Regulatory Affairs Associate/Senior Associate
Location: Redwood City, CA/Remote
The Associate/Sr. Associate Regulatory Affairs is an experienced professional who will support Senior Regulatory Affairs management in day-to-day operational aspect of the department and will support interactions with global regulatory authorities.
Principle Duties and Responsibilities Include:
- Develop and keep detailed timelines for regulatory activities and submissions and assure planning and coordination of activities
- Coordinate the content development process (planning, creation, review and approval) of selected regulatory documentation for inclusion in submissions to health authorities
- Compile regulatory submissions that meet ICH requirements, other local or regional regulatory requirements, as applicable, and company policies and procedures
- Assist in preparation and review of select regulatory submission documents. Format, edit, and proof documents according to guidance and internal SOPs
- Maintain regulatory archival database – ongoing update of database with regulatory submissions and correspondence. Assist in the development and implementation of SOPs and systems to track and manage product-associated events
- Participate in coordinating with external vendors and CROs supporting regulatory submission related tasks
- Investigate and evaluate regulatory history/background of class, disease/therapeutic/diagnostic context to assist in assessment of regulatory implications for development and approval. Assist in the development of regulatory strategy and update strategy based upon regulatory changes
- Stay abreast of changes in the regulatory environment and guidelines (e.g., FDA, ICH) in areas relevant to company projects
- Work with manager on acquisition and development of required regulatory skills and knowledge
- Bachelor’s degree required; understanding of genetic disorders, rare diseases, and/or pediatric clinical studies desired
- Minimum 2 years of relevant experience are required, ideally with experience in the biotechnology or pharmaceutical industry.
- Familiarity with regulatory requirements for development of drug and biological products, including FDA regulations and guidance, and ICH guidelines
- Willing to advance knowledge of regulatory practice through classes, certifications, webinars, etc.
- Technical expertise with Windows, MS Office (Outlook, Word, Excel), Adobe Acrobat software systems, and experience working in an electronic document management system
Preferred Experience, Special Skills and Knowledge:
- Strategic agility, ability to work well under pressure, and strong attention to detail with commitment to quality in all areas of responsibility
- Ability to work effectively in both a collaborative and an independent manner in a start-up environment; must interact in proactive, honest, and productive manner while focusing on milestones, compliance, and key decisions needed to advance program
- Strong organizational and time management skills; ability to work on multiple projects and adhere to timelines
- Demonstrated ability to coordinate and work effectively with cross-functional teams
- Strong verbal, written, and interpersonal communication skills
- Attention to detail
Interested and qualified candidates should send their resume to firstname.lastname@example.org to the attention of Human Resources.
Rezolute (RZLT) currently anticipates the base salary for the Regulatory Affairs Associate/Senior Associate role could range from $85,000 to $105,000 and will depend, in part, on the successful candidate’s geographical location and their qualifications for the role, including education and experience. This position will also be eligible for an annual performance bonus in accordance with the terms of the applicable plan (depending, in part, on company and individual performance and at the Company’s discretion on an individual basis). The compensation described above is subject to change and could be higher or lower than the range described based on current market survey data and the qualifications, education, experience and geographical location of the selected candidate.
Qualifying employees are eligible to participate in benefit programs such as:
- Health Insurance (Medical / Dental / Vision)
- Disability, Life & Long-Term Care Insurance
- Holiday Pay
- Tracking Free Vacation Program
- 401(k) Plan Match
- Educational Assistance Benefit
- Fitness Center Reimbursement
We are an Equal Opportunity Employer and do not discriminate against applicants due to race, ethnicity, gender, veteran status, or on the basis of disability or any other federal, state or local protected class.