Global Regulatory Manager

1 month ago

Bracknell, United Kingdom Allucent Full time

At Allucent™, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.

We are looking for a Global Regulatory Manager (GRM) to join our A-team (hybrid*/remote). The Global Regulatory Manager is responsible for managing regulatory activities, developing and implementing strategies for timely (regulatory) approvals, ensuring timely preparation and submission of local, regional and global submissions to RAs/IECs/IRBs, ensuring the quality, content and format of regulatory submissions; serving as a direct point of contact for regulatory questions raised by the Sponsor, Allucent’s Senior Leadership team, Business Development, Auditors and Inspectors.

In this role your key tasks will include:

  • Contributes to the KOM if required to cover aspects related to RA/IEC/IRB submission and approval.
  • Develop Regulatory and Ethics Submission Plan (RESP)
  • Coordinate the preparation of RA/IEC/IRB submission, including amendment submissions: will work alongside the Global Start-up Manager/PM ensuring submissions are performed according to internal and client expectations.
  • Plan realistic timelines for submissions and approvals at study & country level
  • Act as a source of information for Sponsors, Senior Leadership, Global Study Start-up Managers, Pharmacovigilance, Business Development, Auditors and/or Inspectors for Regulatory Requirements in countries participating in a clinical trial
  • Represent the company in interactions with RA/IRB/IEC reviewers to pursue approvals, obtain information, and clarify issues
  • Coordinate the Site Activation Specialists, Global Submission Specialists and Global Start-Up Assistants during preparation, compilation and submission to RA/IEC/IRB until the corresponding approvals are in place
  • Review and finalize Master SIS/ICF cycle together with Sponsor and/or CBU and distribute approved Master SIS/ICF to the countries
  • Oversee Country and/or Site-Specific (*if applicable) SIS/ICF Review/ Finalization and Approval Cycle with Sponsor
  • Draft and contribute as Subject Matter Expert (SME) in the field of Regulatory Oversight activities to the evaluation/improvement of processes and procedures within the Quality Management System

Requirements

To be successful you will possess:

  • Bachelor’s Degree in Healthcare or Biological Science and minimum 3 years of experience in drug development and/or clinical research; or equivalent combination of education, training, and experience
  • 5-10 years of Global Regulatory Submissions experience
  • Thorough knowledge of GxP, GDPR, EU CTR and EU CTD and applicable (local) regulatory requirements
  • Previous sponsor facing experience a significant advantage
  • Good understanding of Regulatory Submission requirements, preferably through several years of Submission experience.
  • Strong written and verbal communication skills including good command of English language
  • Strong organizational skills
  • Representative, outgoing and client focused
  • Ability to work in a fast-paced challenging environment of a growing company
  • Proficiency with various computer applications such as Word, Excel, and PowerPoint required

Benefits

Benefits of working at Allucent include:

  • Comprehensive benefits package per location
  • Competitive salaries per location
  • Departmental Study/Training Budget for furthering professional development
  • Flexible Working hours (within reason)
  • Opportunity for remote/hybrid* working depending on location
  • Leadership and mentoring opportunities
  • Participation in our enriching Buddy Program as a new or existing employee
  • Internal growth opportunities and career progression
  • Financially rewarding internal employee referral program
  • Access to online soft-skills and technical training via GoodHabitz and internal platforms
  • Eligibility for our Spot Bonus Award Program in recognition of going above and beyond on projects
  • Eligibility for our Loyalty Award Program in recognition of loyalty and commitment of longstanding employees

Disclaimers:

*Our hybrid work policy encourages a dynamic work environment, prescribing 2 days in office per week for employees within reasonable distance from one of our global offices.

“The Allucent Talent Acquisition team manages the recruitment and employment process for Allucent (US) LLC and its affiliates (collectively “Allucent”). Allucent does not accept unsolicited resumes from third-party recruiters or uninvited requests for collaboration on any of our open roles. Unsolicited resumes sent to Allucent employees will not obligate Allucent to the future employment of those individuals or potential remuneration to any third-party recruitment agency. Candidates should never be submitted directly to our hiring managers, employees, or human resources.” #JC-1

  • Global Regulatory Manager

    1 month ago

    Bracknell, United Kingdom Allucent Full time

    At Allucent, we are dedicated to helping small-medium biopharmaceutical companies efficiently navigate the complex world of clinical trials to bring life-changing therapies to patients in need across the globe.We are looking for a Global Regulatory Manager (GRM) to join our A-team (hybrid*/remote). The Global Regulatory Manager is responsible for managing...

