Regulatory Affairs Manager

IN BRIEF:

Shape the future of healthcare with Zentiva.
As our new Scientific Affairs Manager, you'll be at the heart of scientific affairs, partnering with health authorities, healthcare experts, and international teams to ensure compliance, support innovation, and bring medicines to patients efficiently and responsibly.

Diversity is a fact. Inclusion is an act @Zentiva

At Zentiva, we are a team of almost 5,000 unique talents bonded together by our mission to deliver high-quality medicine to people whose lives depend on it. We strive daily to create a work culture where everyone feels appreciated, can be their true selves, and contribute to the best of their ability. Seeking for a balanced team across the company, we welcome applications from all qualified candidates with various educational and industry experiences, cultural or ethnic backgrounds, and different life experiences or abilities, regardless of their religious or philosophical beliefs or whomever they choose to love. Join our winning team! Be a part of our winning culture! Be Zentiva! Information regarding the processing of personal data can be found here: https://www.zentiva.com/gdpr/recruitment-privacy-notice.

PURPOSE OF ROLE
Scientific Affairs Manager is accountable for leading the scientific affairs function (including Regulatory affairs, Medical, Pharmacovigilance and Quality function): within Zentiva Estonia branch.

MAIN TASKS:

• Daily regulatory tasks for new registrations, portfolio maintenance processes in cooperate closely with Global RA team.
• Ensure AW management process.
• Act as Local PV contact point. Ensure appropriate ICSR management and additional risk minimization measure local implementation.  
• Oversight and management of Medical Information enquiries. Support Promotional material approvals.
• Local Regulatory, PV and Quality contact with local Authorities.

REQUIREMENTS:

• University Scientific Degree (Pharmacy, Medical, Chemistry, Biology, Veterinary)
• Minimum 5 years of experience in Pharmaceutical Industry
• Expert knowledge of the structure and management of the relevant national health system, orientation in valid regulations
• Excellent Estonian and proficient level of English (spoken and written)
• Solid IT knowledge (MS Office programs)
• Good interpersonal relations and communication skills
• Teamwork-oriented and willing to learn new systems and disciplines

ZENTIVA OFFERS:

• An opportunity to work for a successful international pharmaceutical company
• An opportunity to learn the newest approaches in managing creative and highly adaptive business organizations
• Competitive remuneration package
• Possibility to grow, learn, and develop
• Work in a multicultural environment in hybrid mode

APPLY OR WANT TO HEAR MORE? PLEASE CONTACT:

We hire when we find the right person for the job, and we will contact only relevant applicants.

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