Our client is a clinical-stage biopharmaceutical dedicated to discovering, developing and commercializing novel therapeutics to treat blood-based disorders with significant unmet need. The organization has multiple prospects in the clinical pipeline across early and late stage trials with excellent prospects for success.
The Senior Manager of Regulatory Affairs will provide leadership on global clinical regulatory activities for compounds. Responsibility will mainly focus on clinical regulatory filings and providing strategic as well as operational leadership on the project teams in this area. In addition, responsibilities will include support to on-going clinical activities. The candidate will contribute and/or lead IND/CTA and NDA submissions activities, as well as international submission activities, for the product candidates.
- Provide interpretation of regulatory authorities’ feedback, policies and guidelines to company personnel.
- Develop regulatory strategic plans in conjunction with project teams and assist in the preparation of clinical submissions required for regulatory approval.
- Work 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.
- Responsible for filing of IND/CTA and contribute and/or lead NDA/MAA submission activities. Interacts with other functions and external vendors, as necessary, in the preparation, review, and completion of documents for regulatory submissions.
- Effectively plan, organize, and conduct in close collaboration with leads from other functional areas. Assure compliance with project team timelines and milestones.
- Provide organizational support and be prepared to manage personnel as company grows its product development pipeline.
Skills and Requirements:
- Bachelor’s degree in a Life Sciences discipline or equivalent, advanced degree preferred.
- Must have 5 to 8 years of biopharmaceutical experience, and at least 5 years of hands-on regulatory affairs and successful IND and NDA/MAA submission experience
- Balance strategic thinking and strong analytical skills with ability to execute. Detail oriented with strong written, verbal communication and presentation skills.
- Experience with international and particularly EU regulatory submissions and an understanding of worldwide small molecule guidelines and regulations a plus.
Please click on the Apply button. Please include a short note outlining why you are interested in the role and why you think you are suitable.
In case you have difficulty in applying or if you have any questions, please call Matthew Tong on +1 646 878 6308or upload your resume on our website - www.proclinical.com.
A full job description is available on request.
ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.