  • Senior Director/Executive Director, Global Regulatory Affairs-EMEA

    1 month ago

    Bracknell, United Kingdom Lilly Full time

    We’re looking for people who are determined to make life better for people around the world. Purpose: The Senior Director/Executive Director, Global Regulatory Affairs (GRA)-EMEA or Regional Regulatory Scientist is accountable to establish the local regulatory strategy and plan for assigned product(s) in region/country, ensure local plan aligns to...

  • Regulatory Affairs Manager

    4 weeks ago

    Bracknell, Berkshire, United Kingdom Procter & Gamble Full time

    Job Location Reading Job Description P&G is a leading global consumer goods company whose winning brands are Procter & Gamble (P&G) is a leading global consumer goods company whose winning brands such as Gillette, Pampers and Oral-B are built around the model of innovation. Our Personal Healthcare business (Vicks, Seven Seas, Oral-B) is seeking a...

  • Regulatory Manager

    4 weeks ago

    Bracknell, United Kingdom Science Solutions Recruitment Ltd Full time

    This _Regulatory Manager_ role is within an ambitiously expanding manufacturing firm working on active products utilising biocides in formulated household and industrial products. If you are an experienced regulatory professional from an area of regulatedproduct manufacturing (biocides, crop/plant protection, pesticides, insecticides, rodenticides, etc) then...

  • Head of Regulatory Affairs

    3 weeks ago

    Bracknell Forest, United Kingdom BI AH UK Ltd Full time

    **THE POSITION**: **TASKS & RESPONSIBILITIES**: - Accountable for the assembly, submission and follow through of regulatory submissions to obtain and maintain Marketing Authorisations and other necessary licences for UK, Ireland and Malta - Provide regulatory intelligence and advice on regulatory status and requirements, including new developments to...

  • Regulatory Affairs Officer

    3 weeks ago

    Bracknell Forest, United Kingdom BI AH UK Ltd Full time

    **THE POSITION**: You will be responsible for managing the product registration chain, compliance with regulatory authorities and Global Regulatory Affairs (RA), maintenance of product authorisations/licences, and relevant LCM (life cycle management) activities. **TASKS & RESPONSIBILITIES**: - Provide full regulatory support for assigned licensed products...

  • Senior Regulatory Affairs Officer

    6 days ago

    Bracknell, Berkshire, United Kingdom Boehringer Ingelheim Full time

    Job Description THE POSITION Senior Regulatory Affairs Officer We are looking for an experienced and enthusiastic Regulatory Affairs professional looking to take your next step in our UK & Ireland Regulatory Affairs department. You will take responsibility for supporting a range of licensed products throughout the product lifecycle as well as compounds...

  • Regulatory & Policy Coordinator

    4 weeks ago

    Bracknell, United Kingdom Head Office Full time

    **At a Glance** **Contract Type**:Permanent **Location**:Bracknell based with hybrid working with the expectation to go into the office 1 day a week **Salary Range**:£36,400.00 - £54,600.00 per annum **Partnership Level**: 8 **About the role** We have an exciting opportunity to join the Waitrose Technical team as a Regulatory & Policy...

  • Senior Regulatory Affairs Officer

    2 weeks ago

    Bracknell Forest, United Kingdom Boehringer Ingelheim Ltd. Full time

    **THE POSITION**: - _We are looking for an experienced and enthusiastic Regulatory Affairs professional looking to take your next step in our UK & Ireland Regulatory Affairs department. You will take responsibility for supporting a range of licensed products throughout the product lifecycle as well as compounds in the pre-license phase inputting to and...

  • Regulatory Compliance Coordinator Emea

    2 weeks ago

    Bracknell, Bracknell Forest, United Kingdom Proclinical Staffing Full time

    OverviewQualifications, skills, and all relevant experience needed for this role can be found in the full description below.This position is responsible for the continued development and maintenance of our client's world-class regional import-export compliance program. Its focus is to ensure all legal entities operating worldwide are compliant with all...

