ProClinical Recruitment, in partnership with IDT Biologika Corporation (IDT, Rockville, MD) is actively recruiting for a Senior Regulatory Affairs Associate, Veterinary Vaccines, Animal Health (Americas) position.
Serve as the U.S. "Permittee" for IDT products manufactured outside of the jurisdiction, and fulfill U.S. import requirements for vaccines and diagnostics for trans-boundary animal diseases and other animal health products.
Represent Regulatory Affairs-Americas on cross-functional and cross-cultural project teams.
Plan, create, submit, and manage dossiers and all regulatory documents presented to regulatory authorities in the region.
Perform reviews of regulatory documents, labels, etc. for compliance with stated requirements.
Manage documentation, including labels, timely submission of annual revisions, new registrations, licenses, permits and other regulatory submissions to regulatory authorities.
Assure compliance with Regulatory Agency regulations and interpretations.
Communicate effectively with regulatory authorities.
Integrate and execute results-oriented Regulatory Affairs strategies that are aligned with organizational objectives. Take accountability for the achievement of business goals and objectives.
Define decision criteria and consider benefits, risks and alternatives for decision making.
Provide a detailed scientific and technical understanding of veterinary vaccines to provide strategic guidance and support for portfolio and life-cycle management of products.
Interact effectively and regularly with headquarters’ regulatory group and with regional personnel.
Partner with other functions in developing roadmaps for submission, product launches, and new products.
Write and review applicable SOPs as necessary.
Manage applicable audits, compliance and risk management functions.
Skills And Qualifications
Bachelor's degree in life sciences or veterinary fields (Master's degree preferred).
5+ years of experience in in the Animal Health industry involving vaccines and/or biologics.
5+ years of experience in regulatory affairs for veterinary vaccines and working with U.S. government agencies and Canada (Latin America strongly preferred).
Previous experience in regulatory submissions or interactions with USDA.
Experience with EU design dossiers and technical files.
Experience as a U.S. permittee.
Fluent in English with strong verbal and written communications skills and a second language (German, French or Spanish strongly preferred).
Experience in working in a cGMP environment.
Demonstrated ability to manage multiple projects/tasks; project management experience.
Familiarity with financial statements and applicable information technology.
Advance your career by joining an international team within a fast-growing organization at IDT.
IDT offers a competitive compensation package to include major medical/dental/vision, group life insurance, STD/LTD plans, 401K plan with company match, and paid vacation, sick and holidays. If interested in being part of a dynamic and growing company, please email your resume and cover letter to: Darren Whyte at ProClinical at firstname.lastname@example.org.
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status andwill not be discriminated against on the basis of disability.
At ProClinical, we care about enabling life science companies to treat patients in areas of unmet medical need. That’s why we partner with them to recruit the best people, who can make the most impact, for each individual role.
ProClinical is a leading global recruitment company that operates exclusively within the life sciences industry. We have a proven track record of having filled thousands... of permanent and contract vacancies at pharma, biotech and medical device companies, contract research organisations (CROs) and other life sciences companies across the USA, Europe and Asia.