Senior Director Regulatory Affairs

2 weeks ago

United Kingdom Vector Full time

Senior Director of Regulatory Affairs – UK remote


Are you an expert within the European Regulatory Pharmaceutical Markets? Have you got experience leading successful approvals of MAA’s from the EMA?


We are proud to partner with a global market leading biotech who have developed a state-of-the-art technology platform. They have technologies at clinical trials ongoing through to Phase 3.


We are looking for a Senior Director of Regulatory Affairs, who will report into the senior leadership team and play a key role for the company strategy & direction by acting as their primary liaison to the EMEA, and wider EEA.


You will be integrating existing and emerging projects in clinical development, within the wider European market as these go through clinical trials. Due to the nature of this role, we are looking for someone situated within the UK, and the role will be remote, with occasional travel into the US and EU.



In this role you will be:

  • Planning, and executing strategies regulatory strategy across the EU/ EEA for products at all stages of development.
  • Acting as the primary liaison to the EU / EEA for the companies forthcoming products, and projects.
  • Responsible and accountable for leading MAA or CMA submission effort across all necessary functions.
  • Provide strong oversight and management of vendors and CROs as it relates to the Regulatory function and in coordination with appropriate clinical team members.
  • Monitor and interpret EU and other European countries’ relevant policies and guidance, assess the impact on company’s business, and partner with the Chief Regulatory Officer to define or refine strategies based on new guidance or policies.
  • Function as the expert internally for regulatory requirements in European regions for product development.



To be successful in this role you will need to have:

  • A master’s degree within a related Life Sciences field, ideally you will also have a PhD in a related field. We will also consider candidates with a sufficient level of experience.
  • Extensive experience at director level or higher within Regulatory Affairs.
  • Proficient experience of working within Pharmaceutical European Regulatory Markets.
  • Demonstratable experience of leading successful submissions & approvals of MAA’s from the EMA.
  • Direct experience leading formal meetings with the EMA & wider EEA health authorities.
  • Ideally, have recent experience within biologics in a RA capacity.


You will be joining a company making a significant leap forward, and one dedicated to equality & diversity at the forefront of their culture.


If you are interested in this role, or would like more information, please contact:

amelia@vectorpartnersta.com

  • Senior Director Regulatory Affairs

    2 weeks ago

    United Kingdom Vector Full time

    Senior Director of Regulatory Affairs – UK remote Are you an expert within the European Regulatory Pharmaceutical Markets? Have you got experience leading successful approvals of MAA’s from the EMA? We are proud to partner with a global market leading biotech who have developed a state-of-the-art technology platform. They have technologies at clinical...

  • Senior Director Regulatory Affairs

    2 weeks ago

    United Kingdom Vector Full time

    Senior Director of Regulatory Affairs – UK remote Are you an expert within the European Regulatory Pharmaceutical Markets? Have you got experience leading successful approvals of MAA’s from the EMA? We are proud to partner with a global market leading biotech who have developed a state-of-the-art technology platform. They have technologies at...

  • Senior Director Regulatory Affairs

    2 weeks ago

    United Kingdom Vector Full time

    Senior Director of Regulatory Affairs – UK remote Are you an expert within the European Regulatory Pharmaceutical Markets? Have you got experience leading successful approvals of MAA’s from the EMA? We are proud to partner with a global market leading biotech who have developed a state-of-the-art technology platform. They have technologies at clinical...

  • Senior Regulatory Affairs Specialist

    1 day ago

    United Kingdom Mosaic Regulatory Solutions Full time

    This global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...

  • Senior Regulatory Affairs Specialist

    2 weeks ago

    United Kingdom Mosaic Regulatory Solutions Full time

    This global manufacturer is looking for a truly talented regulatory specialist with 5 years of regulatory experience. The company is seeking a Senior Regulatory Affairs Specialist to join their collaborative and friendly team working on MENA region submissions. The company values people and offers a true career development path with on-site and external...

  • Director / Associate Director Regulatory Affairs

    2 weeks ago

    United Kingdom Meet Recruitment Limited Full time €80,000 - €120,000

    Director / Associate Director Regulatory Affairs 2 days ago Be among the first 25 applicants My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join...

  • Director / Associate Director Regulatory Affairs

    4 weeks ago

    United Kingdom Meet Recruitment Limited Full time

    Director / Associate Director Regulatory Affairs 2 days ago Be among the first 25 applicants My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join...