  • Global Insights Manager

    2 weeks ago

    Bracknell, United Kingdom Remarkable Jobs Full time

    Global Insights Manager (Market Intelligence, B2B)Salary: £depending on experience + benefits Location: Wokingham, BerkshireType: Full Time / PermanentRemarkable Jobs are excited to collaborate with a leading, global organisation providing cutting-edge market research and consultancy for over 30 years. With a focus on delivering top-tier market knowledge,...

  • Global Insights Manager

    7 days ago

    Bracknell, United Kingdom Remarkable Jobs Full time

    Global Insights Manager (Market Intelligence, B2B) Salary: £depending on experience + benefits Location: Wokingham, Berkshire Type: Full Time / PermanentRemarkable Jobs are excited to collaborate with a leading, global organisation providing cutting-edge market research and consultancy for over 30 years. With a focus on delivering top-tier market...

  • Regulatory Compliance Lead

    1 week ago

    Bracknell, United Kingdom Berkshire Healthcare NHS Foundation Trust Full time

    The Regulatory Compliance Lead has a wide range of responsibilities, including but not limited to: Leading the year-round CQC preparation work for the organi s ation Coordinating the response to clinical concerns that come into the organi s ation. Providing support to ensure appropriate information is provided to NHSR for any claims received into the...

  • Regulatory Compliance Lead

    2 weeks ago

    Bracknell, Bracknell Forest, United Kingdom Berkshire Healthcare NHS Foundation Trust Full time

    The Regulatory Compliance Lead has a wide range of responsibilities, including but not limited to:Leading the year-round CQC preparation work for the organi s ationCoordinating the response to clinical concerns that come into the organi s ation.Providing support to ensure appropriate information is provided to NHSR for any claims received into the organi s...

  • Regulatory Compliance Lead

    1 month ago

    Bracknell, United Kingdom Berkshire Healthcare Foundation Trust Full time

    **The must haves for this role**: Extensive experience of embedding strong governance to manage regulatory compliance. A good understanding of the CQC process Experience of facilitating education/workshops with stakeholders Ability to work strategically and at all levels across organisational and professional boundaries and at the patient level. Ability to...

  • Regulatory Compliance Lead

    2 weeks ago

    Bracknell, Bracknell Forest, United Kingdom Berkshire Healthcare Foundation Trust Full time

    Job summary We are seeking a Regulatory Compliance Lead to join our team. The successful candidate will articulate and demonstrate a commitment to ongoing patient and staff safety by building excellent relationships with the clinical and governance staff and leaders on the frontline. Main duties of the job The Regulatory Compliance Lead has a wide...

  • Regulatory Compliance Lead

    4 weeks ago

    Bracknell, United Kingdom Berkshire Healthcare Foundation Trust Full time

    Job summary We are seeking a Regulatory Compliance Lead to join our team. The successful candidate will articulate and demonstrate a commitment to ongoing patient and staff safety by building excellent relationships with the clinical and governance staff and leaders on the frontline. Main duties of the job The Regulatory Compliance Lead has a...

  • Head of Quality, Regulatory

    3 weeks ago

    Bracknell, United Kingdom Head Office Full time

    **Contract Type**: Permanent **Location**: Based in Bracknell with hybrid working, will include travel to suppliers and London ***Salary Range**:£105,000.00 - £158,000.00 per annum **About the role** We have a rare and exciting opportunity to join our Waitrose Own Brand team as a Head of Quality, Regulatory & Technical. This is an inspiring role where...

  • Global Compensation Analyst

    2 weeks ago

    Bracknell, United Kingdom Avis Budget Group Full time

    Reporting to the Global Compensation Director, you will be an integral member of the global compensation team. To be successful in this challenging role, you will be able to contribute to the development and implementation of our compensation planning and design, program administration, analytics, and reporting. You will play a key role in supporting our...

  • Global Compensation Analyst

    2 weeks ago

    Bracknell, United Kingdom Avis Budget Group Full time

    Reporting to the Global Compensation Director, you will be an integral member of the global compensation team. To be successful in this challenging role, you will be able to contribute to the development and implementation of our compensation planning and design, program administration, analytics, and reporting. You will play a key role in supporting our...