Regulatory Operations Manager - Biologics

Regulatory & Clinical Durham, NC


Description

 

 

At Bioventus we enable people to resume and enjoy active lives, every day!
 

Bioventus accomplishes this with its orthobiologic products for bone healing, regeneration and related biosurgery that engage and enhance the body’s natural healing processes. Bioventus currently has more than 750 employees globally; and are rapidly expanding.

Our mission is to become the global leader in Orthobiologics and each year more than 400,000 lives are changed by our products.

We are proud of the work we do and the lives we touch.
Do you want to be part of team to make that difference? Does working for a medical company in a young driven international environment interest you?  That’s what you can expect working at Bioventus.

 

Sound good to you? Read on!

 

Regulatory Operations Manager - Biologics

Location: Raleigh, Durham / full-time / 40% Travel requirement for the role

About your role

The Regulatory Operations Manager collaborates with internal team members and external partners to ensure critical regulatory documentation for Bioventus’ biotechnological/ cellular products are properly created and maintained. Responsibilities include the creation and maintenance of regulatory documents, including submissions made to health authorities that comply with applicable regulations, ICH guidelines, and industry standards. This encompasses critical regulatory documentation associated with new product development, correspondence with health authorities, and life-cycle management of marketed products.

Key Responsibilities:

  • Provides oversight for the team(s) responsible for biologic/drug submissions including the compilation, preparation, review and submission to health authorities;
  • Provides oversight to ensure processes are in place for the publishing of regulatory submissions according to ICH electronic Common Technical Document (eCTD) format and submission-ready standards;
  • Creates and maintains submission project plans;
  • Ensures team deliverables align with applicable regional, ICH, company, and partner defined standards;
  • Maintains technical expertise of regulatory submission requirements and ensures alignment with company processes and partner requirements;
  • Identifies resources and technologies needed to support submission activities and to resolve identified issues and risks;
  • Identifies resources and provides guidance for process updates due to changing regulations that impact submission strategies and technologies;
  • Acts as a resource to project teams to provide guidance in producing high-quality submission content;
  • Develops excellent relationships with internal functional groups and external collaborators;
  • Continues professional development by attending regulatory operations-related meetings applicable to biologic/drug dossiers;
  • Aids in the implementation of infrastructure necessary for successful completion of regulatory projects (e.g., preparation of regulatory-related written processes and procedures, review of department SOPs).

 

What do you bring? A feeling for new chances and the drive to take up new challenges

 

  • Bachelors degree;
  • Knowledge of, and experience in, electronic submissions (e.g., eCTD, NeeS) and document management;
  • Strong working knowledge of FDA and ICH requirements pertaining to eCTD submissions and data standards;
  • Working knowledge of current systems to support efficient creation and maintenance of critical regulatory documents;
  • 5+ years of experience performing Regulatory Operations support in the biotechnology or pharmaceutical industry;
  • 5+ years in creation and publication of electronic submissions in eCTD format;
  • Good oral and written communication skills, with the ability to communicate effectively and collaboratively with scientific and project management staff;
  • Excellent attention to detail with demonstrated organizational and time management skills;
  • Highly flexible, adaptable, and experienced in a fast-paced environment;
  • Prior experience preparing BLA submissions is strongly preferred;
  • Good oral and written communication skills, with the ability to communicate effectively and collaboratively with scientific and project management staff;
  • You are an active learner, seeking and leveraging opportunities to gain new skills, knowledge, and experiences.

Our ideal new colleague possesses strong interpersonal, listening and persuasive communication skills to give the best advice to internal stakeholders. You naturally strive for the best performance and you have the willingness to learn. Additionally, you are a good team player, dynamic, optimistic, accurate, result oriented, hard-working and creative.

What can you expect from us? Excellent working conditions and a very lively and supportive company culture

  • Working in an innovative and international environment;
  • Professional and personal development is supported;
  • Flat structures, independence within your role;
  • Sustainable and meaningful approach in everything we do;
  • Good work-life-balance;
  • A salary, depending on your experience, based on market practice;
  • Competitive bonus plans.

 

Besides that, we have a great team of international professionals in place that love what they do and enjoy spending time with each other.

 

Are you the Dynamic and driven talent we are looking for?

Then apply now by sending your CV and a brief motivation via the ‘Apply’ button.

 

We are looking forward to getting to know you.

Bioventus is an equal opportunities employer!