In addition to each Alumni Career Paths panel discussion, we ask our panelists several fundamental questions about their fields so you don't have to! Use the answers they've provided below to get a quick take on whether you want to further investigate this career path, learn about the differences between roles and organizations in this field, and as a starting point for informational interviews if you want to learn more:
- What are the responsibilities of someone in your role?
- Is a postdoc required, recommended, useful, or unnecessary to enter or excel in this field?
- What types of experience are important to highlight in your resume and interview?
- What characteristics make someone good at this position?
- What do the typical application and interview processes entail?
- What possibilities do international folks have to work at your company/organization?
Regulatory and Clinical Affairs questions answered in November 2021 by:
Patrick Heiser, PhD
Associate VP, Clinical Development, Ferring Pharmaceuticals (UCSF Alumnus, Biomedical Sciences 2007)
Brandi Saunders, MS
Principal Consultant, Opus Regulatory (UCSF Alumna, Nursing 2004)
Regulatory and Clinical Affairs questions answered in November 2020 by:
Leslie Ann Cruz, PhD
Senior Manager, Regulatory Affairs, Natera (UCSF PhD in Chemistry and Chemical Biology, 2010)
Latika Kohli, PhD
Associate Program Director, Regulatory Affairs, Genentech (UCSF postdoc alum, 2014)
Yelena Kulik, PhD
Clinical Science Assistant, Genentech (UCSF PhD in Neuroscience, 2019)
What are the responsibilities of someone in your role?
Patrick Heiser
- Prepare clinical development plans which integrate clinical, regulatory, and commercial strategies.
- Design Phase 1-4 clinical trial protocols.
- Serve as medical monitor for ongoing trials.
- Ensure that the quality of data being generated is high and that adequate safety is maintained for trial subjects.
- Analyze and interpret clinical trial data.
- Contribute medical and scientific input to Investigator’s Brochures, trial reports, regulatory briefing packages and the clinical part of the NDA/BLA dossiers.
- Write publications detailing trial findings.
- Participate in FDA meetings and interactions to support clinical development projects.
Brandi Saunders
Regulatory Affairs Advertising and Promotional Strategy & Compliance involves many responsibilities focused on ensuring that a company is compliantly promoting a pharmaceutical product while remaining competitive. This role requires you to be a liaison between FDA’s Office of Rx Drug Promotion and your company or client(consultant). Happy to share more!
Leslie Ann Cruz
The responsibilities of a regulatory professional is to work with internal teams and external regulatory agencies to register products (drug, biologics, medical device, in vitro diagnostics) that are safe and effective.
Latika Kohli
- Interpreting the needs of worldwide health authorities to guide drug development programs at various phases from early development to post-marketing
- Develop and implement regulatory strategies and drive submissions to enable approval of drugs and maintenance of licenses
- Conduct regulatory due diligence during evaluation of potential external partnerships
- Develop positions on evolving regulations and collaborate with health authorities to contribute towards shaping the external environment
- Participate as a standing member on one or more cross functional molecule teams as the regulatory global or regional representative and channel key takeaways from internal and external developments and trends to provide relevant regulatory guidance to team members
- Develop a regulatory engagement plan with health authorities to seek buy-in on molecule development strategies and drive interactions
- Serve as the interface with primary reviewers from health authorities or as the regulatory representative with external parties
- Oversee, coordinate and provide a first-line of internal approvals for regulatory submissions and other relevant regulatory documentation
- Train, coach and mentor new and less experienced colleagues
- Participate in initiatives to develop and implement new processes, ways of working, SOPs etc
Yelena Kulik
- Designing and implementing clinical trials
- Creating clinical study protocols, informed consent forms, investigator brochures, clinical progress and safety reports, etc
- Reviewing, analyzing, presenting clinical data
- Representing the clinical science function at cross-functional team meetings
- Working very closely with other functions (operations, safety, biostatistics, regulatory affairs, medical affairs)
Is a postdoc required, recommended, useful, or unnecessary to enter or excel in this field?
Patrick Heiser
Recommended. Completion of a post-doctoral fellowship elevates the desirability of external candidates, ensures a higher salary offer, and can enable faster growth within the company. However, it is not typically a requirement for roles within medical affairs or clinical development.
Brandi Saunders
Unnecessary
Leslie Ann Cruz
No, a postdoc is not required to enter into regulatory affairs. I do think that the skills that one learns as a graduate student and postdoctoral scholar are useful in quickly succeeding in regulatory affairs. Having a critical mind and superb writing/communication skills helps immensely.
Latika Kohli
Not necessary. A background in biological sciences is definitely key to ensuring the ability to engage and speak the language of cross functional stakeholders in drug development. Advanced degrees are not a prerequisite for a regulatory role. However, there are several transferable skills like critical thinking, domain knowledge, complex stakeholder management, document reviews, communication and presentation skills, dealing with ambiguity etc that one ends up developing in an academic research based role that can set you up for success in this role.
