Regulatory Affairs Manager
Regulatory Affairs Manager
Posted on :
15-03-2025
Employer Active
1 Vacancy
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Monthly Salary
Not Disclosed
Salary Not Disclosed
Vacancy
1 Vacancy
Posted on :
15-03-2025
Job Description
Job Title: Regulatory Affairs Manager
Job Location: Maidenhead SL6 UK
Job Location Type: Onsite
Job Contract Type: Fulltime
Job Seniority Level: MidSenior level
Company Description
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology oncology neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie please visit us at www.abbvie. Follow @abbvie on X Facebook Instagram YouTube LinkedIn and Tik Tok.
Job Description
In collaboration with line manager and/or Area Product Lead is responsible for implementation of registration strategy to ensure the regulatory approval of commercially successful pharma products in the Europe region. Is responsible for ensuring effective product maintenance and lifecycle management in line with legal/regulatory requirements and regional business needs. May also support European regulatory strategy for assets in development.
Highlighted responsibilities:
Products
In consultation with line manager and/or Area Product Lead;
Qualifications & experience:
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 AbbVie’s 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.
US & Puerto Rico only to learn more visit https://www.abbvie/joinus/equalemploymentopportunityemployer.html
US & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
https://www.abbvie/joinus/reasonableaccommodations.html
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas – immunology oncology neuroscience and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie please visit us at www.abbvie. Follow @abbvie on X Facebook Instagram YouTube LinkedIn and Tik Tok.
Job Description
In collaboration with line manager and/or Area Product Lead is responsible for implementation of registration strategy to ensure the regulatory approval of commercially successful pharma products in the Europe region. Is responsible for ensuring effective product maintenance and lifecycle management in line with legal/regulatory requirements and regional business needs. May also support European regulatory strategy for assets in development.
Highlighted responsibilities:
Products
In consultation with line manager and/or Area Product Lead;
- 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 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/IMPD coordinating preparation of briefing packages and coordinating and leading agency meeting preparation.
- Prepare strategy recommendations to global regulatory and development teams in order to shape the global product strategy in line with Area regulatory and commercial objectives
- Define & implement Area filing strategy (including CP MRP DCP); identifying risks and proposing mitigation.
- Lead plan conduct and implement regulatory activities in support of lifecycle maintenance in Area. Identify compliance risks and remediation activities proactively.
- GRPT & ARPT representative ensuring regulatory requirements/interests of Area & Affiliate are represented at GRPT
- Supports coordination of the review of CMC QRD PSUR and labelling submissions and approval of productrelated packaging as required to ensure regulatory compliance.
- Interface with EMA or Area Health Authority(s) for products within the Therapeutic Area on behalf of the Product Lead when required.
- Responsible for ensuring effective planning and tracking of activities especially submissions and key correspondence. Ensures effective planning and tracking of activities via internal tools
- Supports coordination of the review of CMC QRD PSUR and labelling submissions and approval of productrelated packaging as required to ensure regulatory compliance.
- Establishes strong and effective relationships with affiliates area and global regulatory teams as well as crossfunctional teams thereby ensuring RA activities are in line with regional business priorities.
- Potential to mentor less experienced Area regulatory colleagues as required
- Follows Global Regulatory policies and procedures.
- Ensures that new processes are developed and implemented in order to leverage the global infrastructure and maximise efficiency ensures that new processes are aligned with global policies but also meet regional regulations and needs.
- Responsible for the Notification of Regulatory activities and RIM system entry/data accuracy for allocated projects.
- Responsible for ensuring forecasts are developed and actuals managed in line with regional requirements and communicating these to Area TA Head GRL and R&D finance for assigned projects.
Qualifications & experience:
- Graduate in Life Sciences in a relevant area.
- Sound knowledge of both pharmaceutical regulations and guidelines and national regulations within Area.
- Pharmaceutical industry experience in European Regulatory strategy development and regulatory procedures EU centralised procedure essential. Experience of EU strategy for development assets e.g. scientific advice paediatric investigation plans preferred.
- Experience working effectively across cultures and in complex matrixed environment.
- Excellent organizational skills and solution driven leadership style
- Ability to prioritise and manage workload including managing multiple projects.
- Ability to work effectively and collaboratively across the Abbvie organisation.
- Experienced in working effectively across cultures and in complex matrix environment.
- Good interpersonal and negotiation skills and the ability to influence others.
- Travel approximately 10
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 AbbVie’s 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.
US & Puerto Rico only to learn more visit https://www.abbvie/joinus/equalemploymentopportunityemployer.html
US & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
https://www.abbvie/joinus/reasonableaccommodations.html
https://lifelancer/jobs/view/8bcccdf51f65f158fede815
Employment Type
Full Time
Key Skills
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