Regulatory Affairs Analyst
Regulatory Affairs Analyst
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Job Description
Key Responsibilities:
Products
- Provides clear and constructive Europe Region (Area) regulatory input and intelligence to Area and Global Regulatory & Development Project Teams via the Area and/or Global Regulatory Lead (GRL) in accordance with Area & Commercial objectives.
- Ensure planned drug development activities comply with Area guidelines and if they do not escalate to Manager and provide a critical analysis of the risks and issues with a remediation proposal.
- Support global product development strategy(s); outlining options for Scientific Advice/PIP/Accelarated regulatory pathways coordinating preparation of briefing packages and supporting preparation of documents for agency meetings.
- Outline options for Europe Region filing strategy (including CP MRP DCP National); identifying risks issues and solutions.
- Plan implement and conduct regulatory activities in support of lifecycle maintenance in Area. Identify compliance risks and remediation activities proactively.
- Support lifecycle maintenance activities including the review of CMC QRD PSUR and labelling submissions and approval of productrelated packaging as required to ensure regulatory compliance.
- Implement effective planning tracking archiving of activities especially with regard to submissions internal memos and key correspondence. Ensure effective planning and tracking of activities via RIM system.
People
Build strong and effective relationships with Area Affiliate & Global regulatory & cross functional colleagues to ensure Area and Affiliate RA activities are in line with regional business priorities.
Processes
- Follow core GRS policies and procedures.
- Support implementation of new processes and input into changes in processes as required.
- Responsible for the Notification of Regulatory activities and RIM system entry/data accuracy for allocated projects.
- With supervision provide forecasts and actuals and manage in line with regional requirements communicating these to Area TA Head GRL and R&D finance for assigned projects.
- Follow all approved Abbvie Area procedures and guidance.
Qualifications :
Education and Experience
- Graduate in Life Sciences in a relevant area or equivalent industry experience
- Some awareness of both pharmaceutical regulations and guidelines and national regulations within the assigned region.
- Prior relevant experience in pharmaceutical industry or Regulatory Affairs.
Essential Skills and Abilities
- Ability to plan and organise workload including managing multiple projects.
- Ability to work effectively and collaboratively across the Abbvie organisation.
- Good interpersonal and negotiation skills.
- Good communication skills both written and verbal (in English).
- Positive can do attitude.
- Willingness to travel as necessary.
Additional Information :
AbbVie is an equal opportunity employer and is committed to operating with integrity driving innovation transforming lives serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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US & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
Remote Work :
No
Employment Type :
Fulltime
Employment Type
Full-time
