30 days old

Regulatory Manager

Pfizer
Bulgaria
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**JOB INFORMATION**

**JOB SUMMARY**

Execution of clinical trial with Bulgarian Drug Agency, new marketing authorizations and product lifecycle maintenance activities in line with business priorities and in compliance with internal procedures.

Provision of strategic regulatory input to local cross-functional team and above country regulatory partners as required for the assets under responsibility throughout the whole asset's lifecycle.



**JOB RESPONSIBILITIES**

Liaise with clinical research project managers to seek to understand clinical research programme.



In partnership with above-country operational hubs, above-country global regulatory strategists, and local clinical operations or third party vendors, prepare agreed CTA submission documentation for both initial application and subsequent amendments, and other maintenance activities for the lifecycle of the CTA including response to Regulatory Authority queries.



Ensure timely communication of any GCP breaches, or actions taken for safety reasons.



Execution of new registration and product maintenance activities related to his/her therapy area/ products under his/ her responsibility in line with internal SOPs in force.



Monitor regulatory activities related to his/her therapy area/products under his/her responsibility and, if required, across product therapy areas and assist with the management of projects as necessary to ensure compliance with regulatory authority and corporate requirements.



Ensure timely regulatory activities are carried out and tracked.



Ensure notifications of proposed regulatory changes and approvals are provided to relevant stakeholders in a timely manner.



Ensures full compliance/inspection-audit readiness as established by internal SOPs.



Completes mandatory training within defined timelines.



Provision of regulatory strategic input to the local and above country asset teams.



Participate in/lead, cross-functional project teams, to address business needs in line with business objectives and strategic imperatives.



Support Head of Regulatory Affairs Bulgaria when identifying, implementing and managing key RA Departmental projects.



Play a leading role in ensuring that the RA Department has effective and efficient processes in place.



Establish and build on relationships with key customers (internal and external) at a local level. Act as an Ambassador for the RA Department.



Develop and enhance working relationships with Regulatory Authorities and trade associations.



Develop and enact appropriate influencing strategies in order to negotiate optimal outcomes for the business on product issues.



Utilise local knowledge of Regulatory Authority's expectations, ways of working etc. to appropriately direct company strategy. Share updates with colleagues.



Extract, evaluate and report on relevant information in anticipation of customer's needs or in response to customer enquiries.



Provide input to GRA regulatory line managers for the development of products in-line with business objectives.



Provide input to the local and international Pfizer business units strategic planning process as appropriate.



Provision of ongoing coaching, guidance and sharing of regulatory expertise.



**QUALIFICATIONS / SKILLS**

Life sciences or chemistry graduate to honours level or equivalent are preferred.

Appropriate Regulatory Affairs experience - minimum 3 years

Computer literacy

Bulgarian language proficiency

Foreign languages: Fluent in written and spoken English



Knowledge of the European regulatory/clinical trials legislation



Strategic Thinking: Provides strategic contribution and anticipates what RA needs to contribute to develop and achieve business objectives. Effectively explores alternative regulatory strategies and positions to reach outcomes that gain the support and acceptance of all parties.



Communications skills: Clearly conveys information and ideas through a variety of media to individuals or groups in a manner that engages the audience and helps them understand the message.



Negotiation skills: Can negotiate skillfully in tough situations with both internal and external groups. Can be direct and forceful as well as diplomatic. Gains trust quickly of other parties to the negotiations. Has built a strong relationship with the local health agency and other relevant stakeholders (KOL's) and pro-actively manages issues with the HA's and other key external stakeholders.



Problem Solving: Effectively identifies issues and challenges and works with partner groups to identify options and implement agreed solutions.



\#LI-PFE



Pfizer is an equal opportunity employer and complies with all applicable equal employment opportunity legislation in each jurisdiction in which it operates.



Regulatory Affairs
Posted: 2020-03-02 Expires: 2020-04-02

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Regulatory Manager

Pfizer
Bulgaria

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