Yelena Kulik
Unnecessary.
What types of experience are important to highlight in your resume and interview?
Patrick Heiser
- Any relevant pharmaceutical or biotech experience, even if it is just external collaborations or paid consultancies.
- Expertise in projects related to translational medicine--bringing insights from the bench towards the clinic.
- Deep therapeutic area knowledge in an area of interest for the prospective employer.
- Demonstration of knowledge of the company's marketed products and those in the pipeline based on whatever is publicly available. It is impressive when candidates have taken the time to read publications describing pivotal trials--and can ask intelligent questions about trial design and interpretation of results.
- Research the people you will be interviewing with. As with #4--it will make you stand out. Shockingly few people do enough homework before their interview.
Brandi Saunders
- Any clinical experience you may have is good to emphasize.
- Your ability to understand and apply data (clinical trial)
- Scientific background
- Hard (technical or area of expertise) and Soft skills (people skills)
Leslie Ann Cruz
Extensive scientific writing experiences, collaborative experiences with other colleagues/departments, any projects that included any regulatory experience.
Latika Kohli
In the absence of direct practical experience, focus on transferable skills, as mentioned above. In particular, highlight activities where you could have gained clinical drug dev experience (any involvement in designing or reviewing proposals for drug trials, esp. in humans, IRBs etc), or managed external relationships (partnering labs, institutions), served as reviewer for journals etc.
Yelena Kulik
- Any prior experience supporting clinical trials
- Any prior experience working on drug development in biopharma
- Written and oral communication (presentations, papers authored)
- Collaborations
NOTE: you do NOT have to be an expert in the disease area the clinical trials are in; many people move around therapeutic areas throughout their careers. Though of course it cannot hurt to highlight if you happen to be a subject matter expert
What characteristics make someone good at this position?
Patrick Heiser
- Curiosity
- Analytical and strategic thinking
- Exquisite attention to detail
- Good interpersonal skills and eagerness to collaborate
Brandi Saunders
- Ability to understand scientific data and clinical trials
- Ability to easily build and maintain relationships
- Detail Oriented
- Able to adapt to a fast changing environment
- Solution Oriented
- Positive attitude
- Ability to work well in teams and independently
Leslie Ann Cruz
Being a team player, attention to detail, process-oriented, ability to look at projects from a high level and at a very detailed level. Enjoys reading the regulations, writing, and creating documents/forms/checklists. Able to work with a wide variety of people from various backgrounds/disciplines.
Latika Kohli
- Communication skills: written and verbal. Ability to message complex and difficult messages in a simple and effective manner
- Ability to manage by influence
- Change management skills: ability to adapt as needed
- Ability to switch between seeing the big picture and diving into details
Yelena Kulik
- Good team player
- Great oral, written, and interpersonal communication skills
- Analytical
- Strong ethics
What do the typical application and interview processes entail?
Patrick Heiser
Meetings with leaders of the clinical, regulatory affairs, medical affairs, pharmacovigilance, and commercial departments. For some positions, you may be asked to present your research--to better understand your communication skills.
Brandi Saunders
It varies by company but generally speaking you apply via the company’s website or linked in page. If selected for an interview, you will likely have a series of interviews with the various functions that you will be working with. Those include other colleagues in Regulatory Affairs, Marketing, Market Access, Medical Affairs, Legal, Compliance and HR.
Leslie Ann Cruz
- Applicant sends in application
- Human Resources (HR) reviews and conducts an initial phone screen
- Hiring manager decides who to interview based on HR screen
- Hiring manager conducts phone interviews
- Hiring manager decides which candidates move on to the panel interview
- Panel interview is conducted
- Based on panel interview feedback, the hiring manager decides which candidate to hire
Latika Kohli
Typically, there is a phone interview followed by a full day series. Interviews for entry level positions largely consist of a series of behavioral questions that focus on evaluating following key aspects:
- Communication skills
- Transferable skills
- Conflict resolution
- Stakeholder management and collaboration
- Comfort level with ambiguity and decision making
Yelena Kulik
Application involves submitting your CV and cover letter online, then multiple rounds of interview if you are selected. Interview questions are mostly behavioral (ex. 'tell me about a time you faced conflict while working in a team. what did you do?'). Many questions try to get at whether you are good at collaborating, influencing. Very few or none at all ask about technical expertise.
What possibilities do international folks have to work at your company/organization?
Patrick Heiser
In a tight labor market (such as the one we face now), my organization is open to international candidates depending on the position.
Brandi Saunders
If you decide to work for a biotechnology/Pharma company that has an international presence (affiliate offices in regions or individual countries) then you will likely have opportunities both OUS and in the US.
