Regulatory Specialist

vor 1 Woche

Frankfurt am Main, Deutschland PERMACON GmbH Frankfurt Vollzeit

**Your opportunity at an international company in the pharmaceutical industry**:
Our client, a leading company in the pharmaceutical industry, is looking to strengthen its team in** Frankfurt am Main** and is seeking a full-time **Regulatory Specialist (M/F/d) - Pharma / CMC** to start **as soon as possible.**
- 2 days per week remote work possible
- 37.5-hour work week with flexible working hours
- Attractive compensation package

**Your responsibilities**:

- Review internal procedures to ensure alignment with current regulatory authorizations
- Analyze operational updates to assess potential regulatory considerations
- Coordinate regulatory planning and execution at the site level in alignment with broader organizational frameworks
- Enable cross-functional awareness of global regulatory milestones to support operational readiness
- Offer strategic input for technological upgrades and process optimizations from a regulatory perspective
- Support documentation transfer and adaptation efforts for established products across various markets
- Prepare technical documentation in accordance with regulatory submission standards and language consistency
- Contribute to global authorization processes by assembling technical content and compliance documentation
- Oversee the handling of inquiries and follow-up actions related to regulatory submissions
- Develop formal responses to health authority communications in collaboration with technical teams
- Maintain alignment between site operations and regulatory functions at regional and global levels
- Identify and implement opportunities to enhance regulatory workflows and reduce complexity
- Provide functional expertise during compliance assessments and regulatory inspections
- Utilize digital platforms to manage documentation and support process development initiatives

**Qualifications and skills**:

- Pharmaceutical background involving laboratory, manufacturing, or analytical control preferred
- Regulatory CMC experience, ideally between one and five years
- Understanding of global regulations and awareness of health authority and industry developments advantageous
- Strategic problem-solving skills for complex technical and regulatory issues
- Demonstrates initiative, independent decision-making, and forward-thinking
- Effective communication with internal teams and external stakeholders
- Familiarity with chemical and biological product types desirable
- Experience with internal data management and documentation systems required
- Strong proficiency in both written and spoken **German and English** highly recommended

**What you can expect**:

- Hybrid work model and flexible working hours
- Permanent employment contract
- Transparent opportunity for direct placement with the client
- Competitive remuneration package, including bonus payments such as holiday and year-end bonuses
- Well-structured and thorough onboarding process
- Dedicated personal support throughout the assignment
- Access to exclusive employee discounts through established partner programs
- Exposure to leading international companies and corporate environments

Contact

**Your**_point of contact _**for this position**:
**Eirini Chrysafidou**:

- HR Consultant_

069-13872922

Permacon GmbH
Mainzer Landstraße 181
60327 Frankfurt

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