Regulatory Affairs
Position Description & Responsibilities
Roles and responsibilities include the following:
- Responsible for MAA submissions to the EMA.
- Performs the coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
- Compiles all materials required in submissions, license renewal and annual registrations. Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Keeps abreast of regulatory procedures and changes. With supervision, may direct interaction with regulatory agencies on defined matters.
- Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors.
- Maintaining departmental records of filings and approvals and tracks related registration activities.
- Interface with various departments to ensure timely preparation and submission.
- Assist in the preparation of Regulatory SOPs.
- Review of Federal Register notices.
- Investigating the impact of global regulatory requirements.
Position Requirements
Successful candidates will have the following:
- Needs to have at least a BS in the sciences, and 2-3 years experience in regulatory affairs, preferably with experience in submissions to the EMA.
- At least 2 years experience in a pharmaceutical industry.
Vanda Pharmaceuticals offers a competitive compensation package with excellent benefits and a 401(k) matching program. Vanda is an equal opportunity employer, committed to the hiring, advancement and fair treatment of individuals without regard to race, color, religion, sex, sexual preference, age, national origin, ethnicity, disability, or any other protected status designated by law.
Applicants should submit a cover letter with their Curriculum Vitae or Resume together with the names, addresses and telephone numbers of 3 references to:
Human Resources
Reference #: R500
Vanda Pharmaceuticals Inc.
9605 Medical Center Drive, Suite 300
Rockville, Maryland 20850
E-mail: careers@vandapharma.com
Website: www.vandapharma.com
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