Regulatory Affairs Manager

**Our Company**:
Basic Pharma, a unique Dutch pharmaceutical company, is rapidly expanding, continually strengthening its organizational foundation, and advancing its specialization within the pharmaceutical industry. From product development, registration, production, and commercialization of (bio)pharmaceutical products to providing pharmaceutical services, Basic Pharma serves a diverse clientele ranging from startups to multinational corporations, both nationally and internationally.

Basic Pharma Manufacturing, manufactures various products such as nasal sprays, filled syringes, creams, and ointments. It also offers study medications and diverse services to third parties, including quality control and contract manufacturing.

Basic Pharma Technologies focuses on developing pharmaceutical products collaboratively with partners for its production organization and out-licenses them to customers. This unit now operates a biotech facility dedicated to product development and study medications.

Interdos specializes in providing consultancy services in the Regulatory Affairs, Pharmacovigilance, and Quality Management fields. Our expertise extends not only to internal support for Basic Pharma but also to external partnerships, ensuring seamless compliance and quality standards across the pharmaceutical landscape.

The synergy of these activities under one roof positions Basic Pharma as a resilient and versatile player in the pharmaceutical industry. With approximately 200 professionals, Basic Pharma's ambitions are expanding, prompting the search for individuals committed to professionalism and customer satisfaction. If this resonates with you, consider the following exciting opportunity.

**Position Available at Interdos**:
**Regulatory Affairs Manager**

**What will you be working on?**:

- Compiling and managing registration dossiers for pharmaceutical products with the aim of obtaining registration in predefined markets, within established timelines and in consultation with the client.
- For this vacancy particular focus lies on the collaboration with the Basic Pharma Technologies Product Development team and in close collaboration with the internal core team meeting, starting from early formulation, process and analytical method development, support ongoing dossier compilation for submission to the competent authorities.
- Managing, planning, and coordinating variations in accordance with applicable guidelines. Provide the Basic Pharma Technologies Product Development team with regulatory strategies suggestions and concerns related to their formulation, process and analytical method development and validation strategies.
- Achieving milestones and deadlines related to predefined development dossier goals and targets.
- Effectively communicating with those directly involved in the licensing process (internally and externally) and competent regulatory authorities.
- Excellent soft skills and eagerness to communicate within an internal core team meeting with the Basic Pharma Technologies Product Development team, where everyone comes together from their areas of expertise to support the common goal of dossier registration.
- Drafting reports (internal and external).

**Requirements for a Regulatory Affairs Manager?**:

- Minimum 5 years of experience performing various regulatory affairs duties within a pharmaceutical company;
- Thorough knowledge of EU and national regulations/guidelines in the field of regulatory affairs;
- Solid understanding of compiling, updating, and amending registration dossiers, as well as electronic submission processes;
- Proficiency in Word, Excel, and (preferably) Adobe Acrobat;
- Familiarity with Medical Devices and Drug Device Combinations is a plus.
- Excellent command of both Dutch and English languages, both written and verbal;
- Detail-oriented, with strong planning, organizational skills, and results-driven mindset

**What we offer**:

- A challenging and responsible position within a dynamic, growing organization.
- Competitive salary and benefits package (including flexible working hours, hybrid work options, 28 vacation days, pension, etc.).
- Opportunities for professional development and growth.
- An inspiring and collegial work environment with an international character.

**We do not appreciate acquisition in response to this vacancy**

***Vacancy**:

- Employer
- Interdos Pharma B.V.
- **Characteristics**:

- Hours/week
- Study
- Relevante trainingen op gebied van RA
- Experience
- 6-10 jaar
- Educational attainment
- HBO
- **Vragen over deze vacature?