Job Title: Director, Regulatory Affairs-Cheshire, CT
Department: Regulatory Affairs
Job Code: PH-AE-080504
Date Available: Immediate
Location: Alexion Pharmaceuticals, Inc.
352 Knotter Drive
Cheshire, CT 06410
Reports to the Sr. Director, Regulatory Affairs. Is responsible for strategic definition/direction and implementation of all Cheshire based regulatory strategies, and ensures that these strategies are consistent with company objectives.
Interacts with members of other departments/areas to plan, compile, write, modify, etc. documentation to be sent to FDA or other regulatory agencies, in support of (e.g.) IND, BLA, DMF, MAAs or other regulatory applications as needed.
Leads all strategic liaison activities with US and Canadian Regulatory agencies.
This position will be the primary point of contact with licensing/development partners for regulatory strategic matters.
The incumbent will be responsible for the growth and adaptation of the Regulatory Affairs department to meet the needs of the company. Will represent the company as needed for regulatory affairs matters.
Lead the Regulatory Affairs Department in the required regulatory related strategy for all research & development candidates and approved products, including line extensions.
Participates in the development project teams to create and communicate regulatory strategy, and for strategic planning and submission of documentation to regulatory agencies as appropriate, such that development timelines and compliance with regulations can be maintained.
Will be responsible for ensuring that Alexion is in compliance with regulatory requirements for all ongoing projects.
Assures that the documentation being provided to regulatory authorities meets standards for completeness and compliance with regulations and company best practices.
Ensures that communications with other groups (QA, QC, Manufacturing, Process Development, clinical, research, etc) to write and generate such documentation occurs and when necessary take the lead in generation / authoring of documents.
Acts as the liaison within Alexion for information requests to and from Regulatory agencies, and is responsible for tracking their progress.
Acts as main Alexion contact for any contract manufacturers, licensers, consultants, etc. regarding timely writing and transfer of regulatory related documentation to/from Alexion.
Will be the lead Regulatory member on project teams for new development candidates, and will participate in the strategy to develop product in a timely fashion, thus expediting generation of clinical supplies, process development and analytical development, in support of new INDs and first in human clinical studies.
Visa Sponsorship Not Available for this Position
Advanced degree or equivalent education in a science.
M.S / PhD, R.Ph., Pharm D. (preferred).
At least 10 years prior experience in Regulatory Affairs within the Pharmaceutical Industry, preferably biotech, or equivalent experience.
Past experience with oncology and/or hematology research / development desirable.
Proven experience in regulatory liaison activities with regulatory agencies, including prior achievement of product approvals, filing of INDs, NDAs, BLAs, MAAs, CTAs, CTXs, etc.
Experience in several regulatory disciplines (e.g. clinical development, CMC, preclinical, advertising and promotion, pre and post-approval activities, product launches, etc.) would be a strong plus.
Good oral and written communication skills.
Ability to handle changing priorities and multidisciplinary tasks.
Incumbent must possess sense of urgency, people skills and be able to thrive in a team oriented, visible small company environment.
Self motivation, team sprit and open communication are essential.
Notes: Alexion Pharmaceuticals is a publicly traded company engaged in the development of novel drugs for the treatment of hematologic disorders, autoimmune diseases, cardiovascular disorders and cancer.
Alexion offers a highly competitive package of base and incentive compensation, group healthcare coverage, tuition reimbursement, relocation assistance, a 401(K) plan.
Alexion is an Equal Opportunity/Affirmative Action Employer.