Associate Manager/ Manager Regulatory Affairs
- Responsible to ensure all RA deliverables of moderate complexity associated with each project or other assignment are completed within defined timelines and meet regulatory and other company guidelines
- Contributes to the development and critical Regulatory review of documents required in support of assigned projects (eg, Type A, B or C Meeting requests, FDA, periodical reports, responses to Competent Authorities)
- Provides regulatory expertise as appropriate and guidance to cross-functional teams and other groups
- May serve as the primary RA representative on one or more projects at any one point in time
- Collaborates with the teams in providing direction on regulatory authority interactions
- Develops regulatory risk management and contingency plans.
- Participates as a standing member in various teams, dependent upon assigned projects and the associated programs and experience
- May at times be required to travel
- Outstanding attention-to-detail
- Knowledge of the pharmaceutical/biotechnology industry, the multiple functions and roles involved in the product development process.
- Knowledge and understanding of US regulations and guidelines
- Experience in the preparation and submission of regulatory documents in support of an IND
- Can prioritize multiple tasks and goals to ensure the timely, on-target accomplishment of such
- Strong interpersonal, verbal communication and influencing skills: can influence without authority and has proven experience building and cultivating relationships with key partners and stakeholders, both internally and externally
- Outstanding written communication skills
- Confident and competent when interacting with varying levels of internal/external management: stays focused and on-point, is able to raise problems or challenges in a productive and mature manner
- Strong negotiation skills: can effectively drive discussions and decisions toward desired end-results
- Works well within teams and is effective in collaborating with others internally and externally
- Bachelors Degree required (life sciences disciplines strongly preferred)
- Average of 3-5 years' of relevant experience in regulatory affairs or related functions in drug/biologics development/manufacturing
- Broad understanding of international regulations, processes and issues in drug/biologics development.
- Experience as a regulatory contributor for global original IND/NDA/MAA filings in the US or Europe is preferred
- Strong computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat