Director, Regulatory Affairs EU

2 weeks ago

Dublin, Dublin City, Ireland Emergent BioSolutions Full time
Select how often (in days) to receive an alert:

Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed to protect life.

JOB SUMMARY

The Director, Regulatory Affairs will oversee regulatory activities across Emergent's product portfolio. The Director Regulatory Affairs is responsible for providing strategic direction to the business and other stakeholder functions as it pertains to EU & global licensure of Emergent products. The Director is responsible for leading the development and implementation of RA strategies and establishing optimal regulatory positions for all of Emergent's product portfolio and maintaining the licenses of existing commercial products.

ESSENTIAL FUNCTIONS

Reasonable accommodations will be made to enable individuals with disabilities to perform the essential functions.

1. Directs and develops regulatory group located across Emergent sites or remotely located
2. Develop and lead regulatory strategy, for the EU and global, for Emergent products
3. Provide regulatory guidance to cross-functional groups regarding all aspects of manufacturing, quality, preclinical and clinical development and testing for products with a focus on EU and/or UK requirements
4. Directs efforts for planning and execution of required regulatory filings
5. Works with project teams to resolve complex project issues. Utilizes regulatory expertise and knowledge of regulatory requirements and regulations to strategically interpret, plan, and communicate requirements to ensure governmental approvals are obtained.
6. Prepare company team for EMA or and other health authority meetings
7. Serve as Regulatory Liaison to the EMA, MHRA, or local Member State Health Authorities in the EU (and other regulatory authorities) for assigned projects
8. Represent Regulatory Affairs at cross-functional teams core teams
9. Manage preparation and communicate regulatory risk assessment to core team, business unit team and senior management; propose mitigation approaches
10. Provide critical review of documentation supporting regulatory applications including, but not limited to, pre-IMPD and formal meetings with health authorities, IMPDs, Clinical Trial Applications, Annual Reports, BLAs, NDAs, MAAs, Variations and BLA supplements
11. Ensure RA activities are aligned Project timelines & business objectives and are in compliance with ICH, FDA, HC, UK, and EU regulations
12. Maintain knowledge of regulatory environment, regulations and guidance's.
13. Interact with company partners and consultants for various regulatory matters as needed
14. Contribute regulatory perspective as needed on government proposals and external due diligence activities
15. Contribute to the modification, development and implementation of company policies and procedures for regulatory affairs
16. Responsible for department budget

The above statements are intended to describe the nature of work performed by those in this job and are not an exhaustive list of all duties. Nothing in this job description restricts managements right to assign or reassign duties and responsibilities to this job at any time which reflects management's assignment of essential functions.

MINIMUM EDUCATION, EXPERIENCE, SKILLS

1. B.Sc. degree in related biological and life sciences field (M.Sc. or Ph.D. preferred)
2. 12+ years directly related experience in Regulatory Affairs, in biotechnology or pharmaceutical industry.
3. Knowledge of EU and global regulations / guidance's and thorough knowledge of biological/ drug development process required.
4. Strong strategic and critical thinking, diplomacy, negotiation and excellent oral and written communications skills.
5. Strong decision-making abilities
6. Ability to understand and apply technical materials and regulations, strong technical writing skills, knowledge of CMC, clinical and non-clinical pharmaceutical development,
7. Possess a broad knowledge of biopharmaceutical manufacturing and operations.
8. Demonstrated people-leader skills and evaluation of performance.

There are physical/mental demands and work environment characteristics that must be met by an individual to successfully perform the essential functions of the job. This information is available upon request from the candidate.

As part of our team, you'll join talented and inspiring colleagues whose sense of purpose complements your own. We offer highly diverse career opportunities, a supportive culture, competitive salaries, flexible work arrangements and an extensive benefits package. Information submitted will be used by Emergent BioSolutions for activities related to your prospective employment. Emergent BioSolutions respects your privacy and any use of the information submitted will be subject to the terms of our Privacy Policy.

