical skills;
You are strong in commination and like to work in a team;
You master the Dutch language and English language in speaking and writing.
Follow your career aspirations to Abbott for diverse opportunities with a company that can help you build your future and live your best life. Abbott is an Equal Opportunity Employer, committed to employee diversity.
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