Regulatory Affairs, Quality & Safety Senior Manager

Regulatory Affairs/Clinical Affairs Bucharest, Romania


Descripción

Job Description

Regulatory & Quality & Safety Affairs manager /senior manager Romania/Moldova

 

Job outline

An exciting opportunity to join a dynamic, game-changing team within a rapidly growing healthcare company with a diverse portfolio. The role scope depending on the level of the candidate is either to be the functional country lead of the regulatory, quality and safety operations or Regulatory/Safety/Quality manager in Romania and Moldova.

The role on either level will be responsible to

  • lead and manage regulatory operations for Romania and Moldova for the relevant brands in the local portfolio and ensure smooth operations with the relevant consultants in Moldova
  • support and/or manage quality operations. Potential for covering deputy responsible person (dRP) and/or responsible person (RP) responsibilities if relevant
  • support and manage safety/vigilance operations as LCP (Local Contact Person for Vigilance) or deputy LCP
  • ensure smooth operations with the relevant consultants in Moldova

On the top of this the senior manager/functional lead level role will also lead the regulatory, quality, safety team in Romania and ensure smooth operations with the relevant consultants in Moldova.

The role on both levels will attract a high level of autonomy and responsibility for management of workload and priorities and will be visible to senior levels of the local and international business.

 

Key Responsibilities

Regulatory:

  1. Ensuring the regulatory compliance, appropriate licensing, marketing, and legal compliance of the products in the assigned portfolio
  2. Handling NPD and Life Cycle Management activities for medicinal products, medical devices, biocides, food supplements and cosmetics for assigned brands as part of the company’s portfolio
  3. Enabling Commercial Strategy and manage regulatory submissions: development of local regulatory strategy for new product registration & licence maintenance and relevant submissions, fully aligned to business needs. Actively contribute to and define claims-support rationale, to obtain the strongest commercial platform possible.
  4. Managing new registrations, variations, renewals, post approval commitments, RFIs for assigned brands.
  5. Preparation of documentation for submissions and working in the relevant systems for assigned brands
  6. Manage regulatory submissions and ensure timely approval for assigned brands
  7. Reviewing and regulatory approval of packaging and promotional materials, claims, artwork and product information for assigned brands
  8. Managing promotional materials and VISAs and other relevant health authority approvals for the assigned brands
  9. Analyzing the RA information and providing regulatory intelligence regarding Romania/Moldova and collaborating closely with consultants in Moldova for industry insight
  10. Working cross-functionally with central and local teams (regulatory, quality, safety, marketing, innovation, supply, sales etc) for pipeline projects, including product launches, product changes, promotional materials, artworks, labelling etc
  11. Networking and communicating with relevant authorities, key bodies, and trade associations regarding new MAA, renewals, licenses, variations, and cancellations for assigned products and to support the projects and tasks related to the portfolio in Romania and Moldova
  12. Keeping abreast of European and National legislation

 

Quality and Safety:

  1. Supporting/ensuring compliance with the relevant legal obligations in the area of drugs, medical devices, food supplements , cosmetics and biocides . Ensuring vigilance for the product portfolio of the company for all types of products (pharmacovigilance, medvigilance , materiovigilance etc) and compliance with QA requirements. 
  2. Supporting / ensuring establishment and maintenance of quality : - ISO 9001 and GDP. Supporting/ensuring compliance with GDP and ISO and for all relevant local quality operations and systems including local batch release and audits etc. Supervising the quality of contract manufacturing on local level. Support or ensure local QMS maintenance in line with relevant local and EU requirements as well as the global Perrigo company guidelines and principles.
  3. Covering deputy Responsible person or responsible Person responsibilities if relevant depending on company needs
  4. Fulfilling Safety LCP or deputy LCP responsibilities

 

 

Stakeholder management:

  1. Internal Stakeholder Management: Effectively manage expectations across a broad range of business stakeholders, employing high quality communications in all interactions.
  2. External Relations: Continue to build strong relationships with Regulatory Authorities, Trade Associations & Key Opinion Leaders, forming a go-to network for strategy development and problem solving. Ensure communication with state health authorities in the area of all product types in the local portfolio.                                                                                                     Consultancy management : Manage relevant consultants in Moldova.

 

  1. Line Management (on senior manager/functional lead level): lead and effectively manage the regulatory, quality, safety team in Romania and ensure smooth operations with the relevant consultants in Moldova.
  2. Budget management: effectively manage (senior manager/functional lead level) or support (manager level) local Regulatory/Safety /Quality budget and ensure it is regularly discussed and get aligned with relevant stakeholders
  3. The role reports to the Director of Regulatory Affairs & Quality & Safety Operations -Central East Europe region , and will be based in the Perrigo Romania SRL office in Bucharest.

 

 

Person Specification

Education & experience required:

  • Educated to degree level within life sciences. Pharmacist degree is beneficial.

 

  • 6+ years experience (senior manager/functional lead level) or 4+ years experience (manager level) working within regulatory affairs, ideally within OTC sector, and good industry insight
  • Experience includes Medicines and Medical devices; with Medicines experience spanning new MAAs (with awareness of National Procedures/DCP/MRP), as well as management of line extensions and licence maintenance activities.
  • Experience with Food Supplements, Biocides and Cosmetics would also be beneficial.
  • Good commercial understanding and a ‘sales enabling’ regulatory mindset, identifying opportunities and building a regulatory strategy which aligns to business needs
  • Experience in reviewing product claims and advertising materials across product types.
  • Experience with Pharmacovigilance and materiovigilance systems
  • Experience within Quality affairs for medicines and medical devices and understanding GDP and ISO requirements is beneficial for the manager level role and required for the senior manager/functional lead level role.
  • Fluent in Romanian and English

 

Personality profile:

  • Able to critique data, assess probability of success and adapt based on strength of position
  • Good negotiation and communication skills, able to adapt style to audience (Regulatory Authorities, notified bodies, policy makers, etc)
  • Capable to foster collaboration with other functions and departments, at all levels, and to act as an equal partner and valued voice in all interactions
  • Able to prioritise in line with business needs, managing stakeholders and expectations
  • Passionate and energetic, with a “can do” mentality
  • Able to handle multiple tasks in a fast-paced and changing environment, while having a hands-on approach, and entrepreneurial mindset
  • Capable to work independently and self-start to define a path and gather knowledge
  • Takes initiative, looks for opportunities to do more, and takes risk when justified
  • Displays thoroughness in analysis and follow-up
  • Generates creative solutions to problems faced and is able to make decisions in ambiguous situations
  • Demonstrates empathy and respect for people, takes responsibility, and communicates with confidence and tact, confronting issues appropriately

 

We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better.