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Regulatory Affairs Specialist
MSc. Life Sciences, Regulatory Affairs, CMC writing, Module 3
Job
CLS Services is a leading professional recruitment agency specialised in chemistry & life sciences.For our client Batavia Biosciences we are searching for a Regulatory Affairs Specialist.
Keywords
- MSc. Life Sciences
- Regulatory Affairs
- CMC writing
- Module 3
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For Batavia Biosciences we are looking for a Regulatory Affairs Specialist. In this role you are responsible for providing regulatory documents describing CMC related activities and data applicable to Batavia and/or the Client’s manufacturing process operated at Batavia. This shall be driven by close interaction with regulatory bodies, Clients and Batavia’s internal contacts.
Responsibilities:
- Advising others, both internally as well as clients, on matters that are related to regulatory processes and compliance. Therefore, you provide correct and accurate technical review of data or reports in relation to regulatory pharmaceutical compliance;
- Oversee the planning, coordination, and management of regulatory documentation activities: Examining, identifying, and interpreting relevant regulatory guidelines.
- Analyse and evaluating laws and regulations that apply to the process of determining the impact on company activities in relation to submitting the relevant data to clients and government agencies.
- Compiling and overseeing the maintenance of regulatory documentation and databases or systems.
- Coordinate efforts that are related to the preparation of regulatory documents or submissions to clients and government agencies;
- Developing and maintaining healthy communication with clients and regulatory agencies regarding (pre-)submission strategies, compliance test requirements, potential regulatory pathways, or clarification, and follow-up on submissions still under review.
Profile
We are looking for candidates with an MSc. in Life Sciences and several years of experience in Regulatory Affairs. Experience in writing CMC modules (including Module 3) is essential for this position. You are effectively capable to work with regulations, directives, policies, and procedures in the biopharmaceutical field. Ensuring adequate compliance with regulations for (bio)pharmaceutical regulations and legislation.Requirements:
- Well-developed written and oral communication and interpersonal skills to frequently work with other employees, team members, clients and governmental bodies, and also advise others on compliance and regulatory matters;
- Good time management skills, as a regulatory affairs specialist, must be able to work effectively in a demanding environment where strict timelines and protocols must be met;
- Experience with information management tools;
- Excellent organizational and project management skills to frequently coordinate complex activities, often with competing priorities;
- Well-developed analytical skills and the ability to pay attention to details.
Company profile
Batavia Biosciences focuses on accelerating the transition of biopharmaceutical product candidates from discovery to the clinic with improved success and lower cost.Their services cover candidate selection, production of research materials, upstream and downstream process development, assay development, product characterization and clinical manufacturing and release.
Batavia Biosciences has successfully worked on viral and bacterial vaccines, recombinant proteins, antibodies and gene therapy products. Unique technologies such as STEP™ protein expression technology and SCOUT™ high throughput process technology accelerate timelines and reduce costs.
Core values Batavia Biomanufacturing:
Drive; We are energetic, passionate and intrinsically motivated.
Flexibility: We embrace new ideas, are adaptive and open to changes.
Scientific excellence: We strive to be a scientific point of reference to our customers, colleagues and other stakeholders.
Quality: We highly value quality in every aspect of our work, and understand it is key to product delivery.
