What are the responsibilities and job description for the Associate Director of Regulatory Affairs position at Scientific Search?
Associate Director Regulatory Affairs
Onsite in Nashville, TN (Relocation will be provided)
Company Profile: a 25-year-old specialty pharmaceutical company based in Nashville, Tennessee. The company focuses on the development and commercialization of branded prescription products for underserved medical needs.
What You Can Expect To Be Doing
Onsite in Nashville, TN (Relocation will be provided)
Company Profile: a 25-year-old specialty pharmaceutical company based in Nashville, Tennessee. The company focuses on the development and commercialization of branded prescription products for underserved medical needs.
What You Can Expect To Be Doing
- Assist with the management and oversight of the pharmaceutical company’s Regulatory activities including the design and implementation of clinical studies and preparation of preapproval and post-approval regulatory submissions.
- Participate in the preparation and review of a variety of regulatory documents including NDA, INDs, and their amendments and supplements.
- Help with the preparation and review of Annual Reports for the Company’s approved brands and investigational candidates.
- Participate on a multi-disciplinary team to achieve key corporate objectives.
- Support the development of the strategy and position to achieve approval of all regulatory submissions and filings.
- Manage regulatory activities for key projects and coordinate department activities associated with filings.
- Provide expert guidance for the design, execution, and reporting of clinical trials across all phases of development.
- Help develop and foster a positive organizational culture by promoting the values of focusing on patients, science, and people.
- Ensure compliance with U.S. and international regulations.
- 5-10 years industry experience; Regulatory experience; track record of successful IND and NDA/BLA submissions and approvals; experienced in eCTD submissions for INDs and NDAs; familiarity with advertising/promotional requirements and labeling; superior product development strategy skills; strong teamwork skills; excellent verbal and written communication skills.
- BS required, with advanced degree preferable.