ABOUT EMERGENT

Protecting and Enhancing 1 billion lives by 2030 focuses our energy to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.

Our drive towards this vision informs all of our actions—whether it is our approach to product development, manufacturing, encouraging employee health and wellness or giving back to the community—we strive every day to achieve this shared goal.

WE BELIEVE IN OUR VALUES

- Lead with Integrity

- We gain trust and confidence through ethics, quality, and compliance excellence

- Stand shoulder to shoulder no matter what

- We combine our best thinking and communicate openly to support each other.

- Own it always

- Every person at Emergent is engaged and accountable for delivering on our commitments.

- Break through thinking

- We take smart risks, pursue innovation and challenge ourselves to constantly improve.

- Compete where it counts

- We set the right goals and respect each other as we conquer them together.

#J-18808-Ljbffr

  • Director, Regulatory Affairs EU

    2 weeks ago

    Dublin, Dublin City, Ireland Emergent Biosolutions Full time

    Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products designed-to protect life. JOB SUMMARY The Director,...

  • Director, Regulatory Affairs EU

    3 weeks ago

    Dublin, Dublin City, Ireland Emergent BioSolutions Full time

    Select how often (in days) to receive an alert:Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products...

  • Director, Regulatory Affairs EU

    5 days ago

    Dublin, Dublin City, Ireland Emergent BioSolutions Full time

    Select how often (in days) to receive an alert:Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products...

  • Director, Regulatory Affairs EU

    1 week ago

    Dublin, Dublin City, Ireland Emergent BioSolutions Full time

    Select how often (in days) to receive an alert:Those who join Emergent BioSolutions feel a sense of ownership about their future. You will excel in an environment characterized by respect, innovation and growth opportunities. Here, you will join passionate professionals who advance their scientific, technical and professional skills to develop products...

  • Regulatory Affairs Director

    2 days ago

    Dublin, Dublin City, Ireland Emergent Biosolutions Full time

    **About the Role**We are seeking a highly experienced Regulatory Affairs Director to lead our EU regulatory strategy and ensure compliance with global regulations.The successful candidate will have a strong understanding of the EU regulatory environment and be able to develop and implement effective strategies to obtain and maintain product licenses.Key...

  • Regulatory Affairs Director

    19 hours ago

    Dublin, Dublin City, Ireland Emergent Biosolutions Full time

    Company Overview:Emergent BioSolutions is a leading biotechnology company that aims to protect and enhance 1 billion lives by 2030. We strive to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.We believe in our values of Lead with Integrity, Stand shoulder to shoulder no matter...

  • Director of EU Regulatory Compliance

    15 hours ago

    Dublin, Dublin City, Ireland Emergent Biosolutions Full time

    About Us:Emergent BioSolutions is dedicated to protecting and enhancing 1 billion lives by 2030. We strive to improve the quality of life for individuals around the world, giving them the opportunity to experience the fullness of life.Our team believes in the importance of integrity, teamwork, accountability, innovation, and respect. These values guide our...

  • Director Regulatory Affairs

    3 weeks ago

    Dublin, Dublin City, Ireland The RFT Group Full time

    Job Description Senior Director Device Regulatory Affairs This is a rare opportunity to join a young, exciting clinical-stage biotechnology company. Our client is focused on the discovery and development of novel therapies, with the potential to fundamentally change the course of progressive, debilitating diseases. 2023 has been a year of highly...

  • Regulatory Affairs Director

    1 day ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Cpl Healthcare is a multinational medical device and health care company seeking a Regulatory Affairs Manager to lead its Regulatory Affairs Sub-Function. The successful candidate will be responsible for managing teams and overseeing the strategy implementation and operations for directing development of product registration submission, progress reports,...

  • EU Regulatory Compliance Lead

    1 day ago

    Dublin, Dublin City, Ireland Emergent Biosolutions Full time

    **EU Regulatory Compliance Lead**We are seeking a highly experienced Regulatory Affairs Director to lead our EU regulatory compliance efforts and ensure compliance with global regulations.The successful candidate will have a strong understanding of the EU regulatory environment and be able to develop and implement effective strategies to obtain and maintain...

