Regulatory CMC Senior Manager

Regulatory & Clinical Raleigh, North Carolina


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 CMC Senior Manager - Biologics

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

About your role

The Regulatory CMC Senior Manager will provide leadership to ensure that development activities, manufacturing, and testing for Bioventus’ biotechnological/cellular products are compliant with the relevant regulations, guidelines, and industry standards.  Responsibilities include developing, collecting, writing, reviewing, and assembling CMC-related submission documentation and ensuring appropriate internal review and approval prior to submitting to a Regulatory Authority.

The primary tasks in this position will be set but not limited to the following areas:

  • Proactively manages CMC aspects of one or more products in early-to-late development through interactions with multiple functions to create high quality regulatory submissions that support the product development strategy; ensures the development strategy meets global regulatory requirements over the lifecycle of each product;
  • Interacts with Product/Process Development, Operations, Quality Control, and Quality Assurance personnel contributing to a submission regarding content and timelines; ensures that sections provided to Regulatory are consistent with requirements and internal submission format standards;
  • Leads and/or actively participates in the establishment of DS/DP specifications;
  • Supports transfer of analytical methods and manufacturing processes from R&D to Operations;
  • Writes and/or reviews and edits module 2 QOS and module 3 sections for all investigational, marketing approvals, and post marketing applications;
  • Manages execution of submission preparation, review, approval, and submission to the appropriate Health Authorities;
  • Represents CMC function on assigned cross-functional project teams;
  • Researches and interprets global CMC regulations and provides regulatory guidance to project teams;
  • Provides accurate regulatory assessments of CMC changes to teams/projects and executes regulatory planning and implementation;
  • Reviews and provides comments on SOPs, stability protocols, product container labeling, product specifications, comparability protocols and reports, quality agreements, pharmacy manuals, investigator brochures, and other related CMC documents;
  • Develops excellent relationships with internal functional groups, contract manufacturing organizations, and external collaborators;
  • Continues professional development by attending regulatory CMC-related meetings applicable to biopharmaceutical products;
  • 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

 

  • PhD degree in Biology, Chemistry, Biochemistry, Bioengineering, or a related scientific field;
  • Demonstrated ability to prepare and critically review QOS for biotechnological/ cellular products (including establishment of DS/DP specifications);
  • Strong working knowledge of relevant FDA/EMA/HC regulations and guidelines (as well as relevant ICH guidelines) for biotechnological/cellular products;
  • Understanding of scientific basis for product CMC strategy;
  • 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;
  • 8+ years of CMC experience in the biotechnology or pharmaceutical industry (preferably with exposure to cGMP and both development and commercial phases of a product lifecycle);
  • Direct experience in CMC for licensed and/or investigational biotechnological/cellular products;
  • Experience leading interactions with Health Authorities;
  • Direct experience preparing Regulatory applications in CTD format;
  • Prior experience preparing a BLA 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!