  • (Senior) Director Regulatory Affairs CMC

    2 days ago

    United Kingdom Autolus Ltd Full time

    Vacancy for (Senior) Director Regulatory Affairs CMC Location: United Kingdom Job Summary Role Summary An exciting opportunity has arisen for an experienced CMC Regulatory Affairs Sr. Director to join the Autolus team to take a leadership role for developing global CMC regulatory strategies and content plans for products across Autolus’ cell and gene...

  • (Senior) Director Regulatory Affairs CMC

    4 weeks ago

    United Kingdom Autolus Ltd Full time

    Vacancy for (Senior) Director Regulatory Affairs CMC Location: United Kingdom Job Summary Role Summary An exciting opportunity has arisen for an experienced CMC Regulatory Affairs Sr. Director to join the Autolus team to take a leadership role for developing global CMC regulatory strategies and content plans for products across Autolus’ cell and gene...

  • Director / Associate Director Regulatory Affairs

    4 weeks ago

    United Kingdom Meet Full time

    Associate Director (Regulatory Affairs) My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory Affairs....

  • Director / Associate Director Regulatory Affairs

    4 weeks ago

    United Kingdom Meet Full time

    Associate Director (Regulatory Affairs) My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory Affairs....

  • Director / Associate Director Regulatory Affairs

    4 weeks ago

    United Kingdom Meet Full time

    Associate Director (Regulatory Affairs)My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory...

  • Director / Associate Director Regulatory Affairs

    4 weeks ago

    United Kingdom Meet Full time

    Associate Director (Regulatory Affairs)My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory...

  • Director / Associate Director Regulatory Affairs

    4 weeks ago

    United Kingdom Meet Full time

    Associate Director (Regulatory Affairs) My client are a dynamic and innovative medical technology company focused on developing advanced healthcare solutions. As we navigate through the transition to the Medical Device Regulation (MDR), we are seeking a highly skilled and experienced professional to join our team as Associate Director of Regulatory Affairs....

  • Senior Director/ Executive Director Regulatory Affairs Lead

    1 day ago

    United Kingdom Autolus Ltd Full time

    Vacancy for Senior Director/ Executive Director Regulatory Affairs Lead - Autoimmune Location: UK/EU/US Job Summary Role Summary With a significantly expanding regulatory team, an exciting opportunity has arisen for an experienced Global Regulatory Affairs Lead (Senior Director/Executive Director) for AutoImmune to join the Autolus team to expand their...

  • Senior Director/ Executive Director Regulatory Affairs Lead

    4 weeks ago

    United Kingdom Autolus Ltd Full time

    Vacancy for Senior Director/ Executive Director Regulatory Affairs Lead - Autoimmune Location: UK/EU/US Job Summary Role Summary With a significantly expanding regulatory team, an exciting opportunity has arisen for an experienced Global Regulatory Affairs Lead (Senior Director/Executive Director) for AutoImmune to join the Autolus team to expand their...

  • Senior Regulatory Affairs Manager

    2 days ago

    United Kingdom RApport Strategic Services Limited Full time €75,000 - €100,000

    Location: Surrey/Remote A specialist international regulatory consultancy, bringing cutting-edge and life-changing medicines and medical devices to global markets. The RApport-ELIQUENT team continues to grow from strength to strength, with the team applying our latest thinking in creating the next generation of regulatory solutions that deliver value to...

  • Senior Manager/Director of Regulatory Affairs

    1 week ago

    United Kingdom Park Street People Full time

    A global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team. You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide...

  • Senior Manager/Director of Regulatory Affairs

    1 week ago

    United Kingdom Park Street People Full time

    A global pharmaceutical company, based in Uxbridge is currently looking for a Senior Regulatory Affairs Manager to join their team. You will be a confident Regulatory Lead looking to work in an innovative therapy area, developing and defining regulatory plans across multiple products. This is a great opportunity to work with a team who take provide...

  • Senior Director Regulatory Affairs

    3 days ago

    United Kingdom Transcrip Partners Full time

    Customize Consent Preferences Always Active cookieyes-consent Duration 1 year Description __cf_bm Duration 30 minutes Description _ga_* Duration 1 year 1 month 4 days Description _ga Duration 1 year 1 month 4 days Description vuid Duration 1 year 1 month 4 days Description CONSENT Duration 2 years Description YSC Duration session...