Senior Regulatory Affairs Manager page is loaded## Senior Regulatory Affairs Managerremote type: Hybridlocations: Basel: Republic of Irelandtime type: Full timeposted on: Posted 6 Days Agojob requisition id: R-***********Job Description:****Senior Regulatory Affairs Manager**The Senior Regulatory Affairs Manager manages assigned regulatory and cross-functional projects; provides strategic and operational support to Veristat clients in regulatory decision-making processes, filings and maintenance of healthcare products and plays a key role in providing consultation to Veristat's clients, in translating regulatory requirements into practical application to ensure the success of clinical trials and regulatory submissions.
S/he will work with project teams, provide advice on regulatory agency interactions, manage agency communications, support the preparation of submissions, and create strong rapport with clients.
**Make an Impact at Veristat!
**Join a global team with more than 30 years of expertise accelerating life-changing therapies to patients worldwide.
* 105+ approved therapies for marketing applications prepared by Veristat* 480+ oncology projects in the past 5 years* 350+ rare disease projects delivered in the past 5 years* Flexible, inclusive culture — 70% remote workforce, 66% women-led teamsLearn more about our core values !
**What we offer*** Benefits vary by location and may include: + Remote working + Flexible time off + Paid holidays + Medical insurance + Tuition reimbursement + Retirement plans**What we look for*** Bachelor's degree in a related field required.
Advanced scientific degree (i.e. PhD or Master's degree) preferred.
* 6 - 8 years of regulatory affairs experience in a clinical research organization and/or pharmaceutical setting (or demonstrated ability to function at this level), with a proven track record of global regulatory submissions* As Senior Manager Regulatory Affairs CMC: familiar with manufacturing, specifications, analytical testing and overall regulatory CMC requirements* Thorough knowledge of International Conference on Harmonisation (ICH) guidelines and regulatory guidelines in the relevant territories as well as drug development, clinical trials, and clinical research* Excellent written and oral communication skills including grammatical/technical writing skills, and familiarity with drug development, agency interactions, study designs and regulatory requirements that apply to clinical trials are required* Demonstrated ability to develop and foster positive client relationships.
* Demonstrated ability to lead by example and demonstrated skill for technical leadership of staff.
* Skilled in use of computer software, including Microsoft Word and Microsoft Excel, and ability to learn new applications.
* Excellent interpersonal, communication, and organizational skills with the ability to work independently and in a team environment.
*Automated Decision Making: All applicants are reviewed by a member of the Veristat Talent Acquisition team; Veristat does not utilize an automated decision-making process.
*#LI-RD1Veristat is an equal opportunity employer.
We celebrate diversity and are committed to creating an inclusive environment for all employees.Veristat is proud to provide exceptional services to our clients, assisting in the successful development of innovations that improve and save lives.
We are equally proud to recruit, develop and retain the best and the brightest talent across a variety of business functions to make that happen.
We are an Equal Opportunity Employer that values the strength and creativity that diversity brings to our workplace.
Veristat provides equal employment opportunities to all employees and applicants for employment without regard to age, disability, genetics, gender identity or expression, gender reassignment (i.e., transgender status), marriage and civil partnership, pregnancy and maternity, race (including color, nationality, and ethnic or national origins), religion or belief, sex or sexual orientation, physical appearance, veteran status, source of income, arrest or conviction record or any other category protected under characteristics considered unlawful in any circumstances of employment offers and practices.
**Reasonable Accommodations**Veristat is dedicated to providing an accessible and inclusive application experience for all candidates.
If you require a reasonable accommodation to complete your application, participate in an assessment, or attend an interview, please contact our Talent Acquisition team at ****** or *************.
We will work with you to meet your needs, ensuring a fair process.
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