Regulatory Affairs Manager

Debiopharm is a private, Swiss-based biopharmaceutical company. Mainly focused in oncology and bacterial infections, _
- the company develops innovative therapies that target high unmet medical needs with an ambition to improve patient _
- quality of life. Debiopharm Research & Manufacturing S.A., based in Martigny, is a pharmaceutical research, _
- development and production facility, inspected and registered with the main regulatory authorities. The Company is a _
- world leader in polylactic-co-glycolic acid (PLGA)-based injectable, sustained-release technology._

For his Technical Operations Department, Debiopharm Research & Manufacturing in Martigny is looking for a

**REGULATORY AFFAIRS MANAGER,** 100%

**Your Mission**:
Manage all post marketing regulatory activities of chemical pharmaceutical drug products including renewals, CMC variations, update of Labeling, extension of indications.

**Your Responsibilities**:

- Maintenance of registration files for all post-approval activities.
- To author, review and lead high quality documents for regulatory submissions.
- Prepare response to questions raised by competent regulatory agencies.
- Provide expert content guidance for quality portions of the CTD, ensuring compliance of documentation to internal company standards and external regulatory guidelines.
- Coordinate with partners’ regional regulatory teams for global strategy.
- Define, develop and lead regulatory strategies for post-marketing activities.
- Assess internal change controls.
- Maintenance and update of the Product Information.
- Internal Regulatory contact for Pharmacovigilance and Marketing and Business.
- Keep up to date Regulatory Information Management System.
- Maintain policy & regulatory intelligence.
- Provide regulatory strategies for projects as RA representative in cross-functional teams.

**Requirements**:
**Your Profile**:

- Degree in Science (e.g. Chemistry, Pharmacy) or equivalent.
- Min 5 years’ experience in **Pharmaceutical regulatory affairs** for **sterile parenteral** chemical drugs, ideally prolonged-release formulation.
- Maintenance, Renewal, Update Labeling, Extension of indications.
- Good knowledge of **ICH Quality standards**, European and US pharmacopoeias, International **CMC **Guidances, including ASEAN.
- Previous experience in meeting with Health agencies.
- Fluent in **French **and **English.**:

- Strong attention to details and organizational skills required.
- Good written and oral communication, technical writing and editing skills.
- Ability to handle different topics and willingness to learn.
- Demonstrate good interpersonal skills, ability to work with others in an international team environment, effective interactions in cross department teams.
- Orientation for work result details, with emphasis on accuracy and completenessAt least 2 years of experience in **pharmacovigilance**.