Primary Responsibilities:    - Provide strategic regulatory plans in Post Market regulatory activities and having a direct role in drafting, reviewing and administering regulatory strategy and policy throughout the development processes. - Work closely and assists Business Development in their efforts to see and secure new products and conduct Due Diligence activities to further ongoing business related activities. Intuitive team player who listens objectively, formulates opinions at meetings, exercises good judgment, asks incisive questions, and creates a constructive, learning environment for all members of the organization.
Tasks Performed:    - The Director of Regulatory Affairs will have a leading role in providing the Regulatory Affairs perspective in due diligence evaluations of external compounds and other Medical or Commercial development opportunities and interact with potential development partners on diligence projects and represent AMAG Regulatory Affairs in joint development partnerships discussions. He/She will provide support during due-diligence audits including product in-licensing and/or out-licensing and partnership agreements for product co-development. - The Director of Regulatory Affairs will effectively negotiate with regulatory authorities and contribute to the development of biopharmaceutical products by managing and submission of product packages of high quality and ensure compliance with local, state, federal and international laws, guidelines and regulations. The incumbent will ensure that the quality and content of submissions will lead to successful and timely approval of regulatory applications
Essential Functions:    - Provides top level regulatory expertise and regulatory thought leadership for the corporation and the external community. Strong knowledge of US Regulatory Affairs and Ex-US regulations and a good understanding of the drug development process are necessary to accomplish this position requirements - Directs the regulatory operations and activities of all post-marketing and due-diligence functions, by providing strategic direction and clearly defining optimum requirements. Direct the available resources to ensure all regulatory activities for development and marketed products achieve commercial objectives and success. Develops and implements policies in compliance with strategic goals and initiatives that will have Company-wide impact.
Minimum Physical Requirements:   
Desired Education:   
Desired Degree:     Bachelors Degree, Masters or PhD in Science or Arts
Desired Major:   
Desired Job Experience:   
Certifications Required:   
Other Qualifications:    A seasoned Regulatory Affairs expert with at least 8 years of relevant pharmaceutical experience, including 5 years of Regulatory Affairs in direct management experience. Good interpersonal skills with knowledge of basic negotiations, influencing and conflict management to assure effective interactions within and across departments. RAC certification preferred and Experience working US and international submission.