Regulatory & Safety Affairs senior associate Adriatics

Job Description

Regulatory & Safety Affairs senior associate Adriatics

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 is a senior associate responsible for regulatory and safety operations in Adriatics region. The role will attract a good level of autonomy and responsibility for the tasks and  projects  and stakeholder management. The role involves managing regulatory and safety operations and projects in the Adriatic countries including Bulgaria, Slovenia, Croatia, Bosnia and Serbia directly as well as via relevant local consultants. The role is aiming to be best in class in the industry and will be visible to senior levels of the local and international business. 

Key Responsibilities

1. Support enablement of Commercial Strategy: Development of local regulatory strategy for new product registration & licence maintenance, fully aligned to business needs. Actively contribute to and define claims-support rationale, to obtain the strongest commercial platform possible.

2. Ensure compliance: with all legal obligations in the area of drugs, medical devices, food supplements, cosmetics and biocides. Ensure vigilance for the local product portfolio in the Adriatic countries for all types of products (pharmacovigilance, medvigilance, materiovigilance etc) . Including oversight, identification, training and monitoring of process improvements and ongoing compliance.

3. Regulatory submissions and dossier preparation:

a. Ensure and responsible for submissions and approvals for new product development and life cycle maintenance for all types of products (drugs, medical devices, food supplements, cosmetics and biocides) in the Adriatic region product portfolio including new registrations, renewals, variations, safety updates and notifications etc.

b. Ensure preparation of the local part of dossier and adaptation of global dossier to national requirements. Cooperate with global and local functions within the company as well as local consultants as relevant to ensure dossier preparation, handling and submission.

c. Responsible for products management including product name strategy, the production of product information texts, review of claims, advertising materials, reps training materials and pack design.

d. Responsible of artworks updates, reviews and new artworks as part of variations submission or new product launch and liaison with other functions to manage implementation. Direct responsibility for handling artworks for the relevant products and countries and/or ensue smooth artwork management via the relevant local consultants.

e. Support the management on brand portfolio development on the local level.

f.  Liaise with authorities responsible for the marketing authorization in the relevant countries

4. Safety and Pharmacovigilance/Vigilance:

a. Ensure proper functioning and maintenance of safety pharmacovigilance/vigilance systems in the Adriatic countries with collaboration of the relevant local consultants.

b. Responsible for safety activities and compliance for for all types of products in the product portfolio in the Adriatic region. 

c. Perform the task of the local contact person (LCP) for pharmacovigilance/vigilance in the relevant country(ies) and work closely together with contractor LCPs in the rest of the countries to ensure full safety compliance and smooth operations across the Adriatics region. 

d. Ensure submission of all related documents in accordance with regulatory requirements and good pharmacovigilance/vigilance practices. 

e. Coordinate and manage safety/efficacy complaints, adverse events, medical enquiries  and ensure relevant reporting and information storage and tracking.           

f.  Conduct PV/safety trainings within the company and for third parties as necessary.            

g. Prepare and update Pharmacovigilance and Safety agreements and control the requirement for exchange of information on pharmacovigilance/vigilance within the company and with third parties.

5. Audits and Inspections: Support regulatory and safety inspections and audits in the Adriatics countries

6. Internal Stakeholder Management: Effectively manage expectations across a broad range of business stakeholders, employing high quality communications in all interactions.

7. External Relations and consultancy management: 

a. Continue to build strong relationships with Regulatory Authorities, Trade Associations & Key Opinion Leaders, forming a go-to network for strategy development and problem solving. 

b. Ensure communication with state health authorities in the area of all product types in the local portfolio.

c. Effectively manage local consultants in the relevant countries to ensure smooth regulatory and safety operations across the Adriatic region. 

8. Budget management: Support and coordinate Regulatory/Safety budget preparation for the Adriatic countries 

The role reports to the Cluster Head of Regulatory Affairs & Quality & Safety Operations  and could  be based either in the Perrigo Bulgaria office in Sofia or Perrigo Serbia (Adriatic Distribution doo) office in Beograd or Perrigo (Omega Pharma) Hellas office in Athens. 

We offer opportunity of flexible work arrangement of partly working from home and partly office based. 

Person Specification

Education & experience required:

• Educated to degree level within life sciences. Pharmacist degree is beneficial.
• Substantial experience (2+ years) working within regulatory affairs, ideally within OTC 
• 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 Traditional Herbal Medicinal Products, Biocides, Food Supplements, and Cosmetics would also be beneficial.
• Involvement in the generation/review of product claims and advertising materials across product types. 
• Experience with Pharmacovigilance and materiovigilance systems
• Fluent English
• Fluent Slovenian or Croatian or Serbian and good understanding of the local legislation and experience with the relevant health authorities in Slovenia or Croatia or Serbia
• Alternatively fluent Bulgarian and good understanding of the local legislation and experience with the relevant health authorities in Bulgaria could be also beneficial 
• Reference: weYe5COxcHNdispikaPzqNvXZdoC_OBWH4mSG6mc96g.

Values & Competencies sought:

Show Passion and Energy

Able to work relatively independently and gather knowledge

• ‘Can do’ mentality to get the job done
• Ability to work and prioritise in line with business needs, managing stakeholders & expectations.
• Go The Extra Mile
• Always looks for opportunities to do more
• Takes initiative and takes risk when justified
• Displays thoroughness in analysis and follow-up. 
• Change the Game 
• Generates creative solutions to problems faced
• A ‘sales enabling’ regulatory mindset. 
• Be Curious and Savvy
• Curious about the OTC and non-medicine healthcare landscape and potential opportunities for Perrigo
• Savvy enough to understand the commercial priorities and identify opportunities that complement, building regulatory strategy which aligns to business need
• Ability to critique data, assess probability of success and adapt based on strength of position
• Impactful communicator, able to adapt style to audience (Regulatory Authorities, notified bodies, external and internal stakeholders etc).
• Be Open and Gracious
• Demonstrates empathy & respect for people
• Fosters collaboration with other functions & departments & external consultants and partners and acts as an equal partner and valued voice in all interactions
• Communicates with confidence and tact
• Holds themselves and others accountable by confronting issues appropriately.