Symphogen A/S is facing an exciting and challenging period of growth, which offers the right job applicant great opportunities to influence job content and develop additional skills.
Regulatory Affairs is a highly important part of the drug development process and encompasses the whole human clinical trial process. Individuals within Regulatory Affairs focus on the ensuring regulatory strategy aligns with the business goals, interact with health authorities on behalf of Symphogen and complete all regulatory submissions. Do you have the right skills and want more influence strategically, and do you both have experience with the regulatory CMC as well as clinical regulatory experience, and are you also prepared to shoulder operational tasks as needed, then we can assure you a highly-engaged organization Company culture J and we would very much like to talk to you.
This position will support and manage the regulatory activities associated with the Symphogen product 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.
You will be reporting to the Director regulatory affairs in US, and work closely with internal stakeholders, affiliates and health authorities in Europe and USA.
Major Activities/Key Responsibilities
- New applications for biologics
- Plan/Prep/Submit/Review support for product dossiers
- CTA / IND and HA application preparation and maintenance
- License Maintenance
- Recurrent filings: annual reports
- Regulatory Submissions
- Regulatory strategy development
- Preparing / Authoring / Review of Submissions
- Technical Review of site supporting documents for regulatory submissions (CoA, declarations, SMF, MBR, SOPs)
- Notify Vendors/ CROs for publishing
- Response to Queries from Health Authorities
- Change Controls
- Change control assessments
- 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.
- Participate at Core team meetings
- Provides regulatory support for Research Review and Development Review monthly meetings
- Coordinates with US all regulatory activities
- University degree in scientific discipline with at least 10 years of total regulatory experience and at least 3 years of regulatory CMC experience.
- Experience in within the oncology/hematology disease area
- Knowledge of EMA, FDA, and EU country regulations is essential.
- Experience with IND, CTA, and Health Authority applications.
- Experience with biological products and their regulatory requirements
- Experience with both BLA and MAA applications
- Strong communication and language skills, written and verbal (Danish/English required)
- You are Self-driven, are proactive and like to take the initiative. highly motivated, team player with commitment, initiative, and humor
- You are a dedicated team player with commitment
- You are structured and able to prioritize your work in a fast paced and changing
- 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 Hanne Beirholm, Beirholm Search.
At 29 44 00 80
If you are interested in the position, please mark your application and CV: “Senior Manager – Regulatory Affairs” and email it to:firstname.lastname@example.org. Potential candidates will be invited for interview as they apply and we reserve the right to terminate before the posting expires.
We look forward to hearing from you!
Antibody therapeutics is currently the fastest growing business in the pharmaceutical industry. Following the historical success of monoclonal antibodies, Symphogen is striving to develop and commercialize superior antibody mixtures based on the diversity of the natural human immune system by use of Symphogen’s proprietary technology suite. Symphogen A/S has built an innovative oncology pipeline consisting of mAbs and mAb mixtures, and performs activities from early discovery to mid-stage clinical development, which translates into new and challenging opportunities for our organization and employees. Symphogen is located in Ballerup in the greater Copenhagen area. The company currently employs approximately 110 people.