Manager - Regulatory Affairs CMC Somerville United States,
This position will support and manage the regulatory activities associated with the Chemistry, Manufacturing, and Controls for clinical portfolio, which consists of monoclonal antibodies and monoclonal antibody mixtures. This position will provide input into the product strategy and to the direction provided to the clinical teams. Incumbent will be responsible for assuring the established regulatory strategy is aligned with Health Authority requirements from a global perspective and assuring that regulatory submissions are on time and high quality.
Provide support for other CMC projects as needed. Experience working in a matrix environment and excellent people skills are required.
Additional duties include coordination with our core teams and assisting in other regulatory affairs activities within the company as well as assisting in European regulatory activities for all programs as needed.
Major Activities/Key Responsibilities
- New applications for biologics
o Plan/Prep/Submit/Review support for product dossiers
o CTA / IND preparation and maintenance
- License Maintenance
o Recurrent filings: annual reports
- Regulatory Submissions
o Regulatory strategy development
o Preparing / Authoring / Review of Submissions
o Technical Review of site supporting documents for regulatory submissions (CoA, declarations, SMF, MBR, SOPs)
o Notify Vendors/ CROs for publishing
o Response to Queries from Health Authorities
- Change Controls
o Change control assessments
o Initiate change in regulatory database and ensuring regulatory submissions are completed as required
- Provide interpretive analyses regarding impact of complex regulatory guidance documents, regulations, or directives that impact company products and operations.
- University degree in scientific discipline with at least 7 years of total regulatory experience and at least 3 years of regulatory CMC experience
- Knowledge of FDA and EMA regulations is essential.
- Experience with IND and CTA applications.
- Experience with biological products
- Strong communication and language skills, written and verbal (Danish/English)
- Self-driven, highly motivated, team player with commitment, initiative, and humor
- Proficient in MS Word, Excel, and PowerPoint
- Excellent organizational and communication (written and verbal) skills.
- Demonstrated ability to work successfully on project teams.
- Experience with both BLA and MAA applications
- Experience in within the oncology/hematology disease area
- Previous experience working in a fast-paced environment on multiple product lines
- Manufacturing, QA/QC experience
- A challenging and versatile job in an innovative, flexible, focused and committed biotech environment
- Competitive salary based on qualifications
- Compensation package including a personalized and company-wide bonus system, flexible working hours and an inspiring working environment
Working in Symphogen
When being a part of Symphogen you will always have a challenging job in a creative, goal-oriented, value-based biotech environment with a meaningful mission. You will be a part of a highly-engaged organization with a passion of being the worldwide leading recombinant polyclonal antibody company.
You will have good development opportunities, in an organization that is inspiring and growing, with focus on diversity, teamwork, commitment, and you as a person.
For further information
For more information you are welcome to contact Ivan Horak, Head of Global R&D at firstname.lastname@example.org or HR-Director, Lisbet L
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