  • Regulatory Affairs Director

    16 hours ago

    Dublin, Dublin City, Ireland Brightwater Full time

    About the DepartmentThe Veterinary Sciences (VS) department of the Health Products Regulatory Authority (HPRA) is responsible for regulating and monitoring the safety, quality, and efficacy of veterinary medicines and animal health products in Ireland.About the PositionWe are seeking a highly skilled and experienced professional to join our team as Director...

  • Senior Regulatory Affairs Specialist

    1 week ago

    Dublin, Dublin City, Ireland Life Science Recruitment Full time

    Senior Regulatory Affairs SpecialistOur client a high potential medical device start up current seeks a Senior Regulatroy Affairs Specialist to join their team. Reporting to the Director of Quality and Regulatory Affairs the Senior Regulatory Affairs will take an active role in developing the Regulatory strategy in Europe and the US and interacting with the...

  • Regulatory Affairs

    1 week ago

    Dublin, Dublin City, Ireland Thornshaw Recruitment Full time

    Thornshaw Scientific, in collaboration with my client, a global pharmaceutical company, now have a new opportunity for a Regulatory Affairs Officer to join the Dublin team.Key Responsibilities:Manage EU marketing authorisation dossiers and submissions (MAAs, lifecycle activities, variations, transfer etc.) for our current portfolio of pharmaceutical...

  • Regulatory Affairs Manager

    3 days ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    JOB DESCRIPTION FORM Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin. Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities: Take lead role and responsibility for the...

  • Regulatory Affairs Officer

    3 weeks ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Thornshaw Scientific, in collaboration with my client, a global pharmaceutical company, now has a new opportunity for a Regulatory Affairs Officer to join the Dublin team. The same company also has Senior Regulatory Affairs Officer opportunities.Key Responsibilities:1. Manage EU marketing authorisation dossiers and submissions (MAAs, lifecycle activities,...

  • Regulatory Affairs Manager

    1 week ago

    Dublin, Dublin City, Ireland Thornshaw Recruitment Full time

    Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin.Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities:To take lead role and responsibility for the effective planning,...

  • Regulatory Affairs Manager

    1 week ago

    Dublin, Dublin City, Ireland Thornshaw Recruitment Full time

    Thornshaw Scientific on behalf of their client, a global pharmaceutical company now have a new opportunity for a Regulatory Affairs Manager to join the team in Dublin.Reporting to the Global Regulatory Affairs Associate Director, this is a full time/hybrid position.The role & Responsibilities:To take lead role and responsibility for the effective planning,...

  • Regulatory Affairs Manager

    1 week ago

    Dublin, Dublin City, Ireland Cpl Healthcare Full time

    Regulatory Affairs ManagerMy client, a multinational medical device and health care company, is looking to recruit a Regulatory Affairs Manager. The Regulatory Affairs Manager will be in charge of managing teams within the Regulatory Affairs Sub-Function. The core focus of this position is on policy and strategy implementation and control rather than...

  • Director Advocacy And Public Affairs

    4 days ago

    Dublin, Dublin City, Ireland Insurance Ireland Full time

    Director Advocacy and Public Affairs Insurance Ireland Dublin EUR Insurance Ireland is the representative organisation for insurance in Ireland.As well as serving Irish businesses and consumers, Ireland is also a thriving global hub for insurance, reinsurance and InsurTech.Irish insurers are the number one providers of cross-border services in the European...

  • Regulatory Affairs Specialist

    1 day ago

    Dublin, Dublin City, Ireland CPL Full time

    Job DescriptionThornshaw Scientific, a division of CPL Group, collaborates with global pharmaceutical companies to offer rewarding career opportunities. As a Senior Regulatory Affairs Officer New, you will play a crucial role in ensuring compliance with EU regulations.Key Responsibilities:• Oversee the management of EU marketing authorisation dossiers and...