Work as SSU & Regulatory Specialist at Syneos Health

Syneos Health™ is an end-to-end, fully integrated biopharmaceutical solutions company that works differently. At Syneos Health, all the disciplines involved in bringing new therapies to market, from clinical to commercial, work together to create customer success. Our unique Biopharmaceutical Acceleration Model delivers value across the small to mid-size to large customer continuum.

Post : SSU & Regulatory Specialist II

Job Description
a) To undertake all necessary dossier elaboration, evaluation and timely dispatch for regulatory submission in accordance to local regulations with agreed business priorities to ensure compliance of all assigned products in the given cluster of countries.
b) To assist with development of optimal regulatory strategies in collaboration with key internal stakeholders to drive early submission and approvals in accordance with agreed business priorities.
c) Keep up-to-date with developments in regulatory affairs and assist with implementation of any required revisions to systems and processes.
d) Contribute technical support to the areas of quality control and technical product development regarding the dossiers sent to the region to progressively improve the quality of our dossiers in a way that conforms to the regulatory guidelines.
e) Ensure the quality of files sent, avoiding or decreasing, the number of observations of the from Health Authority, in order to avoid delay in the processing times
f) Ensure the follow up and traceability of the regulatory process concerning the dossiers sent, submitted and records obtained, in the different countries.
g) Manage the response of deficiency letters from HAs of the countries in charge (review information, coordinate times of response)
h) Ensure the delivery of the dossier to the affiliate, with risk assessment without impacting the dates of submission.
i) Ensure the answer to the requirements of the affiliates and authorities of the regulatory agencies on time.
j) To assist in regulatory activities needed to maintain marketing authorisation in the cluster responsible
k) Coordinate translation of the dossiers when required according to the local legislation

Candidate Profile
• Education : Tertiary qualifications in pharmacy or life sciences
• Experience and knowledge: Minimum of 2 years of relevant experience in similar position in the pharmaceutical industry.
• Strive for results, Commitment to Customer, Cooperate Transversally.
• Demonstrate and recognize capacity to work in a matrix organization;
• Strong teamwork ability: interpersonal & communication skills;
• Demonstrate capacity to Act for Change;
• Ability to Make Decisions;
• Excellent strategic, networking and influencing skills;
• Strong Knowledge of regulatory requirements for variations, renewal and labeling of countries under his/her responsibility
• Language requirements: Good level of spoken and written English. Addition of local language in based country may be an advantage

Additional Information
Qualification : B.Pharm, B.Sc
Experience : 2+ years
Industry Type : Pharma
Functional Area : Regulatory
End Date : 30th October, 2019