Regulatory Affairs Specialist
4 weeks ago
Allergan is dedicated to discovering and delivering innovative medical solutions that address significant health challenges today and in the future. Our commitment is to make a meaningful difference in the lives of individuals across various therapeutic domains, including immunology, oncology, neuroscience, and eye care, as well as through our Allergan Aesthetics offerings. For further details about Allergan, please visit our website.
Position OverviewObjective
Facilitate, prepare, or evaluate regulatory submissions for both domestic and international initiatives.
Key Responsibilities
- Conduct a thorough technical assessment of data or reports intended for regulatory submissions to ensure scientific integrity, precision, and clarity in presentation.
- Examine promotional materials, labeling, batch records, specification sheets, or testing methodologies for adherence to relevant regulations and policies.
- Maintain an up-to-date understanding of current and emerging regulations, standards, or guidance documents.
- Interpret regulatory guidelines or changes and ensure their communication through corporate policies and procedures.
- Identify the necessary types of regulatory submissions or internal documentation required for scenarios such as proposed device modifications or labeling updates.
- Advise project teams on matters such as premarket regulatory obligations, export and labeling requirements, or compliance issues related to clinical studies.
- Prepare or sustain technical documentation as needed to secure and maintain product approvals.
- Coordinate activities related to the preparation of regulatory documents or submissions.
- Draft or oversee the creation of additional information or responses as requested by regulatory authorities.
Essential Qualifications
- A minimum of 3 years of professional experience, with at least 2 years in Regulatory Affairs, R&D, or a related field.
- At least 1 year of experience in pharmaceutical regulatory affairs is preferred.
- Experience interacting with government regulatory bodies and demonstrated ability to develop and implement effective regulatory strategies.
- Experience with biologics is advantageous. Background in Gastroenterology, Liver, Cardiovascular, Urology, CNS, or Vaccines is a plus.
- Proficient in English, both written and verbal.
- Competent in computer operations.
- Willingness to travel as necessary.
- Experience in a complex, matrixed environment is required based on individual capabilities.
- Current knowledge of relevant legislation.
- Self-driven and motivated.
Allergan is an equal opportunity employer committed to integrity, innovation, community service, and embracing diversity and inclusion. We strive to employ qualified individuals of the highest caliber without discrimination based on race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, veteran status, or any other legally protected status.
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