Proclinical is currently recruiting for an RA Manager with a leading biopharmaceutical company located in Parsippany, NJ. As the Regulatory Affairs Manager, you will be responsible for the regulatory operations for project development activities and assistance of project clinical regulatory lead for global clinical studies.
- Plan, implement, manage and report regulatory activities and submission timelines for global clinical studies.
- Manage review, formatting and ensure regulatory documents to be submission ready to regulatory agencies including FDA, HC, and EMA.
- Manage archive of regulatory documents submitted to regulatory agencies including FDA, HC, and EMA.
- Help to manage project development timeline and cost and ensure that project activities are delivered on time and on budget.
- Organize and facilitate meetings internally and with outside parties.
- Perform other tasks and functions as required or needed.
Skills and Requirements:
- Bachelor's degree in related field. Advance degree is preferred but not required.
- Minimum of 5 years of regulatory experience in the biotech/pharmaceutical industry; experience in the hematological malignancies, neuromuscular or orphan diseases is a plus.
- Experience dealing with multiple aspects of regulatory affairs (CMC, clinical, nonclinical) is strongly preferred.
- Experience with post-approval regulatory requirements and activities preferred.
- Functional knowledge of US regulatory requirements pertaining to the development and registration of pharmaceutical products.
- Experience with IND and NDA filings is required.
- Working and/or in-depth knowledge of regulatory affairs.
- Must be able to work effectively in a multi-cultural, global team environment as responsibilities include intensive drug development collaboration with global project teams, external partners and vendors.
- Strong computer skills, and proficient in MS applications (Word, Excel, PowerPoint).
- Ability to handle multiple tasks and prioritize.
- Strong organizational, communication and presentation skills.
- Team player, flexible, ability to adapt to change.
If you are having difficulty in applying or if you have any questions, please contact Nick Walker at (+1) 646-367-2908 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.