Senior Director Regulatory Affairs
6 days ago
Senior Director, Regulatory Affairs – Permanent – Boston, MAReady to make your application Please do read through the description at least once before clicking on Apply.Proclinical is seeking a Senior Director, Regulatory Affairs for a growing and exciting clinical-stage biotechnology company based in the Greater Boston, MA Area.Primary ResponsibilitiesIn this role, you will help drive forward their regulatory strategy and operational activities related to the company’s muscle disease programs. The person in this role must thrive working in a fast-paced environment where flexibility, accountability and fearless innovation are key. Additionally, this individual must have excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic regulatory and strategies. A shared passion for the company’s mission to bring transformative therapies to people living with serious muscle diseases is a must.The position is based in the Greater Boston, MA Area in a hybrid work environment.Skills & RequirementsMinimum of a bachelor\'s degree in life science or related discipline is requiredMinimum of 12 years of experience in regulatory strategy in a clinical-stage biotechnology companyExperience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplementsExperience in Health Authority MeetingsKnowledge of EU and international regulations related to the clinical, nonclinical, and CMC development a plusThe Senior Director, Regulatory Affairs willInteract with other departments to develop regulatory strategy and submission plans for quality and timely filings.As a member of program teams, provide global regulatory guidance regarding requirements for clinical development and registration of pharmaceuticals.Oversee preparation, review and submission of regulatory documents maintaining compliance with regulatory requirements.Manage timelines and preparation of meeting requests and briefing documents.Author/edit documents to support regulatory submissions.Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.Manage and ensure compliance with all reporting requirements, including annual and periodic reports.Support the organization with health authority meetings.Provide strategic guidance for and author applications related to expedited programs/ designations for rare muscle disease (e.g. Fast Track, Orphan Drug Designation, etc.).If you are having difficulty in applying or if you have any questions, please contact Phu Huynh at ( or Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies. xpwpeyx Proclinical Staffing is an equal opportunity employer.Seniority levelDirectorEmployment typeFull-timeJob functionScienceIndustries Biotech Research and Pharmaceutical Manufacturing#J-18808-Ljbffr
-
Director Global Regulatory Affairs
7 days ago
Boston, United Kingdom Barrington James Full timeDirector Global Regulatory Affairs About the CompanyOur client is a clinical‑stage biopharmaceutical company dedicated to developing innovative therapies that address significant unmet medical needs. As the organization advances its pipeline through clinical development, we are seeking a skilled Global Regulatory Affairs Director to join the team and play...
-
Boston, United Kingdom The Elle Group Full timeSenior Medical Director, Clinical DevelopmentWe are partnering with a clinical-stage biotechnology company focused on developing innovative therapies for solid tumors. We are seeking a Senior Medical Director, Clinical Development to join their growing global team.About the OpportunityIn this role, you will serve as the clinical lead for one or more oncology...
-
Deputy Director, Financial Sustainability
4 weeks ago
Boston, United Kingdom Office for Students Full timeOffice for StudentsAll the relevant skills, qualifications and experience that a successful applicant will need are listed in the following description. Deputy Director, Financial Sustainability Salary: c.£130,000 (and £3,566 London weighting where relevant) plus Civil Service pension Location: Bristol or London Closing Date: 5pm on Monday 17th November...
-
Director, Medical Education Marshfield
1 week ago
Boston, Lincolnshire, United Kingdom Sanford Health Full time £70,000 - £110,000 per yearSanford Health is one of the largest and fastest-growing not-for-profit health systems in the United States. We're proud to offer many development and advancement opportunities to our nearly 50,000 members of the Sanford Family who are dedicated to the work of health and healing across our broad footprint. Work Shift:Scheduled Weekly Hours:40Union Position:...
-
Associate Director, Market Research
3 days ago
Boston, United Kingdom Barrington James Full timeAssociate Director, Market Research (D2C) Our client is a leading private pharmaceutical company, covering a vast portfolio of products across the globe. Creating huge breakthroughs in global health and innovation in both human and animal, with an infinitely increasing pipeline. The Associate Director (AD) of Market Research - Direct to Consumer will be...
-
Associate Director of Development
4 weeks ago
Boston, United Kingdom Millfield School Full timeMillfield is one of the UK’s most dynamic and diverse independent schools, with a bold mission to Discover Brilliance in Every Child. As one of the largest co-educational boarding and day schools in the UK it has the resources to offer world leading teaching and coaching. There are nearly 1,300 students at the senior school (aged 13-18), with a 3:1 ratio...
-
IT Risk and Controls Director
1 day ago
Boston, Lincolnshire, United Kingdom Embark Full time $175,000 - $210,000Experience a 45X+ award-winning cultureEmbarkers enjoy:Work-life integration: We encourage our team to balance work with personal life. 95% of our employees feel they can take time off when necessaryGrowth and development: We offer continuous learning opportunities, including CPE credits and coaching, to support our employees' professional growth and ensure...
-
HR Senior Administrator
3 days ago
Boston, United Kingdom South Lincolnshire Academies Trust Full timeHR Senior Administrator South Lincolnshire Academies Trust wish to appoint a highly skilled and experienced Senior Administrator to support the Human Resources Director at either Cowley Academy or Giles Academy. This is an excellent opportunity to join a thriving and highly motivated Trust who take pride in the high staff retention rates and wellbeing of...
-
Executive Director, Drug Product Innovation
6 days ago
Boston, United Kingdom Meet Life Sciences Full time £125 - £150OverviewExecutive Director, Drug Product InnovationMaking sure you fit the guidelines as an applicant for this role is essential, please read the below carefully.This role is a strategic addition to a growing biotherapeutics R&D team focused on advancing parenteral drug product development. The team supports the formulation and commercialization of...
-
Senior Accounts Assistant
1 day ago
Boston, United Kingdom Warden Agri Ltd Full timeWarden Agri is a fast paced growing agricultural and waste to green energy business based in Midville (Nr. Stickney, Boston). We are a highly focused team looking for an efficient **Senior Accounts Assistant.** The applicant must be enthusiastic and an excellent communicator. He or She must have an eye for detail and precision and must ensure that any job...