HMZ-12 Associate Director Regulatory, Italy

HMZ-12 Associate Director Regulatory, Italy

04 mag
Vertex Italy Distribution
Roma Provincia

04 mag

Vertex Italy Distribution

Roma Provincia


- Act as main contact with local National Health Authority (HA) for Regulatory Activities

- Track all HA requests and relevant new local legislation and diligently forward to relevant GRA contact

- Provide regional and local regulatory expertise, maintain current knowledge of local requirements and anticipate, assess and communicate changes to local and RA Senior Management in a timely manner

- Obtaining national regulatory intelligence through interaction with HAs and participation with national industry organisations and committees

- Act as local expert for regulatory queries coming from other functions, e.g. medical and supply chain, on topics such as compassionate use, exemption from local labelling,

CTA requirements, etc.

- Submission and follow-up of CTA applications and amendments, compassionate use programs and national requirements related to MAAs and subsequent variations for Centrally Approved products

- Review and approval of translations for clinical trial labelling, artworks and Product Information

- Control the medical/promotional/institutional documents according to the local requirements (and submit or obtain an approval if required by the national regulation)

- Participate in local cross-functional launch activities

- Ensure all work is compliant with regulatory requirements and company policies and procedures


- Perform RP duties  as per GDP guidelines

- Ensure that the QMS in Vertex sites where acting as RP is implemented and maintained, including the management of authorised activities and quality of records.

- Ensure that initial and continuous training programs are implemented and maintained for Vertex staff involved in the Wholesale dealing operations.

- Coordinate and perform recall operations for Vertex sites where acting as RP.

- Work with Vertex Product Complaints team to ensure that customer complaints are dealt with effectively.

- Ensure that customers and suppliers are approved

- Approving any subcontracting that may impact GDP.

- Ensuring that self-inspections are performed at appropriate regular intervals following a prearranged program and necessary corrective measures are put in place.

- Deciding on the final disposition of returned, rejected, recalled or falsified medicines, including the approval of returns to saleable stock.

- Ensure that any additional requirements imposed on certain products by national law are adhered to.Keep appropriate records of delegated duties.


- As applicable, support and contribute to local cross-functional and leadership teams to achieve corporate and departmental goals and objectives.

- Exhibit ownership and accountability for all projects and internal assignments; plan, schedule and arrange own work activities with limited direction

- Attend meetings at local or international Vertex Offices

- Exemplify Vertex’s core values in fulfilling these job duties


- Extensive relevant industry experience in regulatory affairs and understanding of current trends in local and regional requirements.

- Recognized as a knowledgeable resource for regulatory advice by other departments

- Experience of managing complex negotiations with Regulatory Authorities

- Must be able to facilitate interactions with International Regulatory Affairs, other departments within the Company and external parties (national authorities, trade associations, professional bodies, etc.)


Acted as a Responsible Person named on a Wholesale Dealers Authorisation


- Desire to be part of a highly innovative company aimed at transforming the lives of people with serious diseases, their families and society.

- Good interpersonal skills and ability to deal effectively with a variety of personalities

- Strategic ability, as evidenced by an awareness of the "big picture" strategic issues facing the business overall and positioning of local strategy relative to global and international requirements

- Self-motivated with the ability and desire to take on new challenges, to help build an organization and still be part of a team taking a hands-on approach to projects.

- Team player, but also able to behave independently where needed, at the same time this individual must understand and embrace being part of a team and working collaboratively with others.

- Strong analytical ability; and an ability to deal with ambiguity, uncertainty and complexity

- Display solid ethics and fully comply with all regulatory, legal and industry codes of conduct.

- Ability to navigate and be successful in a fast-paced environment while delivering high quality results.

- Excellent communication skills, strong oral/written presentation skills.

- Fluent written and spoken English


- Bachelor’s degree in life sciences required

- M.Sc. or Ph.D. degree is preferred.


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