Director, Regulatory Affairs Policy and Intelligence
Director, Regulatory Affairs Policy and Intelligence
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Job Description
Position Summary:
We are seeking a proactive and strategic Regulatory Policy & Intelligence professional to support our mission to bring transformative therapies to patients with rare diseases. This role will monitor global regulatory trends assess their impact on our pipeline and help shape the regulatory landscape by engaging with policy-setting bodies and industry groups.
The ideal candidate will bring deep knowledge of global regulatory systems (FDA EMA etc.) a strong understanding of rare drug development and the ability to translate evolving regulations into actionable insights for cross-functional teams.
ultrainnovative Tackle rare and dynamic challenges
Work Model:
Flex: This role will typically require onsite work 2-3 days each week or more depending on business many locations the business will set certain days each week that Flex employees are required to be onsite.
Responsibilities:
Regulatory Intelligence
- Monitor and analyze global regulatory developments (laws guidelines precedents) relevant to rare diseases cell/gene therapy and orphan drug designations
- Maintain a real-time intelligence database or dashboard for internal stakeholders
- Conduct competitor landscape analyses on regulatory strategies and product approvals
Regulatory Policy
- Shape external policy through active engagement with regulatory bodies trade associations and working groups (e.g. BIO NORD EFPIA)
- Draft and coordinate company responses to regulatory consultations and guidance documents
- Represent the company in industry policy forums and public-private initiatives
Strategic Advising
- Advise internal stakeholders (clinical regulatory legal CMC etc.) on the impact of regulatory changes
- Support strategy development for interactions with health authorities (e.g. pre-IND scientific advice PRIME/BREAKTHROUGH designation requests)
- Identify opportunities for accelerated pathways and incentives (e.g. Orphan Drug Designation RMAT Priority Review PIP/waivers in the EU)
Internal Education & Communication
- Create and deliver briefings newsletters and training sessions on emerging regulatory trends
- Act as a liaison between regulatory policy and therapeutic area leads providing policy impact assessments tailored to program needs
Requirements:
- Advanced degree preferred (PhD PharmD MD MS in life sciences); Bachelors with strong experience also considered
- 810 years of experience in regulatory affairs policy or intelligence roles in biotech/pharma
- Strong knowledge of rare disease regulatory pathways and designations (FDA Orphan Drug EMA PRIME etc.)
- Demonstrated experience in interpreting and applying global regulatory policy
- Excellent communication collaboration and strategic thinking skills
#LI-CS1#LI-Hybrid
The typical annual salary range for this full-time position is listed below. This range reflects the characteristics of the job such as required skills and qualifications and is based on the office location noted in this job posting. The range may also be adjusted based on applicants geographic location.
This position is eligible for annual bonus and equity incentives. Actual individual pay is determined by demonstrated experience and internal equity alignment.
Pay Range
$225300 - $278300 USD
Ultragenyx Pharmaceutical is an equal opportunity employer and prohibits unlawful discrimination based on race color religion gender sexual orientation gender identity/expression national origin/ancestry age disability marital and veteran status and any other status or classification protected by applicable federal state and/or local laws. Reasonable accommodation will be provided for all protected statuses or classifications protected by applicable law including individuals with disabilities disabled veterans for pregnancy childbirth and related medical conditions and based on sincerely held religious beliefs. Applicants can request an accommodation prior to accepting a job offer. If you require reasonable accommodation in completing this application or in any part of the recruitment process you may contact Talent Acquisition by emailing us at .
It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.
Required Experience:
Director
Employment Type
Full Time
