Associate Manager/ Manager Regulatory Affairs

Position Description:

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

Abilities:

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

Minimum Qualifications:

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

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