Manager, Regulatory Affairs
Categories: Regulatory
Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully-integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.
Position Summary:
The Manager, Regulatory Affairs will be responsible for supporting regulatory strategy implementation for development programs. Works closely with the Sr. Director, Regulatory Affairs to prepare regulatory submissions (authoring, timeline planning, etc.), to support regulatory and clinical objectives. Assists in developing and implementing global regulatory strategies. Assists in the establishment and maintenance of department regulatory processes. The individual is expected to develop collaborative and productive partnerships internally, as well as externally with contract research organizations, electronic publishing, and other vendors as required.
The Manager, Regulatory Affairs will be responsible for supporting regulatory strategy implementation for development programs. Works closely with the Sr. Director, Regulatory Affairs to prepare regulatory submissions (authoring, timeline planning, etc.), to support regulatory and clinical objectives. Assists in developing and implementing global regulatory strategies. Assists in the establishment and maintenance of department regulatory processes. The individual is expected to develop collaborative and productive partnerships internally, as well as externally with contract research organizations, electronic publishing, and other vendors as required.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
These may include but are not limited to:
- Actively participate as a member of Regulatory Affairs teams and on cross-functional product development teams as needed.
- Contribute to developing and implementing regulatory strategies for global submissions from early research and development (R&D) through commercialization.
- Support the compilation, review and/or filing of INDs, CTAs, briefing documents and maintenance of development and approved applications.
- Coordinate and contribute to the authoring of submission documents such as DSURs, annual reports, and amendments as needed.
- Develop and manage project timelines for regulatory submissions.
- Maintain effective interactions with all contributors and Regulatory Affairs management, to ensure timely delivery of documents for regulatory submission.
- Provide regulatory assistance and review of clinical study documentation, including review of clinical protocols, informed consent documents, clinical study recruitment materials, and essential document packages.
- Track submissions, correspondence, and commitments with health authorities.
- Provide guidance to project teams to ensure regulatory documentation is complete, accurate, of high quality and electronically functional.
- Write and/or maintain standard operating procedures, department working practices, templates and style guides, as appropriate.
Education and Experience:
Required:
Required:
- Bachelor’s or M.S./Ph.D. degree in scientific area.
- Minimum of 7 years with Bachelor’s or 5 years with M.S./Ph.D. of relevant Regulatory Affairs experience in a biotech/pharmaceutical setting.
- Minimum of 2 years supervisory experience.
- Equivalent combination of relevant education and applicable job experience may be considered.
- Experience and understanding of International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) and FDA regulations.
- Experience and knowledge in the preparation of regulatory submissions, i.e. US IND and/or NDA sequences.
- Ability to work both independently with direction and within project teams and see all projects through to their completion.
- Excellent written and oral communication skills.
- Strong organizational skills, including the ability to prioritize workload.
- Strong interpersonal skills and the ability to deal effectively with other people/departments.
- Ability to meet deadlines and perform multiple tasks in a fast paced setting
- Software Knowledge: Windows, MS Office (Outlook, Word, Excel, PowerPoint). Knowledge of other software required: Advanced MS Word and Adobe PDF knowledge required.
- Preferred:
- Additional experience with Clinical Trial Authorizations (CTA) and Marketing Authorization Application (MAA) helpful.
- Experience interpreting and applying local regulations and guidance for drug development from early R&D through commercialization.
- Software Knowledge: Electronic document management systems use (e.g., Veeva) highly desired. Publishing experience and/or eCTD knowledge is desired (Lorenz, GlobalSubmit, eCTDExpress, etc).
Physical Demands and Work Environment:
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Physical Activities: On a continuous basis, sit at desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs. may be required. The noise level in the work environment is typically low to moderate. The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Travel:
You may be required to travel for up to 5% of your time.
You may be required to travel for up to 5% of your time.
The Anticipated Base Salary Range: $105,000-$140,000
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance, 20 days of PTO, 10 paid holidays, and a winter company shutdown.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education. Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states. Your recruiter can share more about the specific salary range during the hiring process.
Equal Opportunity Employer:
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Vaccination requirement:
Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.
Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.