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Senior Manager, Regulatory Affairs International

Basel

 

MISSION

Mirum Pharmaceuticals is a biopharmaceutical company dedicated to transforming the treatment of rare diseases affecting children and adults. Propelled by our passion for patients and their families, we’re focused on turning possibilities into realities. Using data and meaningful evidence, our goal is to transform scientific discoveries into therapies that are poised to positively impact the treatment of rare diseases. We are collaborative, creative, and experienced professionals and we’re looking to augment our team with other individuals who embody our values: care, be real, get it done, and have fun, seriously. Learn more about our work, our culture, and what it’s like to be a part of our team: www.mirumpharma.com.

 

 

POSTION SUMMARY

The Senior Manager, Regulatory Affairs provides support in the implementation of regulatory strategies & deliverables for a portfolio of in early/late development or marketed products for the European region, including EU countries, Switzerland and GB.

JOB FUNCTIONS/RESPONSIBILITIES

  • Support the product leads in the implementation of regulatory strategies & deliverables including effective planning, tracking, archiving of activities.
  • Support the execution of life cycle management activities including submissions in EU, GB and CH of variations, PSURs, Renewal procedures, for marketed products.
  • Prepare and coordinate the regulatory documentation to support clinical trial applications and amendments For the development products.
  • Support pre-MAA activities such as ODDs applications, PIPs preparation and maintenance, Scientific Advice Meetings.
  • Interact with the Regulatory, Clinical Development, Clinical Operations and other functions to ensure optimal execution of the agreed regulatory strategy for development products.
  • Manage interactions with Regulatory consultants and contract research organizations, as needed.
  • Work with technical and medical writing to manage documents preparation timelines and communicates with team members to maintain awareness of expectations, enable timely reviews, achieve milestones and document deliverables.
  • Work with CMC team to manage preparation of CMC documentation, as needed, per regulatory requirements.
  • Maintain archive and tracking of ongoing submissions.
  • Work directly with Regulatory Operations to get submissions published.
  • Support the Regulatory Affairs International / EU Lead as required.

QUALIFICATIONS

Education/Experience:

  • Degree in biological or life sciences, pharmacy or medicine (or international equivalent). An advanced degree is desirable with a minimum of 8 years in the pharmaceutical industry or relevant work experience and a minimum of 5 years in Regulatory Affairs.
  • Experience in the management of life cycle management activities such as submissions of variations, PSURs, Renewal procedures to the EMA, MHRA and Swissmedic.
  • Experience in the pre-MAA activities (such as ODDs, Scientific Advice, PIP) is a significant advantage.
  • Experience representing Regulatory Affairs on cross functional teams is desirable.
  • Excellent planning and organizational skills and the ability to work simultaneously on multiple projects with tight timelines.
  • Excellent communication skills both in writing and verbally.

Knowledge, Skills and Abilities:

  • Ability to work under minimal supervision of Regulatory Affairs professionals, but following detailed instruction with well-defined procedures.
  • Knowledge and experience relating to clinical trials would be desirable.

Work Environment:

  • This is a high growth, fast paced small organization. The ability to be productive and successful in a work environment is critical.
  • Willingness and ability to travel domestically and internationally is required, it is anticipated that this will be 5% of work time.

#LI-Onsite

Mirum Pharmaceuticals is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and Local laws that prohibit employment discrimination on the basis of race, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability, veteran’s status or any other classification protected by applicable State/Federal/Local laws.

Mirum Pharmaceuticals provides reasonable accommodation for qualified individuals with disabilities and disabled veterans in job application procedures.